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Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes | Clinical Trials | Clareo Health

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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

NCT06973109•Nitin Agarwal

View on ClinicalTrials.gov

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

Eligibility

Age

65 - No limit years

Sex

FEMALE

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).
+4 more criteria

Locations (1)

University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

March 20, 2026

Primary Completion Date

March 2, 2027

Completion Date

June 1, 2027

Last Updated

March 9, 2026

Enrollment

ESTIMATED participants

Conditions

Osteoporosis, Post-menopausal

Interventions

Romosozumab

DRUG

Alendronate (Fosamax)

DRUG

Placebo Romosozumab

DRUG

Placebo Alendronate

DRUG

Contacts

Rohit Prem Kumar, M.D.

CONTACT

609-613-3465 kumarrp@upmc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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