Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury

Phase 3

Completed

• Conditions: Osteoporosis

• Registration Number: NCT00138866
• Lead Sponsor: Toronto Rehabilitation Institute

Brief Summary

The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Status Verified: 2008-07
• Primary Completion: 2009-01
• Study Completion: 2009-03
• Last Update Submitted: 2010-10-12
• Last Update Posted: 2010-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Traumatic spinal cord injury of greater than 18 months
• Osteopenia or osteoporosis of the hip
• Must be able to swallow tablets and sit upright

Exclusion Criteria

• Bilateral heterotopic ossification
• Bilateral lower extremity metal implants
• Pregnant or lactating females
• Paget's disease
• Osteomalacia
• Steroid induced bone loss
• Untreated parathyroid or thyroid disease
• Symptomatic hypocalcemia or hypophosphatemia
• Treatment in the last year with calcitonin, fluoride or anabolic steroids
• Current 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 between baseline and 18-months	18 months

Secondary Outcome Measures

Name	Time	Method
Change in bone mineral density of the hips and proximal tibia between baseline and 18-months	18 months
The change in biochemical bone markers of bone turnover between baseline and 18-months	18 months
The frequency and severity of adverse events	18 months

Trial Locations

Locations (1)

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