The Efficacy of Denosumab to Prevent Bone Loss in Ambulatory and Non-ambulatory Motor-Incomplete Patients With Subacute Spinal Cord Injury

Who is this study for? Adult patients age 18 to 65 with spinal cord injury
What treatments are being studied? Denosumab�
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to determine the usefulness of a drug, denosumab, to prevent the loss of bone in participants legs due to SCI. This drug is FDA approved to treat osteoporosis in women after menopause who have an increased risk for fractures, to treat women receiving certain treatments for breast cancer who have an increased risk of fractures, and to treat bone loss in men receiving certain treatments for prostate cancer who have increased risk for fractures. This drug is considered experimental for the purpose of this study. Study participation will last for approximately 12 months (6 study visits total), visits will range from1-4.5 hours depending on the number of tests that need to be completed. The study is a double-blinded placebo trail in which the participant will be randomly assigned to on of two groups, Denosumab injections or placebo - inactive salt solution injections.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: No
View:

• Motor incomplete SCI [American Spinal Injury Association Impairment Scale (AIS) grades C and D];

• Duration of injury < 6-months; and

• Males between the ages of 18 and 65 years old and females between the ages of 18 and 50 years old.

Locations
United States
New Jersey
Kessler Institute for Rehabilitation
Not yet recruiting
West Orange
New York
James J. Peters VA Medical Center
Recruiting
Bronx
Contact Information
Primary
Christopher M Cirnigliaro, M.S.
christopher.cirnigliaro@va.gov
973-731-3900
Backup
William A Bauman, M.D.
william.bauman@va.gov
718-584-9000
Time Frame
Start Date: April 1, 2017
Estimated Completion Date: December 2023
Participants
Target number of participants: 32
Treatments
Experimental: Denosumab, AIS Grade C (non-ambulatory)
8 subjects with AIS grade C will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.
Placebo Comparator: Placebo, AIS Grade C (non-ambulatory)
8 subjects with AIS grade C will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.
Experimental: Denosumab, AIS Grade D (ambulatory)
8 subjects with AIS grade D will be randomized to receive Denosumab (Prolia 120mg SC) administered at baseline and 6 months.
Placebo Comparator: Placebo, AIS Grade D (ambulatory)
8 subjects with AIS grade D will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.
Authors
Christopher M Cirniliaro, Steven C Kirshblum, William A Bauman
Sponsors
Leads: James J. Peters Veterans Affairs Medical Center
Collaborators: Kessler Institute for Rehabilitation

This content was sourced from clinicaltrials.gov

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