Pilot Study of Fosamax in Spinal Cord Injury

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2012

Detailed Description

The project was funded on August 13, 2009 and was awarded to one of our trainees, Dr. Matthew Abraham, a PGY3 in our program and our IRB approval was obtained with much time and effort on February 24, 2010. We followed the protocol and so far we recruited just one patient on September 19, 2011 who completed the study but we encountered with many unexpected obstacles to recruit any more patients to the study. The main obstacle was that the spine surgeons' refusal to start the study drug for months after surgery for fear of complications with wound healing. Secondly, the few appropriate and eligible patients we tried to recruit declined to participate. We were unable to recruit any more patients to this study and hence the study was closed. The one patient that was recruited completed the study. Since it is only one subject in the study, no conclusions can be drawn.

Interventions

  • Drug: Fosamax
    • 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
  • Drug: Placebo
    • Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo.

Arms, Groups and Cohorts

  • Active Comparator: Fosamax
    • Fosamax at 70 mgs q weekly by mouth for the duration of the study.
  • Placebo Comparator: Placebo Sugar Pill
    • Double blind study using Fosamax versus placebo. Placebo is an inactive drug.

Clinical Trial Outcome Measures

Primary Measures

  • Bone Mineral Density
    • Time Frame: 1 year after enrollment
    • Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Rochester
  • Provider of Information About this Clinical Study
    • Principal Investigator: K. R Poduri, Chair of Department of PM&R – University of Rochester
  • Overall Official(s)
    • Kanakadurga R Poduri, M.D., Principal Investigator, University of Rochester

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