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

Toronto Rehabilitation Institute

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: Risedronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00138866

PSI #03-52

TRI REB #04-016

Details and patient eligibility

About

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

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind