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

Primary Purpose

Acute Spinal Cord Injury.

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Risedronate

About this trial

This is an interventional prevention trial for Acute Spinal Cord Injury. focused on measuring Osteoporosis, Spinal Cord Injury

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hamilton Health Sciences, Chedoke Site
Toronto Rehab, Lyndhurst Centre

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00150696

First Posted

September 6, 2005

Last Updated

November 20, 2007

Sponsor

Toronto Rehabilitation Institute

Collaborators

Ontario Neurotrauma Foundation, St. Joseph's Healthcare Foundation, Queen Elizabeth Hospital NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT00150696

Brief Title

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

Official Title

Risedronate for Prevention of Osteoporosis After Spinal Cord Injury

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

February 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Toronto Rehabilitation Institute

Collaborators

Ontario Neurotrauma Foundation, St. Joseph's Healthcare Foundation, Queen Elizabeth Hospital NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

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

Acute Spinal Cord Injury.

Keywords

Osteoporosis, Spinal Cord Injury

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

38 (false)

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 and proximal tibia between baseline, 12-months and 24-months.

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Frequency and severity of adverse events.

Title

Quality of life.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

60 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

Hamilton Health Sciences, Chedoke Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 3Z5

Country

Canada

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 Prevention of Osteoporosis in People With Spinal Cord Injury.

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