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Pilot Study of Fosamax in Spinal Cord Injury

Information source: University of Rochester
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spinal Cord Injury; Osteoporosis

Intervention: Fosamax (Drug); Placebo (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Kanakadurga R Poduri, M.D., Principal Investigator, Affiliation: University of Rochester

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

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.

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

University of Rochester, Rochester, New York 14642, United States

University of Rochester Physical Medicine and Rehabilitation, Rochester, New York 14642, United States

Additional Information

Starting date: June 2010
Last updated: September 12, 2013

Page last updated: August 20, 2015

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