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

NCT06973109 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: STUDY24090048BECKW 128792024YIRGA
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in Hounsfield Units (HU) at L1 Vertebra

  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.

  Baseline, 3 months post-op, and 9 months post-op

• Change in Vertebral Bone Mineral Density (BMD) at L1

  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.

  Baseline, 3 months post-op, and 9 months post-op

Secondary Outcomes (3)

• Change in L3 skeletal muscle index (L3 SMI)

  Baseline, 3 months post-op, and 9 months post-op

• Change in Oswestry Disability Index (ODI)

  Baseline and 9 months post-op

• Change in Visual Analog Scale (VAS) for Pain

  Baseline and 9 months post-op

Study Arms (2)

Romosozumab + Placebo Alendronate

EXPERIMENTAL

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.

Drug: Romosozumab; Drug: Placebo Alendronate

Alendronate + Placebo Romosozumab

ACTIVE COMPARATOR

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.

Drug: Alendronate (Fosamax); Drug: Placebo Romosozumab

Interventions

Romosozumab 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.

Also known as: Evenity

Romosozumab + Placebo Alendronate

Alendronate (Fosamax) DRUG

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

Also known as: Fosamax

Alendronate + Placebo Romosozumab

Placebo Romosozumab DRUG

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

Alendronate + Placebo Romosozumab

Placebo Alendronate DRUG

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

Romosozumab + Placebo Alendronate

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nitin Agarwal: lead
• Amgen: collaborator
• Beckwith Foundation: collaborator

Study Sites (1)

University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

romosozumab; Alendronate

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Nitin Agarwal, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rohit Prem Kumar, M.D.

CONTACT

609-613-3465; kumarrp@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 15, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): March 2, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available beginning 12 months after publication of the primary results and will remain available for 5 years thereafter.
• Access Criteria: Qualified researchers with a methodologically sound proposal may request access to the data by contacting the study principal investigator. Requestors will need to complete a data use agreement. Data will be provided via a secure online platform after IRB approval and review of the request by the study team.

Locations

US (1)