EUCTR2008-002280-14-FR进行中（未招募）1 期
Comparative study of the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on bone biomarkers in young women with low calcium intake. Prospective, monocenter, randomized, open-label, two-period,cross-over trial
Pierre Fabre Médicament0 个研究点目标入组 58 人开始时间: 2008年6月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
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
- •- volunteers females aged between 18 and 30 years included
- •- with a dietary calcium intake between 300 and 600 mg/day
- •- using combined oral contraceptives with a stable dosage for at least 3 months
- •- willing and able to understand and sign an approved Informed Consent Form
- •- able to understand the protocol and to come to the control visits
- •- registered with a social security or health insurance system.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- past or current history of a metabolic (including phenylketonuria) or hereditary bone disease, an intestinal malabsorption, liver disease, thyroid or parathyroid disease
- •- chronic renal failure or chronic kidney disease or history of renal calculi
- •- inflammatory bowel disease or any digestive disease which could modify calcium absorption
- •- any disease that could significantly alter the calcium and / or phosphorus metabolism or bone metabolism
- •- subject having had a fracture or a prolonged immobilization during the 12 months preceding the selection
- •- subject receiving or expected to receive during the course of the study any treatment by inhibitors of bone resorption, bisphosphonates, parathyroid, thyroxin, systemic corticosteroids, anticonvulsants, a treatment with calcium and / or vitamin D and / or fluoride salts, or any of the products known to affect bone metabolism
- •- subject who have received cyclins, digitalin, anti-anginal drugs, anti-arrrhythmic drugs, barbiturates, hydantoin, insulin, thiazides treatments within 2 weeks prior to the selection visit
- •- subject with a known allergy to the study medication or one of its constituents
- •- subject requiring regular or intermittent steroid therapy
- •- subjects with a body mass index (BMI) greater than 25
- •- subjects with past or current history of, or who showed evidence of any significant hematological, hepatic, gastrointestinal, genito-urinary, cardiac, vascular, respiratory, metabolic, endocrine, rheumatic, immune, allergic, neurological or psychiatric disease
- •- medical history of major medical, psychiatric illness or surgery which, in the judgment of the investigator, puts them ‘at risk’ or is likely to modify their handling of the study drug
- •- subject with any clinically significant condition, abnormality on physical examination or laboratory test results which, in the opinion of the investigator, could interfere with the interpretation of efficacy or safety data
- •- subject with a history of a disease which, according to the investigator, is liable to interfere with the study results or expose the patient to further risk
- •- subject having taken part in a clinical trial within 30 days prior the screening visit or taking part in a trial at the time of the screening visit
- •- subject who, in the judgment of the investigator, is not likely to be compliant during the study
- •- subject linguistically or psychologically unable to understand and sign the consent form
- •-subject who has forfeited his freedom by administrative or legal award, or who is under guardianship
- •-For women with childbearing potential
- •not using effective combined oral contraceptives
- •pregnant, breast feeding or likely to become pregnant during the time of thestudy
- •positive urinary pregnancy test
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