Pilot Study of Fosamax in Spinal Cord Injury

University of Rochester

Status: Terminated

Conditions: Osteoporosis; Spinal Cord Injury

Treatments: Drug: Placebo; Drug: Fosamax

Study type: Interventional

Funder types: Other

Identifiers

NCT01131884

U of R 29563

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1 participants in 2 patient groups, including a placebo group

Fosamax

Active Comparator group

Description:

Fosamax at 70 mgs q weekly by mouth for the duration of the study.

Treatment:

Drug: Fosamax

Placebo Sugar Pill

Placebo Comparator group

Description:

Double blind study using Fosamax versus placebo. Placebo is an inactive drug.

Treatment:

Drug: Placebo