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Pilot Study of Fosamax in Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Osteoporosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fosamax
Placebo
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring ASIA A or ASIA B Spinal Cord Injury

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester Physical Medicine and Rehabilitation
  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fosamax

Placebo Sugar Pill

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 25, 2010
Last Updated
December 25, 2015
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT01131884
Brief Title
Pilot Study of Fosamax in Spinal Cord Injury
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 Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Terminated
Why Stopped
Only 1 participant enrolled since the beginning of this study
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Osteoporosis
Keywords
ASIA A or ASIA B Spinal Cord Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fosamax
Arm Type
Active Comparator
Arm Description
Fosamax at 70 mgs q weekly by mouth for the duration of the study.
Arm Title
Placebo Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Double blind study using Fosamax versus placebo. Placebo is an inactive drug.
Intervention Type
Drug
Intervention Name(s)
Fosamax
Other Intervention Name(s)
Alendronate sodiuum
Intervention Description
70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone Mineral Density
Description
Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis
Time Frame
1 year after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanakadurga R Poduri, M.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Physical Medicine and Rehabilitation
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Pilot Study of Fosamax in Spinal Cord Injury

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