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

Toronto Rehabilitation Institute

Status and phase: Completed; Phase 3

Conditions: Acute Spinal Cord Injury.

Treatments: Drug: Risedronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00150696

ONRO-79

TRI REB #02-040

Details and patient eligibility

About

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

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind