Bone Loss in Melanoma Survivors Receiving Immunotherapy

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.

• Biospecimen Collection (Procedure): Undergo collection of blood samples
• Dual X-ray Absorptiometry (Procedure), also known as BMD scan, bone mineral density scan, DEXA, DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN: Undergo DXA scan

Primary outcomes

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

Secondary outcomes

• Development of fractures [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.

Sex: All, ages: 40 Years to any

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

• Informed Consent Form (PDF, 2021-05-10)

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