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

NCT06973109 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-09

No results posted yet for this study

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

Interventions

DRUG

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.

DRUG

Alendronate (Fosamax)

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

DRUG

Placebo Romosozumab

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

DRUG

Placebo Alendronate

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

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Beckwith Foundation

    collaborator UNKNOWN

  • Nitin Agarwal

    lead OTHER

Principal Investigators

  • Nitin Agarwal, M.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-20
Primary Completion
2027-03-02
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06973109 on ClinicalTrials.gov