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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2005-11-30

Brief Summary

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

Detailed Description

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Conditions

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Acute Spinal Cord Injury.

Keywords

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Osteoporosis Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Risedronate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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B. Cathy Craven, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute

Locations

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Hamilton Health Sciences, Chedoke Site

Hamilton, Ontario, Canada

Site Status

Toronto Rehab, Lyndhurst Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ONRO-79

Identifier Type: -

Identifier Source: secondary_id

TRI REB #02-040