Not Yet RecruitingPhase 2

Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes

United States36 participantsStarted 2026-03-20

Plain-language 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 questions it aims to answer are: * Does romosozumab improve bone strength and reduce the risk of complications during and after spine surgery? * Does romosozumab increase muscle mass and help patients recover better from surgery? Researchers will compare romosozumab (a monthly injection) to alendronate (a weekly pill), both approved treatments for osteoporosis, to see which is more effective in this surgical setting. Participants will: * Be randomly assigned to receive romosozumab or alendronate * Take standard vitamin supplements and receive a one-time dose of zoledronic acid near the end of the study * Attend five study visits over about 12 months * Undergo bone scans, muscle imaging, and complete health questionnaires before and after surgery

Who can participate

Age range65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Change in Hounsfield Units (HU) at L1 Vertebra

Timeframe: Baseline, 3 months post-op, and 9 months post-op

Change in Vertebral Bone Mineral Density (BMD) at L1

Timeframe: Baseline, 3 months post-op, and 9 months post-op

Trial details

NCT IDNCT06973109

SponsorNitin Agarwal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-02

Contact for this trial

Rohit Prem Kumar, M.D.

609-613-3465 kumarrp@upmc.edu