Investigating the Efficacy of Romosozumab in Augmenting Bone Density and Muscle Mass to Enhance the Outcomes of Spine Surgery
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Hounsfield Units (HU) at L1 Vertebra
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Placebo Alendronate (Drug)
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.
干预措施: Placebo Romosozumab (Drug)
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.
干预措施: Alendronate (Fosamax) (Drug)
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.
干预措施: Romosozumab (Drug)
结局指标
主要结局
Change in Hounsfield Units (HU) at L1 Vertebra
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Nitin Agarwal
Associate Professor
University of Pittsburgh