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

NCT ID: NCT06973109

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-26
• Study Completion Date: 2027-06-30

Brief 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

Conditions

Osteoporosis, Post-menopausal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Romosozumab + 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.

Group Type: EXPERIMENTAL

Romosozumab

Intervention Type: DRUG

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.

Placebo Alendronate

Intervention Type: DRUG

Weekly oral placebo pill mimicking alendronate. Administered to treatment group.

Alendronate + 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.

Group Type: ACTIVE_COMPARATOR

Alendronate (Fosamax)

Intervention Type: DRUG

Weekly oral dose (70 mg) administered for 12 months. Used as active comparator in control arm of study.

Placebo Romosozumab

Intervention Type: DRUG

Monthly subcutaneous injections mimicking romosozumab in appearance and administration schedule. Administered to control group.

Interventions

Romosozumab

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.

Intervention Type: DRUG

Alendronate (Fosamax)

Weekly oral dose (70 mg) administered for 12 months. Used as active comparator in control arm of study.

Intervention Type: DRUG

Placebo Romosozumab

Monthly subcutaneous injections mimicking romosozumab in appearance and administration schedule. Administered to control group.

Intervention Type: DRUG

Placebo Alendronate

Weekly oral placebo pill mimicking alendronate. Administered to treatment group.

Intervention Type: DRUG

Other Intervention Names

Evenity; Fosamax

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: collaborator

Beckwith Foundation

UNKNOWN

Sponsor Role: collaborator

Nitin Agarwal

OTHER

Sponsor Role: lead

Responsible Party

Nitin Agarwal

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nitin Agarwal, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Central Contacts

Rohit Prem Kumar, M.D.

Role: CONTACT

kumarrp@upmc.edu

609-613-3465

Facility Contacts

Rohit Kumar, M.D.

Role: primary

kumarrp@upmc.edu

609-613-3465

Other Identifiers

BECKW 12879

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024YIRGA

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY24090048

Identifier Type: -

Identifier Source: org_study_id