Effect of Vitamin K, D-chiro Inositol, and alpha-lactalbumin on Bone Health in Women with Breast Cancer Receiving Aromatase Inhibitors

What this Trial Is About

This research aims to evaluate the effects of a combination of vitamin K, -lactalbumin, and D-chiro-inositol on bone health in women with breast cancer undergoing hormone therapy that induces significant bone loss. The study focuses on how these nutrients may improve calcium and vitamin D absorption and enhance bone remodeling, potentially supporting the antiresorptive effects of standard bisphosphonate treatment in preventing osteoporosis caused by cancer therapy. Participants will receive either standard therapy with calcium carbonate and cholecalciferol or a combination supplement called Synostea, which includes calcium carbonate, cholecalciferol, vitamin K, -lactalbumin, and D-chiro-inositol. This randomized pilot trial compares these two groups to assess differences in calcium-phosphorus metabolism and bone mineral density over six to twelve months. During the study, researchers will measure vitamin D levels after six months and evaluate various bone health markers such as bone mineral density in the hip and lumbar regions, serum calcium, parathyroid hormone, bone alkaline phosphatase, and urinary calcium excretion at six and twelve months. Treatment adherence and bone fragility scores will also be monitored, with the total study duration extending up to twelve months for most assessments.

Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis