Effect of Alendronate 70mg Formulation on Bone Turnover Markers and Patient Reported Outcomes
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|ClinicalTrials.gov Identifier: NCT03435094|
Recruitment Status : Unknown
Verified February 2018 by Labatec Pharma SA.
Recruitment status was: Not yet recruiting
First Posted : February 15, 2018
Last Update Posted : February 23, 2018
|Condition or disease||Intervention/treatment|
|Osteoporosis, Postmenopausal||Drug: Binosto 70Mg Effervescent Tablet Drug: Fosamax 70Mg Tablet|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||A Non-interventional Two-arm Two-centre, Retrospective/Prospective Study to Compare the Effect of Alendronate 70mg Formulation (Tablet vs Effervescent Tablet) on Bone Turnover Markers and Patient Reported Outcomes|
|Estimated Study Start Date :||February 25, 2018|
|Estimated Primary Completion Date :||August 1, 2019|
|Estimated Study Completion Date :||August 1, 2019|
1 group will be treated with alendronate 70 mg tablets (Fosamax®)
Drug: Fosamax 70Mg Tablet
Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.
1 group will be treated with alendronate 70 mg effervescent tablets for buffered solution (Binosto®)
Drug: Binosto 70Mg Effervescent Tablet
Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.
- s-CTX [ Time Frame: Change at 6 months, 12 months, 18 months after treatment start ]Decrease in the rate of the bone resorption marker s-CTX
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435094
|Contact: Aurélie TIREFORD, PharmD||+41 22 593 78 email@example.com|
|Endokrinologische Praxis & Labor|
|Basel, BS, Switzerland, 4055|
|Contact: Christian Meier, Prof|
|Hôpital Universitaire de Genève, Service des maladies osseuses|
|Genève, GE, Switzerland, 1211|
|Contact: Serge Ferrari, Prof|
|Study Director:||Aurélie TIREFORD, PharmD||Labatec Pharma SA|