Effect of the administration of different Hidroferol¿ Soft Gelatine Capsules (calcifediol) and cholecalciferol (Dibase¿) regimens on vitamin D levels and markers of bone remodelling in postmenopausal women with vitamin D deficiency. Influence of clinical and genetic factors in the population with or without osteoporosis.

Phase 1

• Conditions: Postmenopausal women with vitamin D deficiency.; MedDRA version: 20.0Level: PTClassification code 10047626Term: Vitamin D deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-004028-31-IT
• Lead Sponsor: FAES FARMA, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-27
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

-Postmenopausal women: amenorrhea for more than 6 months or FSH above 30 IU/l with estradiol under 30 pg/mL.
-Women with vitamin D deficiency (25-hydroxycholecalciferol levels < 20
ng/mL).
-Postmenopausal patients who are NON-OSTEOPOROTIC and are NOT receiving treatment with drugs affecting bone metabolism OR postmenopausal patients who are OSTEOPOROTIC and receiving treatment WITH antiresorptives, biphosphonates or denosumab.
-Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 124
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 176

Exclusion Criteria

-Patients taking drugs that modify vitamin D levels: phenobarbital, phenytoin, rifampicin, antiretrovirals (tenofivir, adenofivir), long-term corticosteroids, orlistat and cholestiramine.
-Patients taking any nutritional supplement such as vitamin complexes.
-Patients diagnosed with malabsorption
-Patients with kidney stones
-Patients with primary hyperparathyroidism
-Patients with hyperthyroidism
-Patients with hypercalcemia
-Patients with creatinine clearance < 30 mL/min
-Patients with tumours within the last 5 years
-Patients who have a history with evidence of diseases, medications, laboratory abnormalities or any other circumstance that could alter the conduct of the study
-Patients who are allergic to any of the ingredients of the medication etanol, medium-chain triglycerides, gelatine, vegetal glicerine, sorbitol (E-420), titanium dioxide (E-171),orangish yellow colorant and purified water. refined olive oil)
-Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the screening or is currently enrolled in an investigational interventional study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified