Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Breast Neoplasms

Osteoporosis

Breast Diseases

Skin Diseases

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

Vitamins

Vitamin D

Cholecalciferol

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

High dose vitamin D: Subjects will receive 50,000 IU vitamin D2 weekly x 16 weeks followed by 4,000 IU of vitamin D3 daily with a goal 25(OH)D level of ≥45 but ≤80 ng/mL.

High Dose Vitamin D

Standard of Care Vitamin D: Vitamin D will be supplemented to 25(OH)D levels, with a goal 25(OH)D level of \>30 ng/mL according to Endocrine Society Practice Guidelines.

Standard of Care Vitamin D

Arielle Heeke, MD

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.

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.

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

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

Descriptively summarize vitamin D administration for the high dose vitamin D arm and for the current standard vitamin D treatment administration algorithm in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on adverse events of special interest (vitamin D related headaches, irritability, spasticity, nausea, vomiting, and hypercalcemia) in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on adverse events of special interest (vitamin D related headaches, irritability, spasticity, nausea, vomiting, and hypercalcemia) that results in vitamin D dose modifications or discontinuations in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on serious adverse events in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on treatment discontinuation due to vitamin D intake non-compliance.

Compare 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) to the Year 1 planned DEXA scan, in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm 25(OH) D levels in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on PRAI questionnaire results in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on overall satisfaction with pain control in young women with non-metastatic breast cancer who receive systemic therapy.

Compare effect of high dose vitamin D to the current standard vitamin D treatment administration algorithm on skeletal complications in young women with non-metastatic breast cancer who receive systemic therapy.

Spots Global Cancer Trial Database for standard of care vitamin d