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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090400
• Other study ID #: IP-2012-01
• Secondary ID: 2012-003131-28
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2014
• Last updated: September 8, 2015
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Instituto Palacios
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Ministry of HealthSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Bazedoxifene
20 mg Oral daily for 12 months
• Calcium/Vit D
Calcium 500 mg / 400 IU Vit D

Locations

Country	Name	City	State
Spain	Gabinete Médico Velázquez	Madrid
Spain	Instituto de Ginecología EGR	Madrid
Spain	Instituto Palacios	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Palacios	Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	At baseline, months 6 and 12	No
Primary	Lumbar Spine Bone Mineral Density (BMD)	To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)	12 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Mammography	Changes in Mammography at12 months from baseline in the Breast Imaging Report and Database System (BI-RADS) classification	12 months from baseline	No