Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-16 @ 7:20 PM
Study NCT ID:
NCT00682357
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2008-05-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'HLINDSLE@kumc.edu', 'phone': '(913) 588-3402', 'title': 'Dr. Herbert Lindsley', 'organization': 'University of Kansas Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1 - Standard Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2 - Low Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3 - Placebo', 'description': 'Placebo and Lidocaine: Placebo and lidocaine 20 mg', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum Osteocalcin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Standard Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg'}, {'id': 'OG001', 'title': 'Group 2 - Low Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg'}, {'id': 'OG002', 'title': 'Group 3 - Placebo', 'description': 'Placebo and Lidocaine: Placebo and lidocaine 20 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.18', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '2.90', 'groupId': 'OG001'}, {'value': '-1.10', 'spread': '2.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline Visit to Day 28', 'description': 'Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Standard Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg'}, {'id': 'OG001', 'title': 'Group 2 - Low Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg'}, {'id': 'OG002', 'title': 'Group 3 - Placebo', 'description': 'Placebo and Lidocaine: Placebo and lidocaine 20 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.153', 'spread': '0.457', 'groupId': 'OG000'}, {'value': '-0.295', 'spread': '0.472', 'groupId': 'OG001'}, {'value': '-0.148', 'spread': '0.804', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline Visit to Day 28', 'description': 'Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Standard Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg'}, {'id': 'OG001', 'title': 'Group 2 - Low Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg'}, {'id': 'OG002', 'title': 'Group 3 - Placebo', 'description': 'Placebo and Lidocaine: Placebo and lidocaine 20 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline Visit to Day 28', 'description': 'Outcome represents the mean change in testosterone level from baseline visit to day 28.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only males randomized to Group 1 - Standard Dose were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Cortisol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 - Standard Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg'}, {'id': 'OG001', 'title': 'Group 2 - Low Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg'}, {'id': 'OG002', 'title': 'Group 3 - Placebo', 'description': 'Placebo and Lidocaine: Placebo and lidocaine 20 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.16', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '4.59', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '1.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline Visit to Day 28', 'description': 'Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.', 'unitOfMeasure': 'mcg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 - Standard Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg'}, {'id': 'FG001', 'title': 'Group 2 - Low Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg'}, {'id': 'FG002', 'title': 'Group 3 - Placebo', 'description': 'Placebo and Lidocaine: Placebo and lidocaine 20 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 - Standard Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg'}, {'id': 'BG001', 'title': 'Group 2 - Low Dose', 'description': 'Methylprednisolone and Lidocaine: Methylprednisolone 16 mg intra-articular and lidocaine 20 mg'}, {'id': 'BG002', 'title': 'Group 3 - Placebo', 'description': 'Placebo and Lidocaine: Placebo and lidocaine 20 mg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2008-05-20', 'resultsFirstSubmitDate': '2016-10-05', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-05', 'studyFirstPostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Osteocalcin', 'timeFrame': 'Change from Baseline Visit to Day 28', 'description': 'Change in serum markers of bone formation (osteocalcin) from Day 0 to Day 28.'}, {'measure': 'Change in Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b)', 'timeFrame': 'Change from Baseline Visit to Day 28', 'description': 'Outcome represents the mean change in serum biomarkers of bone breakdown (TRACP-5b) from baseline visit to day 28.'}], 'secondaryOutcomes': [{'measure': 'Change in Testosterone', 'timeFrame': 'Change from Baseline Visit to Day 28', 'description': 'Outcome represents the mean change in testosterone level from baseline visit to day 28.'}, {'measure': 'Change in Serum Cortisol', 'timeFrame': 'Change from Baseline Visit to Day 28', 'description': 'Cortisol levels were measured over 28 days. Outcome represents mean change in cortisol level between baseline visit and day 28.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis, intra articular steroids'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis.', 'detailedDescription': 'Oral and nasal steroids may enhance osteoporosis by suppressing bone formation. Intra-articular steroids may also suppress bone formation, however, the duration or relationship to a steroid dose has not been established. It is hypothesized that intra-articular steroids suppress bone formation transiently, returning to pretreatment levels within four weeks in subjects with osteoarthritis. The purpose of the study is to determine if intra-articular steroids suppress markers of bone formation or resorption in osteoarthritis patients and whether these markers may be modified by Vitamin D or Dual-energy X-ray absorptiometry (DEXA) bone density status'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 40 years\n* Male or postmenopausal female\n* Diagnosis of knee osteoarthritis\n* DEXA bone density done within the past 12 months\n* Painful knee, visual analogue scale (VAS) \\> 4 of (10=worst)\n\nExclusion Criteria:\n\n* Diabetes Mellitus Type I or II\n* Systemic inflammatory illness\n* Systemic infections which may be aggravated by steroid therapy\n* No current or previous (\\< 3 years) biphosphate therapy\n* Previous knee replacement surgery\n* No current or previous Parathyroid hormone (PTH) therapy'}, 'identificationModule': {'nctId': 'NCT00682357', 'briefTitle': 'Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Effect of Intraarticular Steroids on Bone Turnover in Osteoarthritis', 'orgStudyIdInfo': {'id': '11199'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Methylprednisone 80 mg and Lidocaine 20 mg', 'interventionNames': ['Drug: Methylprednisolone and Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Methylprednisolone 16 mg and Lidocaine 20 mg', 'interventionNames': ['Drug: Methylprednisolone and Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo and Lidocaine 20 mg', 'interventionNames': ['Drug: Placebo and Lidocaine']}], 'interventions': [{'name': 'Methylprednisolone and Lidocaine', 'type': 'DRUG', 'description': 'Methylprednisolone 80 mg, intra-articular and lidocaine 20 mg', 'armGroupLabels': ['1']}, {'name': 'Methylprednisolone and Lidocaine', 'type': 'DRUG', 'description': 'Methylprednisolone 16 mg intra-articular and lidocaine 20 mg', 'armGroupLabels': ['2']}, {'name': 'Placebo and Lidocaine', 'type': 'DRUG', 'description': 'Placebo and lidocaine 20 mg', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Herbert Lindsley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}