Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women

September 8, 2015 updated by: Instituto Palacios

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28009
        • Instituto Palacios
      • Madrid, Spain, 28001
        • Gabinete Médico Velázquez
      • Madrid, Spain, 28023
        • Instituto de Ginecología EGR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Conbriza
Drug: Calcium/Vit D
Calcium 500 mg / 400 IU Vit D
Other Names:
  • Ostine
Other: Calcium/Vit D
Calcium 500mg and 400 IU vitamin D (OSTINE )daily.
Drug: Calcium/Vit D
Calcium 500 mg / 400 IU Vit D
Other Names:
  • Ostine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lumbar Spine Bone Mineral Density (BMD)
Time Frame: 12 months
To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 and 12 months from baseline
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
6 and 12 months from baseline
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
6 and 12 months from baseline
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
12 months from baseline

Other Outcome Measures

Outcome Measure
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
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
At baseline, months 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Palacios

Collaborators

Pfizer

Investigators

  • Principal Investigator: Santiago Palacios, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

September 9, 2015

Last Update Submitted That Met QC Criteria

September 8, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP-2012-01
  • 2012-003131-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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