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Purpose

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, we 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. We 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. We 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 not guidelines in place notifying physicians of this potential risk to patients. Our 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥ 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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
  • Device: 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
  • Device: 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

Recruiting Locations

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Jennifer Whisenant, PhD
615-936-8422
j.whisenant@vumc.org

More Details

Status
Recruiting
Sponsor
Jessica Mezzanotte Sharpe

Study Contact

Jessica Sharpe, MD, PhD
615-936-8422
jessica.m.sharpe@vumc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.