Pilot Study of Fosamax in Spinal Cord Injury

NCT01131884 | Terminated Results

• 1 other identifier: U of R 29563
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injury; Osteoporosis

Keywords

ASIA A or ASIA B Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Bone Mineral Density

  Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis

  1 year after enrollment

Study Arms (2)

Fosamax

ACTIVE COMPARATOR

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

Drug: Fosamax

Placebo Sugar Pill

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Fosamax DRUG

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

Also known as: Alendronate sodiuum

Fosamax

Placebo 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.

Also known as: Sugar pill

Placebo Sugar Pill

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Spinal Cord Injury Association (ASIA) A or American Spinal Cord Injury Association (ASIA) B Spinal Cord Injury

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (2)

University of Rochester Physical Medicine and Rehabilitation

Rochester, New York, 14642, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Osteoporosis

Interventions

Alendronate; Sugars

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: K.Rao Poduri, M.D., Chair of Physical Medicine & Rehab
• Organization: University of Rochester

kr_poduri@urmc.rochester.edu

585-275-6978

Study Officials

• Kanakadurga R Poduri, M.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of PM&R

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: May 27, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 29, 2016
• Results First Posted: September 16, 2013

Record last verified: 2015-12

Locations

US (2)