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
Spinal Cord Injury Osteoporosis	Drug: Risedronate	Phase III

Further Study Details: 

Primary Outcomes: Change in bone mineral density of the distal femur between baseline and 18-months.
Secondary Outcomes: 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.
Expected Total Enrollment:  44

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  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 steroid
• Current treatment with prednisone

Please refer to this study by ClinicalTrials.gov identifier  NCT00138866

J. Michelle Kinsey, BPHE      416-597-3422  Ext. 6301    kinsey.jacqueline@torontorehab.on.ca

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

Study chairs or principal investigators

B. Cathy Craven, MD, FRCPC,  Principal Investigator,  Toronto Rehabilitation Institute   

Study ID Numbers:  TRI REB #04-016; PSI #03-52
Last Updated:  August 29, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00138866
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-30