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Risedronate for the Prevention of Osteoporosis in 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: Acute Spinal Cord Injury.

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 to prevent osteoporosis after spinal cord injury.

Clinical Details

Official title: Risedronate for Prevention of Osteoporosis After Spinal Cord Injury

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Primary outcome: Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.

Secondary outcome:

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.

Eligibility

Minimum age: 16 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

Hamilton Health Sciences, Chedoke Site, Hamilton, Ontario L8N 3Z5, Canada

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

Additional Information

Starting date: February 2000
Last updated: November 20, 2007

Page last updated: August 20, 2015

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