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

This study has been completed.
Sponsor:
Collaborators:
Ontario Neurotrauma Foundation
St. Joseph's Healthcare Foundation
Queen Elizabeth Hospital Foundation
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00150696
First received: September 6, 2005
Last updated: November 20, 2007
Last verified: November 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Risedronate for Prevention of Osteoporosis After Spinal Cord Injury

Resource links provided by NLM:

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

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

Keywords provided by Toronto Rehabilitation Institute:
Osteoporosis
Spinal Cord Injury

Additional relevant MeSH terms:
Osteoporosis
Spinal Cord Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
 Risedronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013