Clinical trial NCT06973109: Romosozumab Effects on Bone Density, Muscle Mass, and Spine Surgery Outcomes
Official title: Investigating the Efficacy of Romosozumab in Augmenting Bone Density and Muscle Mass to Enhance the Outcomes of Spine Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Osteoporosis, Post-menopausal
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Amgen
name: Beckwith Foundation
First posted: 2025-05-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in Hounsfield Units (HU) at L1 Vertebra
timeFrame: Baseline, 3 months post-op, and 9 months post-op
measure: Change in Vertebral Bone Mineral Density (BMD) at L1
timeFrame: Baseline, 3 months post-op, and 9 months post-op
Secondary outcomes:
measure: Change in L3 skeletal muscle index (L3 SMI)
timeFrame: Baseline, 3 months post-op, and 9 months post-op
measure: Change in Oswestry Disability Index (ODI)
timeFrame: Baseline and 9 months post-op
measure: Change in Visual Analog Scale (VAS) for Pain
timeFrame: Baseline and 9 months post-op
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Nitin Agarwal, M.D.
role: PRINCIPAL_INVESTIGATOR
References: