Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in BMD using DXA
研究概览
简要总结
Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases. Some patients may suffer acute and treatable complications like joint pain, but some may have irreversible complications like hypothyroidism that requires daily, life-long medication. It is therefore important to fully understand the different types of damage ICIs can cause to better monitor patients receiving ICI therapy.
A rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton.
The investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in combination with chemotherapy for curative intent for a known cancer diagnosis (use of immunotherapy must be FDA-approved and not experimental).
- •Life expectancy of at least 12 months per the discretion of the treating physician.
排除标准
- •Patients ineligible for anti-PD-1 therapy.
- •Patients with metastatic disease.
- •Patients planning treatment with dual immune checkpoint inhibitor therapy.
- •Bony fractures in the pelvis, bilateral hips/femurs, thoracic spine, or lumbar spine.
- •Known osteoporosis or osteopenia.
- •Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.
- •Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV/V, or ESRD.
- •Inability to comply with study procedures.
- •Inability to lie flat for 20-25 minutes during an imaging session.
- •Pregnant or breastfeeding patients.
- •Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.
研究组 & 干预措施
Bone mineral density scans (DXA and HRpQCT)
Patients undergo two research bone mineral density scans (DXA and HRpQCT) at three time points: baseline, 4-6 months during immunotherapy, and after 12 months of immunotherapy
干预措施: Dual-Energy X-ray Absorptiometry (DXA) (Device)
Bone mineral density scans (DXA and HRpQCT)
Patients undergo two research bone mineral density scans (DXA and HRpQCT) at three time points: baseline, 4-6 months during immunotherapy, and after 12 months of immunotherapy
干预措施: High Resolution peripheral Quantitative Computed Tomography (HRpQCT) (Device)
结局指标
主要结局
Change in BMD using DXA
时间窗: At 12 months after starting immunotherapy
Assess changes in BMD on DXA scans in patients undergoing anti-PD-1 therapy over the course of a year.
次要结局
- Change in plasma markers of bone resorption and formation(At 12 months after starting immunotherapy)
- Fracture incidence(To be completed within 30 days of the end of study (12 months +/-30 days))
- Rates of documented immune-related adverse events (irAE)(To be completed within 30 days of the end of study (12 months +/-30 days))
研究者
Jessica Mezzanotte Sharpe
Assistant Professor
Vanderbilt-Ingram Cancer Center