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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150696
First Posted: September 8, 2005
Last Update Posted: November 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ontario Neurotrauma Foundation
St. Joseph's Healthcare Foundation
Queen Elizabeth Hospital NHS Foundation Trust
Information provided by:
Toronto Rehabilitation Institute
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Risedronate for Prevention of Osteoporosis After Spinal Cord Injury

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 NHS Foundation Trust
Investigators
Principal Investigator: B. Cathy Craven, MD, FRCPC Toronto Rehabilitation Institute
  More Information

ClinicalTrials.gov Identifier: NCT00150696     History of Changes
Other Study ID Numbers: TRI REB #02-040
ONRO-79
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: November 21, 2007
Last Verified: November 2007

Keywords provided by Toronto Rehabilitation Institute:
Osteoporosis
Spinal Cord Injury

Additional relevant MeSH terms:
Wounds and Injuries
Osteoporosis
Spinal Cord Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs