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

This study has been completed.

First Received: September 6, 2005 Last Updated: November 20, 2007 History of Changes

Sponsors and Collaborators:	Toronto Rehabilitation Institute Ontario Neurotrauma Foundation St. Joseph's Healthcare Foundation Queen Elizabeth Hospital Foundation
Information provided by:	Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:	NCT00150696

Purpose

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

Condition	Intervention	Phase
Acute Spinal Cord Injury.	Drug: Risedronate	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Risedronate for Prevention of Osteoporosis After Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Minerals Osteoporosis Spinal Cord Injuries

Drug Information available for: Risedronic acid Risedronate sodium

U.S. FDA Resources

Further study details as provided by Toronto Rehabilitation Institute:

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.

Estimated Enrollment:	38
Study Start Date:	February 2000
Estimated Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150696

Locations

Canada, Ontario
Toronto Rehab, Lyndhurst Centre
Toronto, Ontario, Canada, M4G 3V9
Hamilton Health Sciences, Chedoke Site
Hamilton, Ontario, Canada, L8N 3Z5

Sponsors and Collaborators

Toronto Rehabilitation Institute

Ontario Neurotrauma Foundation

St. Joseph's Healthcare Foundation

Queen Elizabeth Hospital Foundation

Investigators

Principal Investigator:

B. Cathy Craven, MD, FRCPC

Toronto Rehabilitation Institute

More Information

No publications provided

Study ID Numbers:	TRI REB #02-040, ONRO-79
Study First Received:	September 6, 2005
Last Updated:	November 20, 2007
ClinicalTrials.gov Identifier:	NCT00150696 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Toronto Rehabilitation Institute:

Osteoporosis
Spinal Cord Injury

Study placed in the following topic categories:

Spinal Cord Diseases
Wounds and Injuries
Calcium Channel Blockers
Osteoporosis
Central Nervous System Diseases
Disorders of Environmental Origin
Bone Diseases, Metabolic
Bone Density Conservation Agents

Cardiovascular Agents
Trauma, Nervous System
Bone Diseases
Spinal Cord Injuries
Calcium, Dietary
Musculoskeletal Diseases
Risedronic acid

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Spinal Cord Diseases
Physiological Effects of Drugs
Nervous System Diseases
Wounds and Injuries
Calcium Channel Blockers
Osteoporosis
Central Nervous System Diseases
Disorders of Environmental Origin
Bone Diseases, Metabolic

Bone Density Conservation Agents
Cardiovascular Agents
Trauma, Nervous System
Bone Diseases
Pharmacologic Actions
Membrane Transport Modulators
Spinal Cord Injuries
Musculoskeletal Diseases
Therapeutic Uses
Risedronic acid

ClinicalTrials.gov processed this record on August 30, 2009