Status:
NOT_YET_RECRUITING
Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
Lead Sponsor:
Nitin Agarwal
Collaborating Sponsors:
Amgen
Beckwith Foundation
Conditions:
Osteoporosis, Post-menopausal
Eligibility:
FEMALE
65+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to learn if romosozumab (Evenity) can improve bone and muscle health in postmenopausal women with osteoporosis who are undergoing lumbar spine surgery. The main ques...
Eligibility Criteria
Inclusion
- Post-menopausal female
- Diagnosed with osteoporosis (T-score ≤ -2.5).
- Scheduled for or planning posterior lumbar fusion for degenerative disease, at least 3 months in the future.
- Able to provide informed consent.
Exclusion
- History of prior spinal surgery.
- Male sex.
- Current or prior use of osteoporosis medications within the past 3 years.
- Current use of anabolic agents other than romosozumab.
- Current use of androgen receptor (AR) modulators, such as testosterone replacement therapy or selective androgen receptor modulators (SARMs).
- Severe renal impairment (eGFR \< 30 mL/min/1.73m²).
- Known hypersensitivity to romosozumab, alendronate or zoledronic acid.
- Severe spinal deformity.
- Active malignancy or history of malignancy within the past 5 years.
- Any secondary cause of decreased BMD (e.g., hyperparathyroidism).
- Stroke or myocardial infarction in the past year.
- Planned fusion involving more than 4 levels.
- Uncorrected hypocalcemia and/or hypovitaminosis D
- Esophageal abnormalities
Key Trial Info
Start Date :
January 26 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06973109
Start Date
January 26 2026
End Date
June 1 2027
Last Update
January 8 2026
Active Locations (1)
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1
University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213