Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy

Официальное название

Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents

Обзор

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.

Вмешательства

• Устройство Dual-Energy X-ray Absorptiometry (DXA)
  Research participants undergo both DXA scans at baseline (within 1 month of starting immunotherapy), 4-6 months after starting immunotherapy, and after 12 months of immunotherapy
• Устройство High Resolution peripheral Quantitative Computed Tomography (HRpQCT)
  Research participants undergo both HRpQCT scans at baseline (within 1 month of starting immunotherapy), 4-6 months after starting immunotherapy, and after 12 months of immunotherapy

Первичные конечные точки

• Change in BMD using DXA [Срок оценки: At 12 months after starting immunotherapy]

Вторичные конечные точки (3)

• Change in plasma markers of bone resorption and formation [Срок оценки: At 12 months after starting immunotherapy]
• Fracture incidence [Срок оценки: To be completed within 30 days of the end of study (12 months +/-30 days)]
• Rates of documented immune-related adverse events (irAE) [Срок оценки: To be completed within 30 days of the end of study (12 months +/-30 days)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Vanderbilt-Ingram Cancer Center — Nashville

Идентификаторы

NCT: NCT07555210 · VICCMD25019 · #242079

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗