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

NCT06973109 — Phase 2, Withdrawn, University of Pittsburgh

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Investigating the Efficacy of Romosozumab in Augmenting Bone Density and Muscle Mass to Enhance the Outcomes of Spine Surgery

Registry	NCT06973109
Status	Withdrawn - Investigator left the institution
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Sponsor	University of Pittsburgh (Other); collaborators: Amgen, The Greg Beckwith Foundation
Conditions	Osteoporosis, Post-menopausal
Interventions	Romosozumab, Alendronate (Fosamax), Placebo Romosozumab, Placebo Alendronate (Drug)
Dates	start 2026-06-20 (estimated), primary completion 2027-03-02 (estimated), completion 2027-06-01 (estimated), first posted 2025-05-15, last updated 2026-06-04
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Romosozumab + Placebo Alendronate	Experimental	Drug: Romosozumab; Drug: Placebo Alendronate	Participants will receive monthly subcutaneous injections of romosozumab (210 mg, one injection per arm) for 12 months, along with weekly oral placebo alendronate. Surgery will be performed 3 months after treatment initiation. DXA and CT scans will assess bone density and muscle mass. Functional outcomes will be evaluated via PROMs at baseline and follow-up.
Alendronate + Placebo Romosozumab	Active comparator	Drug: Alendronate (Fosamax); Drug: Placebo Romosozumab	Participants will receive weekly oral doses of alendronate (70 mg) and monthly subcutaneous placebo injections mimicking romosozumab. Surgery will occur after 3 months of treatment. Bone density, muscle mass, and functional outcomes will be assessed similarly to the experimental arm.

Romosozumab (Drug), also known as Evenity: Monthly subcutaneous injection (210 mg total dose) administered as two separate 105 mg injections, one per arm. Administered for 12 months to female patients ≥65 years undergoing spine surgery.
Alendronate (Fosamax) (Drug), also known as Fosamax: Weekly oral dose (70 mg) administered for 12 months. Used as active comparator in control arm of study.
Placebo Romosozumab (Drug): Monthly subcutaneous injections mimicking romosozumab in appearance and administration schedule. Administered to control group.
Placebo Alendronate (Drug): Weekly oral placebo pill mimicking alendronate. Administered to treatment group.

+Outcome measures

Primary outcomes

Change in Hounsfield Units (HU) at L1 Vertebra [Baseline, 3 months post-op, and 9 months post-op]: This measure assesses changes in vertebral bone quality by measuring Hounsfield Units (HU) at the L1 vertebra via CT scans. HU values will be compared from baseline to post-treatment between the romosozumab and alendronate groups to evaluate bone density improvement.
Change in Vertebral Bone Mineral Density (BMD) at L1 [Baseline, 3 months post-op, and 9 months post-op]: This measure evaluates the efficacy of romosozumab in improving vertebral bone density in older adults undergoing spine surgery. BMD will be measured using DXA scans of the total hip and compared from baseline to post-treatment between the romosozumab and alendronate groups.

Secondary outcomes

Change in L3 skeletal muscle index (L3 SMI) [Baseline, 3 months post-op, and 9 months post-op]: This measure assesses the impact of romosozumab on muscle mass in patients undergoing spine surgery. L3SMI will be calculated from axial CT scans at the L3 vertebral level, normalized by patient height squared. Changes from baseline will be compared between treatment and control groups.
Change in Oswestry Disability Index (ODI) [Baseline and 9 months post-op]: This measure evaluates change in patient-reported disability related to lower back pain using the ODI. Scores range from 0 to 100, with higher scores indicating greater disability.
Change in Visual Analog Scale (VAS) for Pain [Baseline and 9 months post-op]: This measure evaluates change in pain intensity using the VAS, which ranges from 0 (no pain) to 10 (worst possible pain).

+Eligibility

Sex: Female, ages: 65 Years to any

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

+Locations (1)

Facility	City	Country	Status
University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital	Pittsburgh, Pennsylvania	United States

+Investigators

Nitin Agarwal, M.D., Principal investigator, University of Pittsburgh