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

Nitin Agarwal

Status and phase: Not yet enrolling; Phase 2

Conditions: Osteoporosis, Post-menopausal

Treatments: Drug: Romosozumab; Drug: Placebo Romosozumab; Drug: Alendronate (Fosamax); Drug: Placebo Alendronate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06973109

BECKW 12879 (Other Grant/Funding Number)

STUDY24090048

2024YIRGA (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Romosozumab + Placebo Alendronate

Experimental group

Description:

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.

Treatment:

Drug: Placebo Alendronate

Drug: Romosozumab

Alendronate + Placebo Romosozumab

Active Comparator group

Description:

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.

Treatment:

Drug: Alendronate (Fosamax)

Drug: Placebo Romosozumab