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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

August 29, 2005
October 12, 2010
November 2004
January 2009   (final data collection date for primary outcome measure)
Change in bone mineral density of the distal femur between baseline and 18-months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Change in bone mineral density of the distal femur between baseline and 18-months.
Complete list of historical versions of study NCT00138866 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in bone mineral density of the hips and proximal tibia between baseline and 18-months.
  • The change in biochemical bone markers of bone turnover between baseline and 18-months.
  • The frequency and severity of adverse events.
Not Provided
Not Provided
 
Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury
Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury

The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
Drug: Risedronate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00138866
TRI REB #04-016, PSI #03-52
Yes
Dr. BC Craven, Toronto Rehab Institute
Toronto Rehabilitation Institute
  • The Physicians' Services Incorporated Foundation
  • St. Joseph's Health Care London
Principal Investigator: B. Cathy Craven, MD, FRCPC Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP