Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis
In plain words An observational study of alpha-lactalbumin in female participants 35 to 70, run by Regina Elena Cancer Institute. It plans to enroll about 134 people at 2 sites, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists female participants 35 to 70. Conditions: Osteoporosis Secondary; Breast Cancer Females.
- caucasian women aged between 35 and 70;
- diagnosed with breast cancer undergoing treatment with aromatase inhibitors or tamoxifen + GnRH analogues or aromatase inhibitors + GnRH analogues not started more than 12 months ago, about to start treatment with oral bone resorption…
- vitamin D levels below 30 ng/ml (test carried out no more than 6 months prior to the baseline/T0 visit)
- patients able to comply with the procedures and/or requirements of the study
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Group 1: calcium carbonate/cholecalciferol; Group 2: Synostea® (calcium carbonate/cholecalciferol/vitamin K/α-lactalbumin/ d-chiro-inositol)
Registered summary
In women with breast cancer undergoing adjuvant hormone therapy, the marked tissue hypoestrogenism induced by therapy with aromatase inhibitors and/or tamoxifen ± GnRH analogues causes a significant acceleration in bone mass loss, with a consequent increased risk of fracture from the first year of therapy. It is therefore essential to start treatment with antiresorptive drugs and calcium and vitamin D supplementation. It has been hypothesized that vitamin K and α-lactalbumin have an effect in improving the absorption of calcium and vitamin D. The full summary is on the listing.
Where, as registered
No US site; Italy (2).