NCT06973109WithdrawnPhase 2
Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
Investigating the Efficacy of Romosozumab in Augmenting Bone Density and Muscle Mass to Enhance the Outcomes of Spine Surgery
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Reason given: Investigator left the institution
Brief summary (registry, in English)
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
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 2 May 2025
- Start date
- 20 Jun 2026
- Primary completion date
- 2 Mar 2027
- Lead sponsor
- University of Pittsburgh
- Diseases
- Osteoporosis
- NCT number
- NCT06973109
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior spinal surgery.
- Current or prior use of osteoporosis medications within the past 3 years.
- Current use of androgen receptor (AR) modulators, such as testosterone replacement therapy or selective androgen receptor modulators (SARMs).
Other illness
- Known hypersensitivity to romosozumab, alendronate or zoledronic acid.
- Active malignancy or history of malignancy within the past 5 years.
- Stroke or myocardial infarction in the past year.
Lab values
- Severe renal impairment (eGFR < 30 mL/min/1.73m²).
Other
- Male sex.
- Current use of anabolic agents other than romosozumab.
- Severe spinal deformity.
- Any secondary cause of decreased BMD (e.g., hyperparathyroidism).
- Planned fusion involving more than 4 levels.
- Uncorrected hypocalcemia and/or hypovitaminosis D
- Esophageal abnormalities
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.