Postmenopausal women with vitamin D deficiency. MedDRA version: 20.0 Level: PT Classification code 10047626 Term: Vitamin D deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Hidroferol 0,266 mg c¿psulas blandas
Product Name: Hidroferol® Soft Gelatine Capsules
Product Code: [HIDR-0217/OST]
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CALCIFEDIOLO
CAS
Sponsors
FAES FARMA, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 176
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the percentage of patients achieving 25(OH)D levels above 30 ng/mL at 4 months of treatment in each of the treatment groups investigated.;Secondary Objective: -To assess the percentage of patients achieving 25(OH)D levels above 30 ng/mL at 1, 8, and 12 months of treatment in each of the treatment groups investigated. -Time to achieve the treatment goal (> 30 ng/mL) in each of the treatment investigated. -Mean change in 25(OH)D levels at 1, 4, 8, and 12 months in each of the treatments investigated. -Change in levels of bone resorption markers CTX and P1NP in the stratum of non-osteoporotic patients at baseline, 4, 8, and 12 months in each of the treatments investigated. -Change in levels of total serum calcium (tCa), PTH, albumin, phosphorus and total alkaline phosphatase at screening, 1, 4, 8 and 12 months in each of the treatments investigated. -Modulation of 25(OH)D levels according to phenotype taking into account the age and obesity (BMI and abdominal circumference). ....;Primary end point(s): Percentage of patients achieving 25(OH)D levels above 30 ng/mL at 4 months of treatment.;Timepoint(s) of evaluation of this end point: 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients achieving 25(OH)D levels above 30 ng/mL at 1, 8, and 12 months of treatment.; Mean change from screening of 25(OH)D serum concentrations at 1, 4, 8, and 12 months of treatment.; Time to achieve treatment objective. (25(OH)D > 30 ng/mL) ; Serum concentrations of total serum calcium (tCa), PTH, albumin, phosphorus and total alkaline phosphatase will be assessed at screening and at 1, 4, 8, and 12 months.; Serum concentrations of P1NP and ¿-CTX at baseline, 4, 8, and 12 months in non-osteoporotic patients.;Timepoint(s) of evaluation of this end point: 1, 8, 12 months; 1, 4, 8, and 12 months; \; 1, 4, 8, and 12 months; at baseline, 4, 8, and 12 months | — |
Countries
Italy, Portugal, Spain
Contacts
Public ContactServizio Informazione sulla Sperime
Pharmaceutical Development and Services srl
Outcome results
None listed