THE EFFECT OF A DAILY AND WEEKLY ADMINISTRATION OF CALCIDIOL IN POSTMENOPAUSAL FEMALE SUBJECTS OVER 55 YEARS OF AGE
- Conditions
- Postmenopausal female subjects with inadequate levels or deficit of 25(OH)D3Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-002648-10-IT
- Lead Sponsor
- Bruno Farmaceutici S.p.a.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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 <30 kg/sq.m
6.Capable of understanding the purpose and risks of the study, fully informed and having given written informed consent (signed Informed Consent has been obtained).
7.Life expectancy sufficient to participate in the entire course of study
8.Vitamin D status as follows:
a.All subjects should have 25(OH)D3 serum concentrations <30 ng/ml
9.Intake of 1000 mg/day of calcium
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
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 <30 ml/min for males and 0.85 times this value for females)
8.Paget’s disease of bone
9.Hyper- or hypo-parathyroidism
10.Hypercalcemia
11.Sarcoidosis
12.Documented hypercalciuria without any calcium supplementation (>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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method