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

Information source: Toronto Rehabilitation Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Risedronate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Toronto Rehabilitation Institute

Official(s) and/or principal investigator(s):
B. Cathy Craven, MD, FRCPC, Principal Investigator, Affiliation: Toronto Rehabilitation Institute

Summary

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

Clinical Details

Official title: Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in bone mineral density of the distal femur between baseline and 18-months

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Toronto Rehab, Lyndhurst Centre, Toronto, Ontario M4G 3V9, Canada
Additional Information

Starting date: November 2004
Last updated: October 12, 2010

Page last updated: August 20, 2015

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