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Cancer immunotherapy may weaken bones, new study warns

NCT ID NCT07555210

Knowledge-focused Sponsor: Jessica Mezzanotte Sharpe Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how immunotherapy drugs (anti-PD-1) affect bone strength in people being treated for cancer. Researchers will measure bone density and blood markers over a year in 25 patients. The goal is to understand if these treatments increase fracture risk, so doctors can better monitor and protect bone health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm classic Hodgkin lymphoma invasive breast carcinoma kidney cancer melanoma non-small cell lung carcinoma oral cavity squamous cell carcinoma rectal cancer renal cell carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer (triple negative breast cancer (TNBC)) Classic Hodgkin lymphoma Invasive mammary carcinoma Melanoma (skin cancer) Msi-H/DMMR rectal cancer Non small cell lung cancer Renal cell carcinoma (kidney cancer) Squamous cell carcinoma mouth

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vanderbilt-Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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