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

Primary Purpose

Osteoporosis

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Risedronate

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Spinal cord injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Toronto Rehab, Lyndhurst Centre

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

The frequency and severity of adverse events

Full Information

NCT ID

NCT00138866

First Posted

August 29, 2005

Last Updated

October 12, 2010

Sponsor

Toronto Rehabilitation Institute

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00138866

Brief Title

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

Official Title

Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Toronto Rehabilitation Institute

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

Keywords

Spinal cord injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Risedronate

Primary Outcome Measure Information:

Title

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

Time Frame

18 months

Secondary Outcome Measure Information:

Title

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

Time Frame

18 months

Title

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

Time Frame

18 months

Title

The frequency and severity of adverse events

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

B. Cathy Craven, MD, FRCPC

Organizational Affiliation

Toronto Rehabilitation Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto Rehab, Lyndhurst Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4G 3V9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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