Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-13 @ 10:07 PM
Study NCT ID:
NCT02155595
Status:
COMPLETED
Last Update Posted:
2019-03-29
First Post:
2014-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Bone \\& serum to be retained per institutional guidelines and clinical practice'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 738}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-28', 'studyFirstSubmitDate': '2014-01-29', 'studyFirstSubmitQcDate': '2014-06-02', 'lastUpdatePostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Osteocyte lacunae', 'timeFrame': '5 years', 'description': 'Determine the prevalence of osteocyte lacunae. In BP treated patients with Severely Suppressed Bone Turnover (SSBT), PBD, or AFF, or with none of these complications, determine the prevalence of osteocyte lacunae in osteonal and interstitial iliac cortical bone'}], 'primaryOutcomes': [{'measure': 'Prodromal bone deterioration (PBD)', 'timeFrame': '5 years', 'description': 'Determine the prevalence of PBD and/or Atypical Femoral Fractures (AFF) in patients with post-menopausal or glucocorticoid related osteoporosis, either treated with bisphosphonate (BP) for more than 2 years or never treated with a BP'}], 'secondaryOutcomes': [{'measure': 'Diagnosis of PBD', 'timeFrame': '5 years', 'description': 'Refine diagnostic criteria for the diagnosis of PBD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoporosis', 'Atypical Femoral Fractures', 'Prodromal Bone Deterioration']}, 'referencesModule': {'references': [{'pmid': '33434290', 'type': 'DERIVED', 'citation': 'Farlay D, Rizzo S, Ste-Marie LG, Michou L, Morin SN, Qiu S, Chavassieux P, Chapurlat RD, Rao SD, Brown JP, Boivin G. Duration-Dependent Increase of Human Bone Matrix Mineralization in Long-Term Bisphosphonate Users with Atypical Femur Fracture. J Bone Miner Res. 2021 Jun;36(6):1031-1041. doi: 10.1002/jbmr.4244. Epub 2021 Feb 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this protocol is to determine the risk of atypical femoral shaft (thigh bone) fractures after long term fracture prevention therapy with a class of drugs called "bisphosphonates", colloquially referred to as Alendronate, risedronate, Ibandronate, and Zoledronate.\n\nIn addition, the study is designed to find out which patient is most likely to develop this potential life changing complication and why. Finally, the results of this study will help clinicians to better understand the reason and thus tailor patient specific treatments…i.e., "the right treatment for the right patient for right duration."'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be found within the Henry Ford Health System Division of Endocrinology, Diabetes, Bone \\& Mineral Disorders', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with a diagnosis of osteopenia or osteoporosis as defined by Bone Mineral density (BMD)\n* patient treated with BPs for \\>5 years\n* patients treated with non-BP anti-fracture medications such as...\n* estrogens, raloxifene, calcitonin\n* treatment naive patients\n\nExclusion Criteria:\n\n* all men regardless of BMD result\n* patients with obvious traumatic AFF\n* patients with normal BMD (better than -1.0 T-score at spine or proximal hip)\n* unable to take tetracycline\n* previous use of teriparatide\n* known allergies to the following:\n* tetracycline antibiotics\n* meperidine\n* midazolam'}, 'identificationModule': {'nctId': 'NCT02155595', 'acronym': 'NIH fracture', 'briefTitle': 'Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Pathogenesis of Atypical Femur Fractures on Long Term Bisphosphonate Therapy', 'orgStudyIdInfo': {'id': '1R01AR062103-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01AR062103-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'label': '500 with BP treatment', 'description': 'patients will undergo lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)', 'interventionNames': ['Other: 500 with BP treatment']}, {'label': '500 without BP treatment', 'description': 'patients will undergo lab tests, X-ray, bone scan or MRI, as needed', 'interventionNames': ['Other: 500 without BP treatment']}], 'interventions': [{'name': '500 without BP treatment', 'type': 'OTHER', 'description': 'lab tests, X-ray, bone scan or MRI, as needed', 'armGroupLabels': ['500 without BP treatment']}, {'name': '500 with BP treatment', 'type': 'OTHER', 'description': 'lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)', 'armGroupLabels': ['500 with BP treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Medical Center, New Center One', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Sudhaker D. Rao, M.B;B.S.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior staff physician', 'investigatorFullName': 'Sudhaker D Rao, MD', 'investigatorAffiliation': 'Henry Ford Health System'}}}}