Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02090400 |
Recruitment Status :
Completed
First Posted : March 18, 2014
Last Update Posted : September 9, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis, Postmenopausal | Drug: Bazedoxifene Drug: Calcium/Vit D | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 110 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
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 |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Bazedoxifene & Calcium/Vit D
Bazedoxifene 20mg oral once a day and calcium 500mg and 400 IU vitamin D (OSTINE)
|
Drug: Bazedoxifene
20 mg Oral daily for 12 months
Other Name: Conbriza Drug: Calcium/Vit D Calcium 500 mg / 400 IU Vit D
Other Name: Ostine |
Calcium/Vit D
Calcium 500mg and 400 IU vitamin D (OSTINE )daily.
|
Drug: Calcium/Vit D
Calcium 500 mg / 400 IU Vit D
Other Name: Ostine |
- Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: 12 months ]To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)
- Bone Turnover Markers (BTM´s) carboxy-terminal collagen crosslinks (CTX) and 1 procollagen N-terminal (P1NP) [ Time Frame: 6 and 12 months from baseline ]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
- BMD at the femoral neck [ Time Frame: 6 and 12 months from baseline ]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
- BMD at total hip [ Time Frame: 6 and 12 months from baseline ]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
- Mammography [ Time Frame: 12 months from baseline ]Changes in Mammography at12 months from baseline in the Breast Imaging Report and Database System (BI-RADS) classification
- 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 [ Time Frame: At baseline, months 6 and 12 ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Ambulatory postmenopausal women 55 years or older at screening
- Have received daily, weekly or monthly oral bisphosphonates at least for 3 years and treatment change is indicated (not responses to bisphosphonates, for bad tolerability or for the potential risk of side effects in a long term treatment with bisphosphonates-indicated by Federal Drug Administration, European Medicines Agency.
- Subjects has stop bisphosphonates therapy no more than one month before screening visit for subjects in daily or weekly bisphosphonates
- Subjects has stop bisphosphonates therapy no more than two months before screening visit for subjects in monthly bisphosphonates
- Screening T-score at the lumbar spine ≤ -2.0 to -4.0 by Dual X ray Absorptiometry (DXA) scan
- At least 2 lumbar vertebrae must be evaluable by DXA
- Al least one hip must be evaluable by DXA (for secondary objectives)
Exclusion Criteria:
- Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- Current use of medication prescribed for osteoporosis other than oral bisphosphonates
- Subjects who had received intravenous bisphosphonates or fluoride (except for dental treatment)
- Subjects who had received any Selective Estrogens Receptor Modulator (SERM), anabolic steroids, systemic hormone replacement, calcitonin or calcitriol within 3 months.
- Subjects who had received strontium ranelate, parathyroid hormone (PTH) or PTH derivates within 1 year.
- Hyper or hypothyroidism, current hyper or hypoparathyroidism
- History of Venous Thromboembolism Event (VTE)
- Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less 35 mL/min
- Hyper or hypocalcemia
- Vitamin D deficiency (serum 25 (OH) vit D level < 20 ng/mL (< 50nmol/L)
- Any condition that could result in impaired calcium metabolism or metabolic bone disease that could interfere with interpretation findings

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): NCT02090400
Spain | |
Gabinete Médico Velázquez | |
Madrid, Spain, 28001 | |
Instituto Palacios | |
Madrid, Spain, 28009 | |
Instituto de Ginecología EGR | |
Madrid, Spain, 28023 |
Principal Investigator: | Santiago Palacios, MD |
Responsible Party: | Instituto Palacios |
ClinicalTrials.gov Identifier: | NCT02090400 |
Other Study ID Numbers: |
IP-2012-01 2012-003131-28 ( EudraCT Number ) |
First Posted: | March 18, 2014 Key Record Dates |
Last Update Posted: | September 9, 2015 |
Last Verified: | September 2015 |
Women Osteoporosis, Postmenopausal Bazedoxifene BMD |
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Bazedoxifene Calcium |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |