E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The Active substance of Osteopor is Ossein Hydroxyapatite. Treatment of processes characterized by decalcification: osteoporosis, Cushing syndrome, thyrotoxicosis. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006956 |
E.1.2 | Term | Calcium deficiency |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this study is to compare the effect of 4-week treatment with ossein-hydroxyapatite compound versus calcium carbonate on biochemical markers of bone resorption in young women with low calcium intake. |
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E.2.2 | Secondary objectives of the trial |
- To compare the effect of ossein-hydroxyapatite compound and calcium carbonate on : biochemical markers of bone formation calcium phosphorus homeostasis
To evaluate safety and tolerability of the studied products |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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. |
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E.4 | Principal exclusion criteria |
- 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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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |