Treatment With Romosozumab to Improve Bone Mineral Density and Architecture in Chronic 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 (evenity) followed by 12 months of denosumab (prolia) will maintain bone mass at the knee in subjects with chronic SCI.

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

• Motor complete or incomplete SCI C4 and below {upper motor lesions; International Standards for Neurological Classification of Spinal Cord Injury (ISNSCI) grade A-C (wheelchair dependent greater than 75% of the time)

• Duration of SCI between 3-15 years;

• Males and females (premenopausal) between the ages of 18 and 50 years old (the upper age limit is to reduce the influence of age on the ability of the skeleton to respond to pharmacologic stimulation);

• aBMD at the distal femur greater than or equal to 0.6 g/cm2 but less than or equal to 1.0 g/cm2;

• Agreement to use a highly effective contraceptive method for women of reproductive potential.

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 Cirnigliaro, PhD
christopher.cirnigliaro@va.gov
973-731-3900
Time Frame
Start Date: March 1, 2021
Estimated Completion Date: March 1, 2027
Participants
Target number of participants: 39
Treatments
Experimental: Romosozumab group
Romosozumab (evenity) administered monthly from baseline to month 11 followed by denosumab (prolia) at month 12 and 18
Placebo Comparator: Control group
Placebo administered monthly from baseline to month 11 followed by denosumab (prolia) at month 12 and 18
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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