Pilot Study of Fosamax in Spinal Cord Injury
Information source: University of Rochester
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spinal Cord Injury; Osteoporosis
Intervention: Fosamax (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Rochester Overall contact:
Kanakadurga R Poduri, MD, Phone: (585) 275-3274, Email: KR_Poduri@urmc.rochester.edu
Summary
Study is designed to evaluate the efficacy of oral fosamax in prevention on osteoporosis in
acute spinal cord injury. Efficacy will be measured by a duel energy X-Ray absorptiometry
(DEXA) scan every 6 months. Patients will complete 3 visits, screening, 6 months, 12 months
and be required to take oral fosamax versus placebo weekly.
Clinical Details
Official title: Double Blind Placebo Controlled Trial to Evaluate Preservation of Bone Mineral Density of the Hip and Distal Femur by Biphosphate Therapy (Fosamax) Following Spinal Cord Injury
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Bone Mineral Density
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- American Spinal Cord Injury Association (ASIA) A or American Spinal Cord Injury
Association (ASIA) B Spinal Cord Injury
Exclusion Criteria:
- History of hypersensitivity to alendronate or other bisphosphonates
- esophageal abnormality
- inability to sit/stand upright for 30 minutes
- creatinine clearance less than 35 milliliters/minute
- hypothyroidism
- malignancy
- pregnancy
- prolonged steroid use
Locations and Contacts
Kanakadurga R Poduri, MD, Phone: (585) 275-3274, Email: KR_Poduri@urmc.rochester.edu
University of Rochester, Rochester, New York 14642, United States; Recruiting
Mathew J Abraham, MD, Phone: 585-275-3274, Email: mathew_abraham@urmc.rochester.edu
Mathew J Abraham, MD, Sub-Investigator
Kanakadurga R Poduri, MD, Principal Investigator
Additional Information
Starting date: June 2010
Last updated: March 11, 2011
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