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Pilot Study of Fosamax in Spinal Cord Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Rochester.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT01131884
First received: May 25, 2010
Last updated: March 11, 2011
Last verified: March 2011
History of Changes
  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:

U.S. FDA Resources

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


Estimated Enrollment: 10
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fosamax Drug: Fosamax
70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
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.

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

Contacts
Contact: Kanakadurga R Poduri, MD (585) 275-3274 KR_Poduri@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Mathew J Abraham, MD     585-275-3274     mathew_abraham@urmc.rochester.edu    
Sub-Investigator: Mathew J Abraham, MD            
Principal Investigator: Kanakadurga R Poduri, MD            
Sponsors and Collaborators
University of Rochester
  More Information

No publications provided

Responsible Party: Kananadurga Poduri, University of Rochester
ClinicalTrials.gov Identifier: NCT01131884     History of Changes
Other Study ID Numbers: U of R 29563
Study First Received: May 25, 2010
Last Updated: March 11, 2011
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, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013