Pilot Study of Fosamax in Spinal Cord Injury

NCT ID: NCT01131884

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Fosamax

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

Group Type: ACTIVE_COMPARATOR

Fosamax

Intervention Type: DRUG

70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year

Placebo Sugar Pill

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

Fosamax

70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Alendronate sodiuum; Sugar pill

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

K. R Poduri

Chair of Department of PM&R

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kanakadurga R Poduri, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Physical Medicine and Rehabilitation

Rochester, New York, United States

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

U of R 29563

Identifier Type: -

Identifier Source: org_study_id