The Efficacy of Denosumab to Reduce Osteoporosis After Spinal Cord Injury

Who is this study for? Adult patients with Osteoporosis
What treatments are being studied? Denosumab
Status: Unknown status
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Sublesional bone loss after acute spinal cord injury (SCI) is sudden, progressive, and dramatic. After depletion of bone mass and the loss of architectural integrity, it may be difficult, if even possible, to restore skeletal mass and strength. Denosumab is a relative new, highly potent anti-resorptive agent that has proven efficacy in postmenopausal osteoporosis to improve bone mass and in solid tumor patients to prevent a skeletal-related event to a greater extent than that with bisphosphonate administration. In persons with complete motor lesions, bisphosphonates have not been effective at reducing bone loss at the knee, the site of greatest relevance because of its increased risk of fracture. Anti-RANKL therapy appears to be more potent than bisphosphonates in animal models of bone loss due to immobilization, suggesting that treatment with denosumab may prove to be an efficacious therapy for persons with acute SCI to preserve bone mass and strength.

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

• Complete motor SCI [American Spinal Injury Association Impairment Scale (AIS) grade A and B];

• Duration of injury <12 weeks; 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
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: January 2015
Completion Date: May 2020
Participants
Target number of participants: 24
Treatments
Placebo Comparator: Placebo
A group of participants will be randomized to the placebo group and will receive the identical volume of normal saline at parallel time points.
Experimental: Denosumab
A group of participants will be randomized to the experimental group and will have Denosumab (Prolia, 60 mg SC) administered at baseline, 6 and 12 months.
Authors
Steven C Kirshblum, William A Bauman, Christopher M Cirnigliaro
Related Therapeutic Areas
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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