Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-28 @ 3:25 AM
Study NCT ID:
NCT00138866
Status:
COMPLETED
Last Update Posted:
2010-10-13
First Post:
2005-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], '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'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068296', 'term': 'Risedronic Acid'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-12', 'studyFirstSubmitDate': '2005-08-29', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bone mineral density of the distal femur between baseline and 18-months', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Change in bone mineral density of the hips and proximal tibia between baseline and 18-months', 'timeFrame': '18 months'}, {'measure': 'The change in biochemical bone markers of bone turnover between baseline and 18-months', 'timeFrame': '18 months'}, {'measure': 'The frequency and severity of adverse events', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal cord injury'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Traumatic spinal cord injury of greater than 18 months\n* Osteopenia or osteoporosis of the hip\n* Must be able to swallow tablets and sit upright\n\nExclusion Criteria:\n\n* Bilateral heterotopic ossification\n* Bilateral lower extremity metal implants\n* Pregnant or lactating females\n* Paget's disease\n* Osteomalacia\n* Steroid induced bone loss\n* Untreated parathyroid or thyroid disease\n* Symptomatic hypocalcemia or hypophosphatemia\n* Treatment in the last year with calcitonin, fluoride or anabolic steroids\n* Current treatment with prednisone"}, 'identificationModule': {'nctId': 'NCT00138866', 'briefTitle': 'Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Toronto Rehabilitation Institute'}, 'officialTitle': 'Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'TRI REB #04-016'}, 'secondaryIdInfos': [{'id': 'PSI #03-52'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Risedronate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4G 3V9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Rehab, Lyndhurst Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'B. Cathy Craven, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto Rehabilitation Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toronto Rehabilitation Institute', 'class': 'OTHER'}, 'collaborators': [{'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}, {'name': "St. Joseph's Health Care London", 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. BC Craven', 'oldOrganization': 'Toronto Rehab Institute'}}}}