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

October 12, 2010 updated by: Toronto Rehabilitation Institute

Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4G 3V9
        • Toronto Rehab, Lyndhurst Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in bone mineral density of the distal femur between baseline and 18-months
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in bone mineral density of the hips and proximal tibia between baseline and 18-months
Time Frame: 18 months
18 months
The change in biochemical bone markers of bone turnover between baseline and 18-months
Time Frame: 18 months
18 months
The frequency and severity of adverse events
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toronto Rehabilitation Institute

Collaborators

The Physicians' Services Incorporated Foundation
St. Joseph's Health Care London

Investigators

  • Principal Investigator: B. Cathy Craven, MD, FRCPC, Toronto Rehabilitation Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

October 13, 2010

Last Update Submitted That Met QC Criteria

October 12, 2010

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRI REB #04-016
  • PSI #03-52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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