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

Osteoporosis Clinical Trial

Official title:

Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138866
• Other study ID #: TRI REB #04-016
• Secondary ID: PSI #03-52
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: October 12, 2010
• Start date: November 2004
• Est. completion date: March 2009

Study information

• Verified date: July 2008
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Spinal Cord Injuries

Intervention

Drug:
• Risedronate

Locations

Country	Name	City	State
Canada	Toronto Rehab, Lyndhurst Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	St. Joseph's Health Care London, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone mineral density of the distal femur between baseline and 18-months		18 months	No
Secondary	Change in bone mineral density of the hips and proximal tibia between baseline and 18-months		18 months	No
Secondary	The change in biochemical bone markers of bone turnover between baseline and 18-months		18 months	No
Secondary	The frequency and severity of adverse events		18 months	Yes