Osteoporosis, Postmenopausal Clinical Trial
Official title:
Multi-centre, Randomized, Open Label Trial to Evaluate the Effects of Switching to Bazedoxifene in Comparison With Switching to Calcium and Vitamin D in Postmenopausal Women Previously Treated With Bisphosphonates
The aim of this study is see the changes in bone mineral density after discontinuation or stop the use of bisphosphonates and make the switch to bazedoxifene).
The primary hypothesis is: "Comparing to control group (Calcium+VitD), Bazedoxifene group
(20mg daily+ calcium+VitD) is efficient in reducing BMD in spine at 12 months of treatment.
in postmenopausal women switching from daily, weekly or monthly bisphosphonates therapy. It
is a non-inferiority study of Bazedoxifene compared to biphosphonates, being each patient
its own control from the baseline. It is a superiority study of Bazedoxifene compared to
Calcium+VitD.
Taking into account the difference in the percentage change observed in the total BMD of the
spine during 12 months in those patients treated with Bazedoxifene+Ca+VitD at least 110
patients should be included, 55 in each arm of treatment.
This simple size is going to allow us to detect the differences in the percentage change
observed in the total BMD of the spine during 12 months between the two treatment arms,
being the same or over 0.25%, with a significance level of 95%, an 80% power. It is
estimated a standard deviation of 0.5%, and a 10% lost follow-up rate.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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