Postmenopausal female subjects with inadequate levels or deficit of 25(OH)D3
Conditions
Interventions
Trade Name: DIDROGYL
Pharmaceutical Form: Oral drops
Sponsors
Bruno Farmaceutici S.p.a.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Demographic characteristics 1. Caucasian 2. Aged >55 years 3. Postmenopausal status for female subjects (>2 years after last menstruation) Medical and therapeutic criteria 4. Ambulatory (ability to walk independently) 5. BMI =65 years) yes F.1.3.1 Number of subjects for this age range 54
Exclusion criteria
Exclusion criteria: General criteria 1. Unlikely to co-operate in the study and to comply with the visits scheduled in the protocol 2. Simultaneously participating or having participated in another clinical trial with an investigational drug within 3 months previous to the admission in this study 3. Subjects belonging to any of the following categories: incarcerated persons, subjects in an emergency situation, subject with severe mental disorders, patients legally incapacitated. Medical and therapeutic criteria 4. Progressive major illness (CVD, HIV, diabetes, active hepatitis B or C) 5. Planned hospitalization longer than 2 weeks during the course of the study (3- months) 6. Severe malabsorption syndrome 7. Severe renal insufficiency (Creatinine clearance 300 mg/24 hours), especially in case of history of renal lithiasis 13. History of intolerance, allergy or hypersensitivity to Didrogyl 14. Treatments interfering with bone and mineral metabolism: - Vitamin D treatment >400 IU/day in the previous month before selection or doses >10000 IU within the previous 3 months or doses >50000 IU within the previous 12 months - Calcitriol and alfacalcidol (above 0.25 µg/day) during the previous 6 months - Lithium, thiazides - Glucocorticoids: Oral long-term treatment: more than 5 mg/day equivalent prednisolone for more than 8 months during the previous year or more than 2 g equivalent prednisolone in the previous year Inhaled long-term treatment steroids: more than 1000 microgram/day for more than 6-months in the previous year. - Immunosuppressants (cyclosporine, azathioprine) within the previous year - Antiretroviral therapy - Treatments interfering with vitamin D absorption or catabolism: Olestra, mineral oils, orlistat, bile acid sequestrants (cholestyramine, Colestipol), cimetidine, Ketoconazol, in the previous 2 weeks., Vitamin A (excluding beta-carotene) in excess of 10000 IU/day in the previous last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effects on the increase of circulating levels of 25(OH)D3 of three different therapeutic regimens of Calcidiol (Didrogyl);Secondary Objective: To compare the effects of three different therapeutic regimens of Calcidiol (Didrogyl) on changes of serum and the urinary levels of mineral and bone biomarkers compared to baseline.;Primary end point(s): Efficacy: Circulating values of 25(OH)D3 at 3 months of treatment;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Serum calcium, phosphorus, creatinine, protein/albumin, ionized calcium, bone Alkaline Phosphatase (BAP), C-terminal telopeptides of type I collagen (CTX), Parathyroid Hormone (PTH), 1,25(OH)2D3, Fibroblast Growth Factor 23 (FGF 23), and vitamin D Binding Protein (D-BP) over 3 months of treatment Urinary (24 hr) calcium, phosphorus, creatinine, and deoxypyridinoline (DPD) over 3 months of treatment Safety: - Incidence of AEs - Laboratory parameters - Laboratory parameters of particular interest : calcemia, protein/albumin, ionized calcium,. CTX and 25(OH)D3 and 24 hr urinary calcium, creatinine, and D-PD ;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
Italy
Contacts
Public ContactReception
Bruno Farmaceutici S.p.a.
Outcome results
None listed