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

Acute Spinal Cord Injury. Clinical Trial

Official title:

Risedronate for Prevention of Osteoporosis After Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150696
• Other study ID #: TRI REB #02-040
• Secondary ID: ONRO-79
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: November 20, 2007
• Start date: February 2000
• Est. completion date: November 2005

Study information

• Verified date: November 2007
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Spinal Cord Injury.
• Osteoporosis
• Spinal Cord Injuries

Intervention

Drug:
• Risedronate

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences, Chedoke Site	Hamilton	Ontario
Canada	Toronto Rehab, Lyndhurst Centre	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	Ontario Neurotrauma Foundation, Queen Elizabeth Hospital NHS Foundation Trust, St. Joseph's Healthcare 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 and proximal tibia between baseline, 12-months and 24-months.
Secondary	Change in bone mineral density of the total body, spine and femoral neck between baseline, 12-months and 24-months.
Secondary	Change in biochemical markers of bone turnover between baseline, 12-months and 24-months.
Secondary	Frequency and severity of adverse events.
Secondary	Quality of life.