Breast Cancer (Triple Negative Breast Cancer (TNBC))NCT07555210
Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy
A study testing Dual-Energy X-ray Absorptiometry (DXA) and High Resolution peripheral Quantitative Computed Tomography (HRpQCT) in people with Breast Cancer (Triple Negative Breast Cancer (TNBC)) and Renal Cell Carcinoma (Kidney Cancer), run by Jessica Mezzanotte Sharpe at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer (Triple Negative Breast Cancer (TNBC)), Renal Cell Carcinoma (Kidney Cancer), Melanoma (Skin Cancer)
- What is being tested?
- Dual-Energy X-ray Absorptiometry (DXA) and High Resolution peripheral Quantitative Computed Tomography (HRpQCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2025to 1 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Jennifer Whisenant, PhD, 615-936-8422, j.whisenant@vumc.org
Jessica Sharpe, MD, PhD
About this study
Official title: Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents
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.
- Conditions
- Breast Cancer (Triple Negative Breast Cancer (TNBC)), Renal Cell Carcinoma (Kidney Cancer), Melanoma (Skin Cancer), Non-Small Cell Lung Cancer, MSI-H/dMMR Rectal Cancer, Squamous Cell Carcinoma Mouth
- Being tested
- Dual-Energy X-ray Absorptiometry (DXA), High Resolution peripheral Quantitative Computed Tomography (HRpQCT)
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Renal Cell, Kidney Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-Energy X-ray Absorptiometry (DXA)Device
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
High Resolution peripheral Quantitative Computed Tomography (HRpQCT)Device
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
| Study group | Role | What they receive |
|---|---|---|
| Bone mineral density scans (DXA and HRpQCT) | Experimental | 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 Receives: Device: Dual-Energy X-ray Absorptiometry (DXA); Device: High Resolution peripheral Quantitative Computed Tomography (HRpQCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMD using DXA
Assess changes in BMD on DXA scans in patients undergoing anti-PD-1 therapy over the course of a year.
Measured: At 12 months after starting immunotherapy
Secondary outcomes (3)
Change in plasma markers of bone resorption and formation
Examine plasma markers of bone resorption and formation over the course of a year in patients undergoing neoadjuvant treatment.
Measured: At 12 months after starting immunotherapy
Fracture incidence
Monitor fracture incidence in patients being treated with anti-PD-1 therapy and explore whether these are correlated with an increased risk of BMD loss.
Measured: To be completed within 30 days of the end of study (12 months +/-30 days)
Rates of documented immune-related adverse events (irAE)
Monitor rates of irAEs in patients being treated with anti-PD-1 therapy and explore whether these are correlated with an increased risk of BMD loss.
Measured: To be completed within 30 days of the end of study (12 months +/-30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start25 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Triple Negative Breast Cancer (TNBC))Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessica Mezzanotte Sharpe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jessica Mezzanotte Sharpe, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555210
- Sponsor's protocol ID
- VICCMD25019
- Other IDs
- #242079
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided