Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.
Information source: Toronto Rehabilitation Institute
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Spinal Cord Injury.
Intervention: Risedronate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Toronto Rehabilitation Institute Official(s) and/or principal investigator(s): B. Cathy Craven, MD, FRCPC, Principal Investigator, Affiliation: Toronto Rehabilitation Institute
Summary
The purpose of this study is to find out if Risedronate works to prevent osteoporosis after
spinal cord injury.
Clinical Details
Official title: Risedronate for Prevention of Osteoporosis After Spinal Cord Injury
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.
Secondary outcome: 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.
Eligibility
Minimum age: 16 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Hamilton Health Sciences, Chedoke Site, Hamilton, Ontario L8N 3Z5, Canada
Toronto Rehab, Lyndhurst Centre, Toronto, Ontario M4G 3V9, Canada
Additional Information
Starting date: February 2000
Last updated: November 20, 2007
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