Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.
This study has been completed.
Sponsor:
Toronto Rehabilitation Institute
Collaborators:
Ontario Neurotrauma Foundation
St. Joseph's Healthcare Foundation
Queen Elizabeth Hospital Foundation
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00150696
First received: September 6, 2005
Last updated: November 20, 2007
Last verified: November 2007
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Purpose
The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.
Condition | Intervention | Phase |
---|---|---|
Acute Spinal Cord Injury. |
Drug: Risedronate |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
Official Title: | Risedronate for Prevention of Osteoporosis After Spinal Cord Injury |
Resource links provided by NLM:
Further study details as provided by Toronto Rehabilitation Institute:
Primary Outcome Measures:
- Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.
Secondary Outcome Measures:
- Change in bone mineral density of the total body, spine and femoral neck between baseline, 12-months and 24-months.
- Change in biochemical markers of bone turnover between baseline, 12-months and 24-months.
- Frequency and severity of adverse events.
- Quality of life.
Estimated Enrollment: | 38 |
Study Start Date: | February 2000 |
Estimated Study Completion Date: | November 2005 |
Eligibility
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Traumatic spinal cord injury less than 100 days.
- Must be able to swallow tablets and sit upright.
Exclusion Criteria:
- Bilateral knee flexion contractures.
- Pregnant, lactating or post-menopausal females.
- Paget's disease, osteomalacia, steroid induced bone loss, untreated thyroid disease, iritis, uveitis, pancreatitis, gastritis, peptic ulcer or cholecystitis.
- Treatment in the last year with calcitonin, fluoride or anabolic steroid.
- Concurrent treatment with prednisone.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150696
Locations
Canada, Ontario | |
Hamilton Health Sciences, Chedoke Site | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Toronto Rehab, Lyndhurst Centre | |
Toronto, Ontario, Canada, M4G 3V9 |
Sponsors and Collaborators
Toronto Rehabilitation Institute
Ontario Neurotrauma Foundation
St. Joseph's Healthcare Foundation
Queen Elizabeth Hospital Foundation
Investigators
Principal Investigator: | B. Cathy Craven, MD, FRCPC | Toronto Rehabilitation Institute |
More Information
No publications provided
Keywords provided by Toronto Rehabilitation Institute:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00150696 History of Changes |
Other Study ID Numbers: | TRI REB #02-040, ONRO-79 |
Study First Received: | September 6, 2005 |
Last Updated: | November 20, 2007 |
Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Toronto Rehabilitation Institute:
Osteoporosis Spinal Cord Injury |
Additional relevant MeSH terms:
Osteoporosis Spinal Cord Injuries Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
Risedronic acid Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 16, 2012