NCT01131884

Pilot Study of Fosamax in Spinal Cord Injury

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury
• Osteoporosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-05-27
• Last updated: 2016-01-29
• Results posted: 2013-09-16

Locations

2 sites across 1 country: United States