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
|
