Clinical Trial Results:
"Eficacia y seguridad de una administración oral diaria de S06911 (combinación fija de ranelato de estroncio 2g / vitamina D3 1000UI) en la deficiencia de vitamina D para el tratamiento de la osteoporosis en mujeres postmenopáusicas y hombres" Estudio internacional, de fase III, prospectivo, de 12 meses de duración en abierto con un grupo de tratamiento.
The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D deficiency in the treatment of osteoporotic postmenopausal women and men. A 12 month, prospective, open labelled, one treatment group international phase III study.
Summary
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EudraCT number |
2009-014270-18 |
Trial protocol |
ES BE DK SK PL |
Global completion date |
22 Jun 2011
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Dec 2016
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First version publication date |
10 Dec 2016
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Other versions |
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Summary report(s) |
Synopsis dated on 10-April-2010 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.