Osteoporosis, Post-menopausal
Conditions
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
Interventions
DRUGRomosozumab
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.
Weekly oral dose (70 mg) administered for 12 months. Used as active comparator in control arm of study.
DRUGPlacebo Romosozumab
Monthly subcutaneous injections mimicking romosozumab in appearance and administration schedule. Administered to control group.
Weekly oral placebo pill mimicking alendronate. Administered to treatment group.
Sponsors
University of Pittsburgh
Amgen
Beckwith Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hounsfield Units (HU) at L1 Vertebra | Baseline, 3 months post-op, and 9 months post-op | 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. |
| Change in Vertebral Bone Mineral Density (BMD) at L1 | Baseline, 3 months post-op, and 9 months post-op | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in L3 skeletal muscle index (L3 SMI) | Baseline, 3 months post-op, and 9 months post-op | This measure assesses the impact of romosozumab on muscle mass in patients undergoing spine surgery. L3SMI will be calculated from axial CT scans at the L3 vertebral level, normalized by patient height squared. Changes from baseline will be compared between treatment and control groups. |
| Change in Oswestry Disability Index (ODI) | Baseline and 9 months post-op | This measure evaluates change in patient-reported disability related to lower back pain using the ODI. Scores range from 0 to 100, with higher scores indicating greater disability. |
| Change in Visual Analog Scale (VAS) for Pain | Baseline and 9 months post-op | This measure evaluates change in pain intensity using the VAS, which ranges from 0 (no pain) to 10 (worst possible pain). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNitin Agarwal, M.D.
University of Pittsburgh
Outcome results
None listed