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Pilot Study of Fosamax in Spinal Cord Injury

This study has been terminated.
(Only 1 participant enrolled since the beginning of this study)
Sponsor:
Information provided by (Responsible Party):
K. R Poduri, University of Rochester
ClinicalTrials.gov Identifier:
NCT01131884
First received: May 25, 2010
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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 Intervention
Spinal Cord Injury
Osteoporosis
Drug: Fosamax
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: No ]
    Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis


Enrollment: 1
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131884

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
University of Rochester Physical Medicine and Rehabilitation
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

No publications provided

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
Study First Received: May 25, 2010
Results First Received: December 4, 2012
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
ASIA A or ASIA B Spinal Cord Injury

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

ClinicalTrials.gov processed this record on November 24, 2014