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

Phase 3CompletedNCT00150696

Toronto Rehabilitation Institute38 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Acute Spinal Cord Injury.

Interventions

RisedronateDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (2)

Hamilton Health Sciences, Chedoke Site

Hamilton, Ontario, Canada

Toronto Rehab, Lyndhurst Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.

Secondary Outcomes

Change in bone mineral density of the total body, spine and femoral neck between baseline, 12-months and 24-months.

Change in biochemical markers of bone turnover between baseline, 12-months and 24-months.

Frequency and severity of adverse events.

Quality of life.

Data from ClinicalTrials.gov

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