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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003131-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bazedoxifene & Calcium/Vit D | Other | Bazedoxifene 20mg oral once a day and calcium 500mg and 400 IU vitamin D (OSTINE) |
|
| Calcium/Vit D | Other | Calcium 500mg and 400 IU vitamin D (OSTINE )daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bazedoxifene | Drug | 20 mg Oral daily for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar Spine Bone Mineral Density (BMD) | To evaluate the change in Lumbar Spine Bone Mineral Density (BMD) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 and 12 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Subject reported treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM) and gastrointestinal symptoms using the Gastrointestinal Symptoms Rating Scale (GSRS)the Spanish versions | To evaluate the effects of switching to Bazedoxifene 20mg in comparison with switching to calcium 500mg and 400 IU vitamin D (OSTINE)daily on Subject reported treatment satisfaction using the Treatment Satisfaction Questionnaire for Medication (TSQM) and gastrointestinal symptoms using the Gastrointestinal Symptoms Rating Scale (GSRS)the Spanish versions |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Palacios, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabinete Médico Velázquez | Madrid | Madrid | 28001 | Spain | ||
| Instituto Palacios |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C447119 | bazedoxifene |
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| Calcium/Vit D | Drug | Calcium 500 mg / 400 IU Vit D |
|
|
| 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 |
| 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 | 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 | 12 months from baseline |
| At baseline, months 6 and 12 |
| Madrid |
| Madrid |
| 28009 |
| Spain |
| Instituto de Ginecología EGR | Madrid | Madrid | 28023 | Spain |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |