Clinical Trial Results:
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
Summary
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EudraCT number |
2008-002280-14 |
Trial protocol |
FR |
Global end of trial date |
13 Jan 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Dec 2018
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First version publication date |
28 Dec 2018
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
L00006 CP 403 3A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Pierre Fabre Médicament
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Sponsor organisation address |
45 place Abel Gance, Boulogne, France, 92654
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Public contact |
Dr Mohammed ZAÏM, Institut de Recherche Pierre Fabre (IRPF), +33 (0)5-34-50-61-91, mohammed.zaim@pierre-fabre.com
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Scientific contact |
Dr Mohammed ZAÏM, Institut de Recherche Pierre Fabre (IRPF), +33 (0)5-34-50-61-91, mohammed.zaim@pierre-fabre.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Jan 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Jan 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Jan 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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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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Protection of trial subjects |
The study was conducted according to Good Clinical Practice (GCP) (CPMP/ICH/135/95), the principles stated in the Declaration of Helsinki (1964) and its subsequent amendments thereto, and national regulations. The request for authorization by the Competent Authority or its notification (depending on National Regulations) was carried out by the Sponsor. The study protocol and related documents, including the informed consent forms (ICFs), were submitted for approval to independent, local or national Independent Ethics Committees (IECs) and to competent authorities (CAs) before the study set-up, according to national regulations.
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Background therapy |
No specific therapy was given during the study | ||
Evidence for comparator |
Calcium carbonate is considered to be a well bioavailable form of oral calcium. For the main efficacy criteria (biomarkers of resorption), a wash-out period of 4 weeks is considered sufficient to bring the values noted after the first treatment period back to baseline and thus avoid or minimise any possible carry-over effect. | ||
Actual start date of recruitment |
09 Sep 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 58
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Worldwide total number of subjects |
58
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EEA total number of subjects |
58
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
58
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 72 subjects were offered enrolment in the study. Of them, 12 were not randomised and 60 were effectively included and randomised. Premature withdrawal from therapy occurred in 2 subjects (not inculded in the FAS). | |||||||||
Pre-assignment
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Screening details |
72 young women with low calcium intake were offered enrolment. Low calcium intake is more frequent in young women than men. Moreover, osteoporosis is more prevalent amongst females than males. | |||||||||
Period 1
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Period 1 title |
Period 1
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Osteopor-Orocal | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Osteopor
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Investigational medicinal product code |
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Other name |
Ossein-hydroxyapatite, L0006
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Two tablets of 830 mg to be swallowed with a glass of tap water, twice daily in the morning and evening before meals for four weeks.
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Arm title
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Orocal-Osteopor | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Orocal
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Investigational medicinal product code |
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Other name |
Calcium carbonate
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
One tablet to be sucked twice daily in the morning and evening before meals for four weeks.
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Period 2
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Period 2 title |
Period 2
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Osteopor-Orocal | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Orocal
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Investigational medicinal product code |
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Other name |
Calcium carbonate
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
One tablet to be sucked twice daily in the morning and evening before meals for four weeks.
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Arm title
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Orocal-Osteopor | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Osteopor
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Investigational medicinal product code |
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Other name |
Ossein-hydroxyapatite, L0006
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Two tablets of 830 mg to be swallowed with a glass of tap water, twice daily in the morning and evening before meals for four weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Osteopor-Orocal
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Orocal-Osteopor
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Osteopor-Orocal
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Reporting group description |
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Reporting group title |
Orocal-Osteopor
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Reporting group description |
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Reporting group title |
Osteopor-Orocal
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Reporting group description |
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Reporting group title |
Orocal-Osteopor
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Reporting group description |
- |
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End point title |
Serum type-I collagen cross-linked C-telopeptide (CTX1) | ||||||||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The study main efficacy criterion was the change from baseline in serum concentration of the bone resorption biomarker CTX1 after 4 weeks of treatment.
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Statistical analysis title |
Full analysis set | ||||||||||||||||||||||||||||||
Comparison groups |
Osteopor-Orocal v Orocal-Osteopor
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Number of subjects included in analysis |
58
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.36 | ||||||||||||||||||||||||||||||
Method |
Test of the three effects of interest | ||||||||||||||||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were reported from subject's inclusion to the end of study. Any SAE occurring during the month following the last administration of the study drug or the
end of the study was to be notified to the Sponsor.
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Adverse event reporting additional description |
Any disease existing at subjects' selection was reported in the CRF. At each further visit (or phone call), the occurrence of AEs since the last visit was collected on the basis of subject’s spontaneous reporting, Investigator’s non-leading questioning and/or clinical assessments.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Osteopor-Orocal
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Orocal-Osteopor
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 3.3% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |