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

Toronto Rehabilitation Institute46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoporosis

Interventions

RisedronateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Toronto Rehab, Lyndhurst Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Change in bone mineral density of the distal femur between baseline and 18-months

Time frame: 18 months

Secondary Outcomes

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

Time frame: 18 months

The change in biochemical bone markers of bone turnover between baseline and 18-months

Time frame: 18 months

The frequency and severity of adverse events

Time frame: 18 months

Data from ClinicalTrials.gov

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