Pilot Study of Fosamax in Spinal Cord Injury

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01131884
• Other study ID #: U of R 29563
• Status: Terminated
• Phase: N/A
• First received: May 25, 2010
• Last updated: December 25, 2015
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: December 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Fosamax
70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
• 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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York
United States	University of Rochester Physical Medicine and Rehabilitation	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density	Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis	1 year after enrollment	No