Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes (NCT06973109) | Clinical Trial Compass
WithdrawnPhase 2
Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
Stopped: Investigator left the institution
United States0Started 2026-06-20
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 range
65 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hounsfield Units (HU) at L1 Vertebra
Timeframe: Baseline, 3 months post-op, and 9 months post-op
2
Change in Vertebral Bone Mineral Density (BMD) at L1
Timeframe: Baseline, 3 months post-op, and 9 months post-op