Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.

Phase 3

Completed

• Conditions: Acute Spinal Cord Injury.

• Registration Number: NCT00150696
• Lead Sponsor: Toronto Rehabilitation Institute

Brief Summary

The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-08
• Study Completion: 2005-11
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-20
• Last Update Posted: 2007-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Hamilton Health Sciences, Chedoke Site; 🇨🇦 Hamilton, Ontario, Canada

Toronto Rehab, Lyndhurst Centre; 🇨🇦 Toronto, Ontario, Canada