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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2008-002280-14-FR |
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Date of registration:
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06/06/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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18/07/2008 |
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Target sample size:
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60 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002280-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Key inclusion & exclusion criteria
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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.
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
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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
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Health Condition(s) or Problem(s) studied
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The Active substance of Osteopor is Ossein Hydroxyapatite.
Treatment of processes characterized by decalcification: osteoporosis, Cushing syndrome, thyrotoxicosis.
MedDRA version: 9.1
Level: LLT
Classification code 10006956
Term: Calcium deficiency
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Intervention(s)
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Trade Name: OSTEOPOR
Product Name: OSTEOPOR
Product Code: L0006CP03A
Pharmaceutical Form: Tablet
INN or Proposed INN: ossein hydroxyapatite
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 830-
Trade Name: OROCAL
Product Name: OROCAL
Pharmaceutical Form: Tablet
INN or Proposed INN: calcium carbonate
CAS Number: 471341
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
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Primary Outcome(s)
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Secondary Objective: - 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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Primary end point(s): Efficacy
Safety
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Main Objective: 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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Secondary ID(s)
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L00006 CP 403 3A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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