Investigator left the institution

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

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

All individual participant data (IPD) collected during the trial that underlies published results will be shared, including de-identified data on demographic variables, dual-energy X-ray absorptiometry (DXA) bone mineral density (BMD) measurements, Hounsfield unit (HU) values from CT scans, L3 skeletal muscle index, radiographic fusion outcomes, hardware complication data, and patient-reported outcomes (ODI and VAS scores). Data will be made available to other qualified researchers upon reasonable request following publication of primary results, contingent on IRB approval and data use agreements.

IPD and supporting information will be available beginning 12 months after publication of the primary results and will remain available for 5 years thereafter.

Qualified researchers with a methodologically sound proposal may request access to the data by contacting the study principal investigator. Requestors will need to complete a data use agreement. Data will be provided via a secure online platform after IRB approval and review of the request by the study team.