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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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
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.

Jessica Sharpe, MD, PhD contact

615-936-8422

jessica.m.sharpe@vumc.org

United States1 site, 1 recruiting
  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

    Jennifer Whisenant, PhD, 615-936-8422, j.whisenant@vumc.org

    Jessica Sharpe, MD, PhD

    Recruiting

Other trials in United States

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.

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 groups in NCT07555210
Study groupRoleWhat they receive
Bone mineral density scans (DXA and HRpQCT)ExperimentalPatients 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.

  1. 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)
  1. 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

  2. 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)

  3. 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.

  1. First posted29 Apr 2026
  2. Study start25 Aug 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

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)
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

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