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

RecruitingNAAges 18 Years - anyAllJessica Mezzanotte Sharpe
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In plain words

What the trial is, and whether it could suit you

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 fracture

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 18 years. 2. 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). 3. Life expectancy of at least 12 months per the discretion of the treating physician. Exclusion Criteria: 1. Patients ineligible for anti-PD-1 therapy. 2. Patients with metastatic disease. 3. Patients planning treatment with dual immune checkpoint inhibitor therapy. 4. Bony fractures in the pelvis, bilateral hips/femurs, thoracic spine, or lumbar spine. 5. Known osteoporosis or osteopenia. 6. Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months. 7. Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV/V, or ESRD. 8. Inability to comply with study procedures. 9. Inability to lie flat for 20-25 minutes during an imaging session. 10. Pregnant or breastfeeding patients. 11. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.
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What it tests

  • Dual-Energy X-ray Absorptiometry (DXA)
  • High Resolution peripheral Quantitative Computed Tomography (HRpQCT)
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Where

1 site
Vanderbilt-Ingram Cancer Center
Nashville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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