Bone Loss in Melanoma Survivors Receiving Immunotherapy

August 13, 2025 updated by: M.D. Anderson Cancer Center

Bone Loss in Cancer Survivors Receiving Adjuvant Immune Checkpoint Inhibitor Therapy

This study investigates the bone-related side effects caused by immunotherapy drugs such as nivolumab and pembrolizumab in patients with melanoma. Nivolumab and pembrolizumab are immunotherapy drugs (drugs that boost your immune system) used to prevent cancer from coming back in patients with melanoma. Specifically, researchers want to learn if there is any relationship between receiving immunotherapy and bone density (thickness) measured by a dual-energy X-ray absorptiometry (DXA) scan or bone turnover markers (which indicate levels of bone loss) found in the blood. This study may provide researchers with more information on bone loss and may help prevent bone loss in future patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Characterize the effects of adjuvant immune checkpoint inhibitor (ICI) therapy (nivolumab or pembrolizumab) on measures of bone health, including bone density and bone turnover markers, in a prospectively recruited cohort of 40 adult patients (>= 40 years) with melanoma diagnoses seen at MD Anderson Cancer Center.

II. Identify associations of baseline demographic, clinical, and general bone loss risk factors (e.g., age, corticosteroid use) and tumor characteristics with bone loss in the same cohort.

OUTLINE:

Patients undergo collection of blood samples after starting immunotherapy and then at 6 and 12 months. Patients also undergo DXA scan over 5-10 minutes after starting immunotherapy and at 12 months.

Study Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with stage III/IV melanoma receiving immune checkpoint inhibitor therapy at MD Anderson Cancer Center.

Description

Inclusion Criteria:

  • Stage III or IV melanoma with no evidence of disease following resection according to the 2009 American Joint Committee on Cancer classification criteria
  • No prior history of osteoporosis or fractures as per medical record review and patient history
  • Scheduled to begin receiving adjuvant ICI therapy (nivolumab or pembrolizumab) irrespective of dose or setting
  • Plan to continue care, including ICI infusions, at MD Anderson

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (biospecimen collection, DXA scan)
Patients undergo collection of blood samples after starting immunotherapy and then at 6 and 12 months. Patients also undergo DXA scan over 5-10 minutes after starting immunotherapy and at 12 months.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Procedure: Dual X-ray Absorptiometry
Undergo DXA scan
Other Names:
  • DEXA
  • DXA
  • BMD scan
  • bone mineral density scan
  • DEXA Scan
  • dual energy x-ray absorptiometric scan
  • Dual Energy X-ray Absorptiometry
  • Dual X-Ray Absorptometry
  • DXA SCAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in bone density
Time Frame: Baseline up to 6 months after treatment initiation
Evaluated using dual X-ray absorptiometry (DXA).
Baseline up to 6 months after treatment initiation
Change in done turnover markers
Time Frame: Baseline up to 6 months after treatment initiation
Evaluated in bone turnover markers (serum CTX and BSAP) in the study patients.
Baseline up to 6 months after treatment initiation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of fractures
Time Frame: Baseline to 1.5 years of follow-up
Will be assessed by review of patient's electronic medical records. Will evaluate the associations of each demographic, clinical, and general bone loss risk factor and tumor characteristic with change in bone density using linear regression models in univariate and multivariate settings. We will also summarize bone fractures descriptively according to the proportion of patients experiencing fractures and the time from treatment initiation to fracture.
Baseline to 1.5 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Noha Abdelwahab Hassan, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

June 18, 2025

Study Completion (Actual)

June 18, 2025

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-0353 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2020-05358 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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