Effects of Romosozumab on Bone Health in Women With Spinal Cord Injury and Osteoporosis
Overview
- Phase
- Phase 2
- Intervention
- Romosozumab
- Conditions
- Osteoporosis
- Sponsor
- Northwestern University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Integral vBMC at the Knee (Distal Femur)
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
This two-year open-label pilot clinical trial will evaluate the efficacy and safety of romosozumab to treat bone loss in females with chronic spinal cord injury (SCI) and osteoporosis (OP). Participants will receive monthly injections of romosozumab during the first 12 months of the study. During the second year, participants will take oral alendronate tablets on a weekly basis.
Detailed Description
This is a single-site, singe-arm, open-label pilot study to evaluate safety and efficacy of a sequential drug treatment (12 months of romosozumab injections followed by 12 months with alendronate tablets) to treat bone loss in women with chronic SCI and OP. During the first year, participants will receive monthly subcutaneous injections of romosozumab 210 mg. This drug works by increasing bone formation and is FDA-approved for treating OP in post-menopausal women at high risk of fracture or those who did not benefit from using other available OP treatments. During the second year, participants will take weekly oral alendronate 70 mg. Alendronate is FDA-approved for the treatment of osteopenia and the treatment of OP in post-menopausal women and men as well as for the prevention and treatment of glucocorticoid-induced OP. In this study, it will be used to help maintain any increases in bone mass gained from the year of treatment with romosozumab. Twelve participants will receive the study drug treatment, take daily supplements (calcium and vitamin D), and return to the research site for study visits over the course of two years. Computerized tomography (CT) imaging, dual-energy X-ray absorptiometry (DXA) imaging, and serum bone markers will be collected at various time points.
Investigators
Thomas J. Schnitzer
Professor
Northwestern University
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years
- •Female sex
- •SCI 6 or more months prior to enrollment
- •Non-ambulatory status (Walking Index for Spinal Cord Injury II score of 3 or less)
- •Osteoporosis by DXA defined as a t-score of -2.5 at any skeletal site (lumbar spine, total hip, or femoral neck) or a t-score of -2.0 plus a history of a fragility fracture
- •Good general health, as determined by the study investigator
- •Able to understand and agree to informed consent in English
- •Able and willing to complete all the study visits
- •Females of childbearing potential must be willing and able to use an effective method of contraception or practice abstinence throughout the course of the study and up to 90 days after the last use of study drug.
- •Vitamin D 25-hydroxy levels ≥ 20 ng/ml (subjects may be repleted and retested prior to baseline)
Exclusion Criteria
- Not provided
Arms & Interventions
Females with Chronic SCI
12-month treatment with monthly subcutaneous romosozumab injections (210 mg), followed by 12-month treatment with weekly oral alendronate tablets (70 mg)
Intervention: Romosozumab
Females with Chronic SCI
12-month treatment with monthly subcutaneous romosozumab injections (210 mg), followed by 12-month treatment with weekly oral alendronate tablets (70 mg)
Intervention: Alendronate
Outcomes
Primary Outcomes
Change in Integral vBMC at the Knee (Distal Femur)
Time Frame: Baseline - 12 months
Change from baseline to the Month 12 visit in volumetric bone mineral content (vBMC) obtained via CT (three-dimensional) imaging of the knee.
Secondary Outcomes
- Change in BMD at the Total Hip and Femoral Neck(Baseline - 12 months)
- Change in vBMC at the Hip(Baseline - 12 months)
- Change in Serum Bone Biomarkers (CTX and P1NP)(Baseline - 12 months)