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Pilot Study of Fosamax in Spinal Cord Injury

Not Applicable
Terminated
Conditions
Spinal Cord Injury
Osteoporosis
Interventions
Drug: Fosamax
Drug: Placebo
Registration Number
NCT01131884
Lead Sponsor
University of Rochester
Brief 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.

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1
Inclusion Criteria
  • American Spinal Cord Injury Association (ASIA) A or American Spinal Cord Injury Association (ASIA) B Spinal Cord Injury
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
FosamaxFosamaxFosamax at 70 mgs q weekly by mouth for the duration of the study.
Placebo Sugar PillPlaceboDouble blind study using Fosamax versus placebo. Placebo is an inactive drug.
Primary Outcome Measures
NameTimeMethod
Bone Mineral Density1 year after enrollment

Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

University of Rochester

🇺🇸

Rochester, New York, United States

University of Rochester Physical Medicine and Rehabilitation

🇺🇸

Rochester, New York, United States

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