EUCTR2013-002648-10-IT进行中（未招募）不适用
THE EFFECT OF A DAILY AND WEEKLY ADMINISTRATION OF DIFFERENT DOSES OF CALCIDIOL ON 25(OH)D3 SERUM LEVELS AND ON MINERAL AND BONE METABOLIC MARKERS IN POSTMENOPAUSAL FEMALE SUBJECTS OVER 55 YEARS OF AGE WITH INADEQUATE LEVELS OR DEFICIT OF 25(OH)D3 - ADDI-D
Bruno Farmaceutici S.p.a.0 个研究点开始时间: 2014年2月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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