Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-26 @ 6:26 PM
Study NCT ID:
NCT02436356
Status:
TERMINATED
Last Update Posted:
2020-11-02
First Post:
2015-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
New Tools for Assessing Fracture Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffry.s.nyman@vumc.org', 'phone': '615-936-6296', 'title': 'Jeffry S. Nyman, Ph.D.', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'otherDetails': "Sponsor has 30 days prior to proposed submission date/release of publication to review results, provide comments. Within 30 days of receipt of proposed publication, Sponsor shall advise PI in writing if information contains Sponsor's confidential information (CI) or patentable matter. In addition, upon written request by Sponsor, PI shall delay submission of such publication for an additional 60 days in order to allow Active Life to apply for patent or other protection for Sponsor inventions.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination of the study occurred in February 2020 when the FDA determined the OsteoProbe is a significant risk device that would require an IDE (Investigational Device Exemption).'}}, 'adverseEventsModule': {'timeFrame': '12 weeks for distal radius fracture patients 0 weeks for healthy volunteers', 'description': 'Non-serious Adverse Event- An infection or bleeding in a patient as a result of their distal radius fracture plating surgery with Osteoprobe use.', 'eventGroups': [{'id': 'EG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Volunteers (Non Fracture Group)', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Osteoprobe Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Distal Radius Fracture Operative group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG002', 'title': 'Distal Radius Fracture Non-Operative Group', 'description': 'Distal Radius Fracture Non-Operative group patients will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}], 'classes': [{'title': 'High Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000', 'lowerLimit': '60.2', 'upperLimit': '79.8'}]}]}, {'title': 'Low Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '70.1', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': "Bone Material Strength index (BMSi)\n\nBy engaging the bone at 10 N and then delivering a single impact force of \\~40 N, the OsteoProbe records the maximum penetration depth of conical-spherical tip into cortical bone. This indentation distance increase (IDI) is indexed to the IDI acquired from a reference material immediately after the bone IDI measurements, such that the OsteoProbe-based measurement known as bone material strength index (BMSi) is 100 times IDI of reference material divided by IDI of the patient's bone. A lower BMSi measurement is the result of a higher indentation distance into the bone. For statistical analysis, we used the mean of the 10 BMSi measurements per case.", 'unitOfMeasure': 'Index', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only Distal Radius Fracture Operative Group subjects underwent Osteoprobe measurements where Bone Material Strength index (BMSi) was obtained.'}, {'type': 'PRIMARY', 'title': 'MRI Scan Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Distal Radius Fracture Operative Group subjects will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Distal Radius Fracture Non-operative Group subjects will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}], 'classes': [{'title': 'High Energy Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '9.51', 'upperLimit': '33'}]}]}, {'title': 'Low Energy Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '20.0'}]}]}, {'title': 'No fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG001', 'lowerLimit': '21.1', 'upperLimit': '30.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'Bound Water Fraction', 'unitOfMeasure': 'percentage of bound water fraction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Distal Radius Fracture Nonoperative Group- 2 subjects did not have MRI scan data.\n\nHealthy Volunteers- 1 subject did not take part in the MRI scan.\n\nDistal Radius Fracture Operative Group- 8 Low Energy and 6 high energy subjects did not take part in the MRI scan. 3 high energy subjects did not have usable MRI data due to technical issues.'}, {'type': 'PRIMARY', 'title': 'MRI Scan Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Distal Radius Fracture Operative Group subjects will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Distal Radius Fracture Non-operative Group subjects will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}], 'classes': [{'title': 'High Energy Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '1.86', 'upperLimit': '17.1'}]}]}, {'title': 'Low Energy Fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '22.7'}]}]}, {'title': 'No fracture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '12.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'Pore Water Fraction', 'unitOfMeasure': 'percentage of pore water fraction', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Distal Radius Fracture Nonoperative Group- 2 subjects did not have MRI scan data.\n\nHealthy Volunteers- 1 subject did not take part in the MRI scan.\n\nDistal Radius Fracture Operative Group- 8 Low Energy and 6 high energy subjects did not take part in the MRI scan. 3 high energy subjects did not have usable MRI data due to technical issues.'}, {'type': 'PRIMARY', 'title': 'DXA Scan Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Distal Radius Fracture Operative Group subjects will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Distal Radius Fracture Non-operative Group subjects will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}], 'classes': [{'title': 'High Energy- L1 -L4 VB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.119', 'groupId': 'OG000', 'lowerLimit': '1.022', 'upperLimit': '1.546'}, {'value': '1.475', 'groupId': 'OG002', 'lowerLimit': '1.022', 'upperLimit': '1.475'}]}]}, {'title': 'Low Energy- L1-L4 VB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.165', 'groupId': 'OG000', 'lowerLimit': '1.058', 'upperLimit': '1.322'}]}]}, {'title': 'No Fracture- L1-L4 VB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.138', 'groupId': 'OG001', 'lowerLimit': '0.908', 'upperLimit': '1.302'}]}]}, {'title': 'High Energy- Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.088', 'groupId': 'OG000', 'lowerLimit': '0.949', 'upperLimit': '1.213'}, {'value': '1.197', 'groupId': 'OG002', 'lowerLimit': '0.902', 'upperLimit': '1.197'}]}]}, {'title': 'Low Energy- Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.909', 'groupId': 'OG000', 'lowerLimit': '0.798', 'upperLimit': '1.024'}]}]}, {'title': 'No Fracture- Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.988', 'groupId': 'OG001', 'lowerLimit': '0.777', 'upperLimit': '1.140'}]}]}, {'title': 'High Energy- Femur neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.063', 'groupId': 'OG000', 'lowerLimit': '0.876', 'upperLimit': '1.167'}, {'value': '1.322', 'groupId': 'OG002', 'lowerLimit': '0.849', 'upperLimit': '1.322'}]}]}, {'title': 'Low Energy- Femur neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.920', 'groupId': 'OG000', 'lowerLimit': '0.825', 'upperLimit': '1.039'}]}]}, {'title': 'No fracture- Femur neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.008', 'groupId': 'OG001', 'lowerLimit': '0.753', 'upperLimit': '1.135'}]}]}, {'title': 'High Energy- Radius distal-third', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.938', 'groupId': 'OG000', 'lowerLimit': '0.754', 'upperLimit': '1.041'}, {'value': '1.059', 'groupId': 'OG002', 'lowerLimit': '0.851', 'upperLimit': '1.059'}]}]}, {'title': 'Low Energy- Radius distal-third', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.833', 'groupId': 'OG000', 'lowerLimit': '0.695', 'upperLimit': '0.958'}]}]}, {'title': 'No Fracture- Radius distal-third', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.887', 'groupId': 'OG001', 'lowerLimit': '0.683', 'upperLimit': '1.069'}]}]}, {'title': 'High Energy- Radius ultra-distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.924', 'groupId': 'OG000', 'lowerLimit': '0.743', 'upperLimit': '1.128'}, {'value': '1.071', 'groupId': 'OG002', 'lowerLimit': '0.837', 'upperLimit': '1.071'}]}]}, {'title': 'Low Energy- Radius ultra-distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.810', 'groupId': 'OG000', 'lowerLimit': '0.647', 'upperLimit': '0.908'}]}]}, {'title': 'No Fracture- Radius ultra-distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.883', 'groupId': 'OG001', 'lowerLimit': '0.761', 'upperLimit': '1.043'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'Bone Mineral Density', 'unitOfMeasure': 'g/cm^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Distal Radius Fracture Operative Group- Includes 9 high energy fracture and 14 low energy fracture subjects.\n\nHigh Energy: 1 did not have L1-L4 scanned, 2 did not receive calculations due to age. Low Energy- 3 did not have a DXA scan.\n\nHealthy Volunteers- 1 subject did not have a DXA scan.'}, {'type': 'PRIMARY', 'title': 'DXA Scan Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Distal Radius Fracture Operative Group subjects will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Distal Radius Fracture Non-operative Group subjects will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}], 'classes': [{'title': 'High Energy L1-L4 VB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '65.04', 'groupId': 'OG000', 'lowerLimit': '50.54', 'upperLimit': '101.70'}, {'value': '98.87', 'groupId': 'OG002', 'lowerLimit': '58.63', 'upperLimit': '98.87'}]}]}, {'title': 'Low Energy L1-L4 VB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.24', 'groupId': 'OG000', 'lowerLimit': '53.21', 'upperLimit': '74.61'}]}]}, {'title': 'No Fracture L1-L4 VB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70.19', 'groupId': 'OG001', 'lowerLimit': '47.86', 'upperLimit': '74.91'}]}]}, {'title': 'High Energy- Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.03', 'groupId': 'OG000', 'lowerLimit': '29.37', 'upperLimit': '47.17'}, {'value': '44.97', 'groupId': 'OG002', 'lowerLimit': '31.56', 'upperLimit': '44.97'}]}]}, {'title': 'Low Energy- Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '35.88'}]}]}, {'title': 'No Fracture- Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '36.97', 'groupId': 'OG001', 'lowerLimit': '22.43', 'upperLimit': '38.38'}]}]}, {'title': 'High Energy- Femur neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.05', 'groupId': 'OG000', 'lowerLimit': '4.32', 'upperLimit': '6.30'}, {'value': '7.26', 'groupId': 'OG002', 'lowerLimit': '4.58', 'upperLimit': '7.26'}]}]}, {'title': 'Low Energy- Femur neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.848', 'groupId': 'OG000', 'lowerLimit': '3.99', 'upperLimit': '5.05'}]}]}, {'title': 'No Fracture- Femur neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.49', 'groupId': 'OG001', 'lowerLimit': '3.73', 'upperLimit': '6.11'}]}]}, {'title': 'High Energy- Radius distal-third', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.07', 'groupId': 'OG000', 'lowerLimit': '1.76', 'upperLimit': '3.38'}, {'value': '3.64', 'groupId': 'OG002', 'lowerLimit': '2.09', 'upperLimit': '3.64'}]}]}, {'title': 'Low Energy- Radius distal-third', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.433', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '2.59'}]}]}, {'title': 'No Fracture- Radius distal-third', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.43', 'groupId': 'OG001', 'lowerLimit': '1.84', 'upperLimit': '2.57'}]}]}, {'title': 'High Energy- Radius ultra-distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.39', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '2.67'}, {'value': '2.43', 'groupId': 'OG002', 'lowerLimit': '1.64', 'upperLimit': '2.43'}]}]}, {'title': 'Low Energy- Radius ultra-distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.713', 'groupId': 'OG000', 'lowerLimit': '1.03', 'upperLimit': '1.96'}]}]}, {'title': 'No Fracture- Radius ultra-distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.87', 'groupId': 'OG001', 'lowerLimit': '1.23', 'upperLimit': '2.04'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'Bone Mineral Content', 'unitOfMeasure': 'g', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Distal Radius Fracture Operative Group- Includes 9 high energy fracture and 14 low energy fracture subjects.\n\nHigh Energy: 1 did not have L1-L4 scanned, 2 did not receive calculations due to age. Low Energy- 3 did not have a DXA scan.\n\nHealthy Volunteers- 1 subject did not have a DXA scan.'}, {'type': 'PRIMARY', 'title': 'DXA Scan Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Distal Radius Fracture Operative Group subjects will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Distal Radius Fracture Non-operative Group subjects will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}], 'classes': [{'title': 'High Energy- L1-L4 VB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '2.5'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '1.9'}]}]}, {'title': 'Low Energy- L1-L4 VB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '0.7'}]}]}, {'title': 'No Fracture- L1-L4 VB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-2.3', 'upperLimit': '0.6'}]}]}, {'title': 'High Energy- Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '1.6'}, {'value': '0.8', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '0.8'}]}]}, {'title': 'Low Energy- Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-0.1'}]}]}, {'title': 'No Fracture- Hip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '0.8'}]}]}, {'title': 'High Energy- Femur neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '1.4'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '-1.7', 'upperLimit': '1.9'}]}]}, {'title': 'Low Energy- Femur neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-1.5', 'upperLimit': '-0.2'}]}]}, {'title': 'No Fracture- Femur neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '-2.1', 'upperLimit': '0.5'}]}]}, {'title': 'High Energy- Radius distal-third', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '0.7'}, {'value': '0.7', 'groupId': 'OG002', 'lowerLimit': '-1.4', 'upperLimit': '0.7'}]}]}, {'title': 'Low Energy- Radius distal-third', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-2.1', 'upperLimit': '0.9'}]}]}, {'title': 'No Fracture- Radius distal-third', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '-2.2', 'upperLimit': '0.8'}]}]}, {'title': 'High Energy- Radius ultra-distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '3.9'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '-2.3', 'upperLimit': '1.3'}]}]}, {'title': 'Low Energy- Radius ultra-distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '-0.2'}]}]}, {'title': 'No Fracture- Radius ultra-distal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'A T-score is the number of standard deviations (SD) below (negative value) or above (positive value) the mean BMD (bone mineral density) for a healthy population. A person with T-score below -2.5 is considered to have osteoporosis.', 'unitOfMeasure': 't-score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Distal Radius Fracture Operative Group- Includes 7 high energy fracture and 14 low energy fracture subjects.\n\nHigh Energy: 1 did not have L1-L4 scanned, 2 did not receive calculations due to age. Low Energy- 3 did not have a DXA scan.\n\nHealthy Volunteers- 1 subject did not have a DXA scan.'}, {'type': 'SECONDARY', 'title': 'Patient-reported Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Distal Radius Fracture Operative Group subjects will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'OG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Distal Radius Fracture Non-operative Group subjects will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}], 'classes': [{'title': 'High Energy- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.18', 'spread': '28.08', 'groupId': 'OG000'}, {'value': '27.66', 'spread': '6.83', 'groupId': 'OG002'}]}]}, {'title': 'Low Energy- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.89', 'spread': '18.50', 'groupId': 'OG000'}]}]}, {'title': 'No Fracture- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'High Energy- 3 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '35.39', 'spread': '25.13', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '6.66', 'groupId': 'OG002'}]}]}, {'title': 'Low Energy- 3 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.73', 'spread': '18.85', 'groupId': 'OG000'}]}]}, {'title': 'High Energy- 6 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.43', 'spread': '24.46', 'groupId': 'OG000'}, {'value': '38.93', 'spread': '20.98', 'groupId': 'OG002'}]}]}, {'title': 'Low Energy- 6 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '38.93', 'spread': '20.98', 'groupId': 'OG000'}]}]}, {'title': 'High Energy- 12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.33', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.84', 'groupId': 'OG002'}]}]}, {'title': 'Low Energy- 12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '21.92', 'spread': '20.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks', 'description': 'DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. The score ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Distal Radius Fracture Operative Group- Includes 11 high energy fracture and 17 low energy fracture subjects.\n\nHealthy Volunteers were only asked to complete the DASH at the baseline visit.'}, {'type': 'SECONDARY', 'title': 'Patient-reported Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Distal Radius Fracture Operative Group subjects will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk MRI: Determines bound water and pore water of bone.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers will undergo DXA and MRI scans. Dual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk MRI: Determines bound water and pore water of bone.'}, {'id': 'OG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Distal Radius Fracture Non-operative Group subjects will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk MRI: Determines bound water and pore water of bone.'}], 'classes': [{'title': 'High Energy- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70.45', 'spread': '18.89', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '4.5', 'groupId': 'OG002'}]}]}, {'title': 'Low Energy- Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '76.30', 'spread': '16.85', 'groupId': 'OG000'}]}]}, {'title': 'High Energy- 3 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.44', 'spread': '27.04', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '7.5', 'groupId': 'OG002'}]}]}, {'title': 'Low Energy- 3 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.11', 'spread': '15.29', 'groupId': 'OG000'}]}]}, {'title': 'High Energy- 6 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '39.53', 'spread': '24.89', 'groupId': 'OG000'}, {'value': '10', 'spread': '6', 'groupId': 'OG002'}]}]}, {'title': 'Low Energy- 6 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.69', 'spread': '25.43', 'groupId': 'OG000'}]}]}, {'title': 'High Energy-12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.29', 'spread': '5.37', 'groupId': 'OG000'}, {'value': '2', 'spread': '2', 'groupId': 'OG002'}]}]}, {'title': 'Low Energy- 12 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '28.23', 'spread': '25.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Post-op/-treatment: 3, 6, and 12 weeks', 'description': 'PRWE (Patient-rated wrist evaluation) is a 15-item survey designed to measure wrist pain and disability in activities of daily living. The PRWE consists of a pain subscale and a function subscale. The pain subscale contains 5 items, each rated 0 (no pain) to 10 (worst pain ever). The pain subscale is calculated by adding all 5 item scores together (minimum score: 0, maximum score: 50). A lower score indicates a lower pain level. The function subscale contains 10 items, each rated 0 (no difficulty) to 10 (unable to do). The function subscale is calculated by adding all 10 item scores together and dividing by 2 (minimum score: 0, maximum score: 100). A lower score indicates a lower disability level. The total PRWE score is calculated by adding the pain and function subscales together. The total PRWE score ranges from 0 (best score) to 100 (worst score). The lower the score the better the outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only subjects with a fracture were asked to complete the PRWE survey. Distal Radius Fracture Operative Group- Includes 11 high energy fracture and 17 low energy fracture subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI (Reference Point Indentation): Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'FG001', 'title': 'Healthy Volunteers (Non Fracture Group)', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'FG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'High Energy Fracture', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Low Energy Fracture', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Excluded by MRI Screening', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Surgical Approach (Dorsal not volar)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Excluded due to other medical conditions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Distal Radius Fracture Operative Group', 'description': 'Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.\n\nOsteoprobe-RPI: Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'BG001', 'title': 'Healthy Volunteers (Non Fracture Group)', 'description': 'Healthy volunteers will undergo DXA and MRI scans.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'BG002', 'title': 'Distal Radius Fracture Non-operative Group', 'description': 'Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.\n\nDual-energy X-ray absorptiometry (DXA) Scans: Assessment of Fracture Risk\n\nMRI: Determines bound water and pore water of bone.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '76'}, {'value': '44', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '63'}, {'value': '30', 'groupId': 'BG002', 'lowerLimit': '25', 'upperLimit': '35'}, {'value': '40', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '76'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'BG000', 'lowerLimit': '17.2', 'upperLimit': '41.5'}, {'value': '27.55', 'groupId': 'BG001', 'lowerLimit': '18.16', 'upperLimit': '39.34'}, {'value': '25.61', 'groupId': 'BG002', 'lowerLimit': '22.07', 'upperLimit': '29.16'}, {'value': '27.7', 'groupId': 'BG003', 'lowerLimit': '17.2', 'upperLimit': '41.5'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'BMI unavailable for one subject in distal radius fracture operative group.'}], 'populationDescription': 'The Baseline Characteristics section does not include demographics data of 5 Distal Radius Operative Arm subjects, 1 Healthy Volunteer Arm subject and 2 Distal Radius Nonoperative Arm subjects. These subjects were withdrawn/lost to follow-up following consent, but prior to any study procedures taking place.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-08', 'size': 476380, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-30T10:55', 'hasProtocol': True}, {'date': '2020-05-14', 'size': 172665, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-14T15:03', 'hasProtocol': False}, {'date': '2015-09-24', 'size': 223578, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-17T11:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'FDA determined study device is significant risk. Study will not seek IDE.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2020-05-04', 'completionDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-12', 'studyFirstSubmitDate': '2015-04-24', 'dispFirstSubmitQcDate': '2020-05-14', 'resultsFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2015-05-01', 'dispFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-17', 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Osteoprobe Measurements', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': "Bone Material Strength index (BMSi)\n\nBy engaging the bone at 10 N and then delivering a single impact force of \\~40 N, the OsteoProbe records the maximum penetration depth of conical-spherical tip into cortical bone. This indentation distance increase (IDI) is indexed to the IDI acquired from a reference material immediately after the bone IDI measurements, such that the OsteoProbe-based measurement known as bone material strength index (BMSi) is 100 times IDI of reference material divided by IDI of the patient's bone. A lower BMSi measurement is the result of a higher indentation distance into the bone. For statistical analysis, we used the mean of the 10 BMSi measurements per case."}, {'measure': 'MRI Scan Measurements', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'Bound Water Fraction'}, {'measure': 'MRI Scan Measurements', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'Pore Water Fraction'}, {'measure': 'DXA Scan Measurements', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'Bone Mineral Density'}, {'measure': 'DXA Scan Measurements', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'Bone Mineral Content'}, {'measure': 'DXA Scan Measurements', 'timeFrame': 'Within a week before or after surgery to repair distal radius fracture', 'description': 'A T-score is the number of standard deviations (SD) below (negative value) or above (positive value) the mean BMD (bone mineral density) for a healthy population. A person with T-score below -2.5 is considered to have osteoporosis.'}], 'secondaryOutcomes': [{'measure': 'Patient-reported Measurements', 'timeFrame': 'Baseline/One-Time Completion and Post-op/-treatment: 3, 6, and 12 weeks', 'description': 'DASH (Disabilities of the Arm, Shoulder, and Hand) is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. The score ranges from 0 (no disability) to 100 (most severe disability). A higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability.'}, {'measure': 'Patient-reported Measurements', 'timeFrame': 'Baseline and Post-op/-treatment: 3, 6, and 12 weeks', 'description': 'PRWE (Patient-rated wrist evaluation) is a 15-item survey designed to measure wrist pain and disability in activities of daily living. The PRWE consists of a pain subscale and a function subscale. The pain subscale contains 5 items, each rated 0 (no pain) to 10 (worst pain ever). The pain subscale is calculated by adding all 5 item scores together (minimum score: 0, maximum score: 50). A lower score indicates a lower pain level. The function subscale contains 10 items, each rated 0 (no difficulty) to 10 (unable to do). The function subscale is calculated by adding all 10 item scores together and dividing by 2 (minimum score: 0, maximum score: 100). A lower score indicates a lower disability level. The total PRWE score is calculated by adding the pain and function subscales together. The total PRWE score ranges from 0 (best score) to 100 (worst score). The lower the score the better the outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Fracture Risk Assessment']}, 'descriptionModule': {'briefSummary': "The goal of this study is to determine whether two new, non-X-ray techniques can discriminate between high-energy fractures of normal bone (trauma) and low-energy fractures (fragility) of osteoporotic bone. The current gold-standard for assessing fracture risk areal bone mineral density (aBMD) by dual energy X-ray absorptiometry (DXA) is not particularly effective at identifying individuals who are at risk of suffering a fracture. Yet, there is a growing population of diabetics and elderly individuals prone to fractures. In effect, the age-related and diabetes-related increase in fracture risk is independent of a person's aBMD. These findings stress the urgency in developing diagnostic tools that can improve fracture risk prediction so that patients can be treated with the appropriate anti-fracture therapies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion/exclusion criteria for patients with a high-energy or fragility fracture requiring operative fixation (Arm 1)\n\nNumber of patients in Arm#1= 60 patients\n\nInclusion criteria:\n\n1. Patients who are 18 years of age or older. This age range accounts for 60% of all distal radius fractures seen at Vanderbilt University Medical Center.\n2. Patients who have sustained a low or high energy distal radius fracture that involves the metaphysis and requires open reduction internal fixation using volar plating.\n3. English speaking due to feasibility of employing study personnel to deliver and assess study intervention.\n\nExclusion criteria:\n\n1. Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)\n2. Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years\n3. Patients who have Type 1 diabetes\n4. Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)\n5. Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use\n6. Patients that would not be able to have a DXA scan (weight \\>350lbs, hardware in hips, patients that have lap band device)\n7. Patients who are pregnant or who think they may be pregnant\n8. Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)\n9. Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements\n10. Patients who have distal radial shaft fractures\n\nExclusion criteria 1-5 are included because the goal of the study is to demonstrate whether new bone measurements differentiate normal bone from fragile bone. These exclusion criteria eliminate confounding factors that affect fracture resistance of bone in ways that are independent of osteoporosis. Exclusion criteria 6-8 are practical since DXA/MRI scans cannot accommodate all people.\n\nInclusion/exclusion criteria for patients with no fracture (Arm 2)\n\nNumber of patients in Arm#2= 40 patients\n\nInclusion criteria:\n\n1. Patients who are 18 years of age or older.\n2. Patients who have no history of fracture or family history of pathologic fracture\n3. English speaking due to feasibility of employing study personnel to deliver and assess study intervention.\n\nExclusion criteria:\n\n1. Patients who are taking medication to treat osteoporosis (e.g. bisphosphonate)\n2. Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years\n3. Patients who have Type 1 diabetes\n4. Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism).\n5. Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use.\n6. Patients that would not be able to have a DXA scan (weight \\>350lbs, hardware in hips, patients that have lap band device)\n7. Patients who are pregnant or who think they may be pregnant.\n8. Patients that have a medical contraindication to MRI.\n\nExclusion criteria 1-5 are included because the goal of the study is to demonstrate whether new bone measurements differentiate normal bone from fragile bone. These exclusion criteria eliminate confounding factors that affect fracture resistance of bone in ways that are independent of osteoporosis. Exclusion criteria 6- 8 are practical since DXA/MRI scans cannot accommodate all people.\n\nInclusion/exclusion criteria for patients with a high-energy or fragility fracture requiring nonoperative treatment (Arm 3)\n\nNumber of patients in Arm#3= up to 10 patients\n\nInclusion criteria:\n\n1. Patients who are 18 years of age or older. This age range accounts for 60% of all distal radius fractures seen at Vanderbilt University Medical Center.\n2. Patients who have sustained a low or high energy distal radius fracture that requires nonoperative treatment\n3. English speaking due to feasibility of employing study personnel to deliver and assess study intervention.\n\nExclusion criteria:\n\n1. Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)\n2. Patients who have or are receiving treatment for osteoporosis (e.g. bisphosphonate) lasted longer than 5 years\n3. Patients who have Type 1 diabetes\n4. Patients who have other bone disease (e.g., osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)\n5. Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use\n6. Patients that would not be able to have a DXA scan (weight \\>350lbs, hardware in hips, patients that have lap band device)\n7. Patients who are pregnant or who think they may be pregnant\n8. Patients that have a medical contraindication to MRI (if patients are undergoing a study MRI)\n9. Patients who have concurrent, bilateral upper extremity fractures where hardware or casting may affect study scan measurements\n\nExclusion criteria 1-5 are included because the goal of the study is to demonstrate whether new bone measurements differentiate normal bone from fragile bone. These exclusion criteria eliminate confounding factors that affect fracture resistance of bone in ways that are independent of osteoporosis. Exclusion criteria 6-8 are practical since DXA/MRI scans cannot accommodate all people."}, 'identificationModule': {'nctId': 'NCT02436356', 'briefTitle': 'New Tools for Assessing Fracture Risk', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'New Tools for Assessing Fracture Risk', 'orgStudyIdInfo': {'id': '141125'}, 'secondaryIdInfos': [{'id': 'UL1TR000445', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR000445', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Distal Radius Fracture Operative Group', 'description': 'Fracture group patients will undergo DXA and MRI scans, along with Osteoprobe indentation.', 'interventionNames': ['Device: Osteoprobe-Reference Point Indentation (RPI)', 'Radiation: Dual-energy X-ray absorptiometry (DXA) Scans', 'Radiation: MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Volunteers (Non Fracture Group)', 'description': 'Healthy volunteers will undergo DXA and MRI scans.', 'interventionNames': ['Radiation: Dual-energy X-ray absorptiometry (DXA) Scans', 'Radiation: MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Distal Radius Fracture Non-operative Group', 'description': 'Fracture group patients will undergo DXA and MRI scans, but will not undergo Osteoprobe indentation.', 'interventionNames': ['Radiation: Dual-energy X-ray absorptiometry (DXA) Scans', 'Radiation: MRI']}], 'interventions': [{'name': 'Osteoprobe-Reference Point Indentation (RPI)', 'type': 'DEVICE', 'description': 'Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).', 'armGroupLabels': ['Distal Radius Fracture Operative Group']}, {'name': 'Dual-energy X-ray absorptiometry (DXA) Scans', 'type': 'RADIATION', 'description': 'Assessment of Fracture Risk', 'armGroupLabels': ['Distal Radius Fracture Non-operative Group', 'Distal Radius Fracture Operative Group', 'Healthy Volunteers (Non Fracture Group)']}, {'name': 'MRI', 'type': 'RADIATION', 'description': 'Determines bound water and pore water of bone.', 'armGroupLabels': ['Distal Radius Fracture Non-operative Group', 'Distal Radius Fracture Operative Group', 'Healthy Volunteers (Non Fracture Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Univeristy Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Jeffry S Nyman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No current plant to share individual participant data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ActiveLife Scientific', 'class': 'INDUSTRY'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Orthopaedics and Rehabilitation', 'investigatorFullName': 'Jeffry Nyman', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}