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Pilot Study of Fosamax in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01131884
Recruitment Status : Terminated (Only 1 participant enrolled since the beginning of this study)
First Posted : May 27, 2010
Results First Posted : September 16, 2013
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Spinal Cord Injury Osteoporosis Drug: Fosamax Drug: Placebo

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : June 2010
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Fosamax
Fosamax at 70 mgs q weekly by mouth for the duration of the study.
Drug: Fosamax
70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
Other Name: Alendronate sodiuum
Placebo Comparator: Placebo Sugar Pill
Double blind study using Fosamax versus placebo. Placebo is an inactive drug.
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.
Other Name: Sugar pill


Outcome Measures

Primary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: 1 year after enrollment ]
    Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131884


Locations
United States, New York
University of Rochester Physical Medicine and Rehabilitation
Rochester, New York, United States, 14642
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Kanakadurga R Poduri, M.D. University of Rochester
More Information

Responsible Party: K. R Poduri, Chair of Department of PM&R, University of Rochester
ClinicalTrials.gov Identifier: NCT01131884     History of Changes
Other Study ID Numbers: U of R 29563
First Posted: May 27, 2010    Key Record Dates
Results First Posted: September 16, 2013
Last Update Posted: January 29, 2016
Last Verified: December 2015

Keywords provided by K. R Poduri, University of Rochester:
ASIA A or ASIA B Spinal Cord Injury

Additional relevant MeSH terms:
Wounds and Injuries
Osteoporosis
Spinal Cord Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs