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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
110
20 mg Oral daily for 12 months
Calcium 500 mg / 400 IU Vit D
Gabinete Médico Velázquez
Madrid, Madrid, Spain
Instituto Palacios
Madrid, Madrid, Spain
Instituto de Ginecología EGR
Madrid, Madrid, Spain
Lumbar Spine Bone Mineral Density (BMD)
To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)
Time frame: 12 months
Bone Turnover Markers (BTM´s) carboxy-terminal collagen crosslinks (CTX) and 1 procollagen N-terminal (P1NP)
To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 International Units (IU) vitamin D (OSTINE) daily on BTM's CTX and P1NP
Time frame: 6 and 12 months from baseline
BMD at the femoral neck
To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 IU vitamin D (OSTINE) daily on BMD at the femoral neck
Time frame: 6 and 12 months from baseline
BMD at total hip
To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 IU vitamin D (OSTINE) daily on BMD at total hip
Time frame: 6 and 12 months from baseline
Mammography
Changes in Mammography at12 months from baseline in the Breast Imaging Report and Database System (BI-RADS) classification
Time frame: 12 months from baseline
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