Actively Recruiting

Age: 35Years - 70Years
FEMALE
ID07256769

Synergic Role of Vitamin K, D-chiro Inositol, and α-lactalbumin in Bone Homeostasis in Breast Cancer Patients Treated With Aromatase Inhibitors

Led by Regina Elena Cancer Institute · Updated on 2025-12-01

134

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of a combination of vitamin K, α-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, α-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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 35Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Caucasian women aged between 35 and 70
  • Diagnosed with breast cancer and treated with aromatase inhibitors or tamoxifen plus GnRH analogues or aromatase inhibitors plus GnRH analogues started within the last 12 months
  • About to start treatment with oral bone resorption inhibitors (alendronate)
  • Vitamin D levels below 30 ng/ml tested within 6 months prior to baseline
  • Able to comply with study procedures and requirements
  • Provided informed consent for participation and data processing
Not Eligible

You will not qualify if you...

  • Uncontrolled diabetes mellitus (HbA1c 8%) or severe chronic renal failure (eGFR <30 ml/min)
  • Primary or secondary hyperparathyroidism due to chronic renal failure
  • Baseline vitamin D levels greater than 30 ng/ml
  • Already treated with antiresorptive drugs
  • Undergoing steroid therapy
  • Using other forms of vitamin D (calcifediol, calcitriol) or requiring high calcium doses (hypoparathyroidism)
  • Taking drugs that affect calcium excretion (diuretics)
  • Unable to comply with study procedures required by the protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants take either standard therapy with calcium carbonate and cholecalciferol or Synostea®, a combination supplement including calcium carbonate, cholecalciferol, vitamin K, α-lactalbumin, and d-chiro-inositol, to support bone health while undergoing treatment with oral bone resorption inhibitors.

Visits at baseline and 6 months for assessment of vitamin D levels and other parameters

Follow-up

Duration - 6 additional months after treatment

Participants are monitored for changes in bone mineral density, bone health markers, and treatment adherence to evaluate the long-term effects of the supplements.

Visits at 12 months for comprehensive bone health evaluation

Trial Site Locations

Total: 2 locations

1

Santa Maria Goretti Hospital

Latina, Italy, Italy, 04100

Not Yet Recruiting

2

Regina Elena National Cancer Institute

Roma, Italy, Italy, 00144

Actively Recruiting

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Research Team

M

Marialuisa Appetecchia, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Calcium bioaccessibility and uptake by human intestinal like cells following in vitro digestion of casein phosphopeptide-calcium aggregates.

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Response of serum carboxylated and undercarboxylated osteocalcin to alendronate monotherapy and combined therapy with vitamin K2 in postmenopausal women.

Makoto Hirao, Jun Hashimoto, Wataru Ando...

https://pubmed.ncbi.nlm.nih.gov/18470667

Effects of risedronate alone or combined with vitamin K2 on serum undercarboxylated osteocalcin and osteocalcin levels in postmenopausal osteoporosis.

Yuji Kasukawa, Naohisa Miyakoshi, Toshihito Ebina...

https://pubmed.ncbi.nlm.nih.gov/23846118

The Importance of Vitamin K and the Combination of Vitamins K and D for Calcium Metabolism and Bone Health: A Review.

Jan O Aaseth, Trine Elisabeth Finnes, Merete Askim...

https://pubmed.ncbi.nlm.nih.gov/39125301