Treatment With Romosozumab Versus Denosumab to Improve Bone Mineral Density and Architecture in Subacute SCI

Who is this study for? Patients with Osteoporosis, Spinal Cord Injuries
What treatments are being studied? Denosumab
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The objective of the proposed work is to determine whether administration for 12 months of romosozumab followed by 12 months of denosumab will maintain bone mass at the knee in subjects with subacute SCI compared to 24 months of denosumab administration alone.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: No
View:

• Traumatic motor-complete SCI C4-L2 (AIS grade A & B);

• Duration of SCI less than 6 months;

• Males and females (premenopausal) between the ages of 18 and 50 years old; and a safe range of BMD right above the knee as determined by study staff review;

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, Ph.D
christopher.cirnigliaro@va.gov
973-731-3900
Backup
William A Bauman, M.D.
william.bauman@va.gov
718-584-9000
Time Frame
Start Date: November 1, 2021
Estimated Completion Date: November 1, 2027
Participants
Target number of participants: 40
Treatments
Experimental: Romosozumab Baseline to Month 11 followed by Denosumab Month 12 to Month 24
Of the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive romosozumab (210mg SQ) once a month for 12 months.~After 12 months the same twenty (20) individuals will receive denosumab (60mg SQ) at month 12 and 18.
Active Comparator: Denosumab Baseline to Month 24
Of the forty (40) individuals with subacute spinal cord injury (SCI) enrolled in this study, twenty (20) participants will be randomly selected to receive denosumab (60 mg SQ) at baseline and 6, 12, and 18 months.
Authors
Steven C Kirshblum, 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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