Spots Global Cancer Trial Database for A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation

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Trial Identification

Brief Title: A Study of High-Dose Vit D Versus Standard of Care Vit D Supplementation

Official Title: A Randomized, Open-label Study of High-Dose Vitamin D Versus Standard of Care Vitamin D Supplementation to Evaluate the Impact on Bone Health in Young Women With Early Stage Breast Cancer

Study ID: NCT05016310

Conditions

Breast

Breast Cancer

Osteoporosis

Interventions

High Dose Vitamin D

Standard of Care Vitamin D

Study Description

Brief Summary: This is a randomized study evaluating the effects of early intensive vitamin D supplementation compared to standard of care vitamin D supplementation on bone health over an 18 month period.

Detailed Description: This is a randomized, open-label study designed to evaluate the effect of high dose vitamin D versus standard of care vitamin D supplementation on bone health and arthralgias. The randomization will be stratified by hormone receptor status (positive versus negative). The primary objective is to compare the effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on bone health, as measured by percent change from baseline in bone mineral density (g/cm2), in young women with non-metastatic breast cancer who receive systemic therapy.