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

• Sponsor: Toronto Rehabilitation Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00138866
• Collaborator: The Physicians' Services Incorporated Foundation (Other), St. Joseph's Health Care London (Other)
• Enrollment: 46
• Location: 1
• Duration (Months): 51.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Risedronate	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Outcome Measures

Primary Outcome Measures

1. Change in bone mineral density of the distal femur between baseline and 18-months [18 months]

Secondary Outcome Measures

1. Change in bone mineral density of the hips and proximal tibia between baseline and 18-months [18 months]

2. The change in biochemical bone markers of bone turnover between baseline and 18-months [18 months]

3. The frequency and severity of adverse events [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Rehab, Lyndhurst Centre	Toronto	Ontario	Canada	M4G 3V9

Sponsors and Collaborators

• Toronto Rehabilitation Institute
• The Physicians' Services Incorporated Foundation
• St. Joseph's Health Care London

Investigators

• Principal Investigator: B. Cathy Craven, MD, FRCPC, Toronto Rehabilitation Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00138866
• Other Study ID Numbers: TRI REB #04-016; PSI #03-52
• First Posted: Aug 30, 2005
• Last Update Posted: Oct 13, 2010
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: Spinal cord injury
• Additional relevant MeSH terms: Osteoporosis; Spinal Cord Injuries; Risedronic Acid

Study Results

No Results Posted as of Oct 13, 2010