Actively Recruiting
Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents
Led by Jessica Mezzanotte Sharpe · Updated on 2026-05-06
25
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Immune checkpoint inhibitors (ICIs) are a type of cancer treatment that help the immune system recognize and attack cancer cells. They are approved for many cancers and stages but can cause inflammation and damage in organs, sometimes leading to serious complications. This research focuses on how ICIs might weaken bones and increase fracture risk, which is a growing concern as more patients receive these therapies. The study aims to better understand bone changes in patients receiving ICIs to help improve monitoring and care in the future. Participants will undergo bone density scans using two devices: Dual-Energy X-ray Absorptiometry (DXA) and High Resolution peripheral Quantitative Computed Tomography (HRpQCT). These scans will be done three times: before or within one month of starting ICI treatment, at 4 to 6 months during treatment, and after 12 months of immunotherapy. The study includes patients treated with anti-PD-1 immunotherapy alone or combined with chemotherapy for curative intent. During the study, researchers will track changes in bone mineral density, bone structure, and blood markers related to bone health at these three time points. They will also monitor fractures and immune-related side effects during the 12-month treatment period. This will help measure how ICI therapy affects bone strength and risks. The total participation time is about one year, with scans and blood tests to evaluate bone health and safety throughout the treatment.
CONDITIONS
Brief Title
Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Planning to start or within the first four weeks of anti-PD-1 immunotherapy for curative treatment of a known cancer
- Life expectancy of at least 12 months as judged by the treating physician
You will not qualify if you...
- Ineligible for anti-PD-1 therapy
- Having metastatic disease
- Planning treatment with dual immune checkpoint inhibitors
- History of fractures in pelvis, hips, or spine
- Known osteoporosis or osteopenia
- Recent or planned treatment with denosumab, zoledronic acid, or other bisphosphonates within 6 months
- Parathyroid disorders, rheumatoid arthritis (unless well-controlled without biologic therapy or steroids), advanced kidney disease (CKD stage IV/V or ESRD)
- Unable to follow study procedures
- Unable to lie flat for 20-25 minutes during imaging
- Pregnant or breastfeeding
- Medical or psychiatric conditions preventing successful study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 12 months
Participants undergo bone mineral density scans using DXA and HRpQCT at baseline, 4-6 months, and 12 months during immunotherapy treatment.
3 visits for scans (baseline, 4-6 months, and 12 months)
Trial Site Locations
Total: 1 location
1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
J
Jessica Sharpe, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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