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

This study has been completed.
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
St. Joseph's Health Care London
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00138866
First received: August 29, 2005
Last updated: October 12, 2010
Last verified: July 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoporosis
 Drug: Risedronate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Risedronate for Treatment of Sublesional 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 between baseline and 18-months [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in bone mineral density of the hips and proximal tibia between baseline and 18-months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • The change in biochemical bone markers of bone turnover between baseline and 18-months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • The frequency and severity of adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 46
Study Start Date: November 2004
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138866

Locations
Canada, Ontario
Toronto Rehab, Lyndhurst Centre
Toronto, Ontario, Canada, M4G 3V9
Sponsors and Collaborators
Toronto Rehabilitation Institute
The Physicians' Services Incorporated Foundation
St. Joseph's Health Care London
Investigators
Principal Investigator: B. Cathy Craven, MD, FRCPC Toronto Rehabilitation Institute
  More Information

No publications provided

Responsible Party: Dr. BC Craven, Toronto Rehab Institute
ClinicalTrials.gov Identifier: NCT00138866     History of Changes
Other Study ID Numbers: TRI REB #04-016, PSI #03-52
Study First Received: August 29, 2005
Last Updated: October 12, 2010
Health Authority: Canada: Health Canada

Keywords provided by Toronto Rehabilitation Institute:
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 23, 2013