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

Sponsor

Instituto Palacios (Other)

Overall Status

Completed

CT.gov ID

NCT02090400

Collaborator

Pfizer (Industry)

110

Enrollment

Locations

Arms

Duration (Months)

36.7

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis, Postmenopausal	Drug: Bazedoxifene Drug: Calcium/Vit D	Phase 4

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 Design

Study Type:

Interventional

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 1, 2013

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Lumbar Spine Bone Mineral Density (BMD) [12 months]
To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)

Secondary Outcome Measures

Bone Turnover Markers (BTM´s) carboxy-terminal collagen crosslinks (CTX) and 1 procollagen N-terminal (P1NP) [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 [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 [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 [12 months from baseline]
Changes in Mammography at12 months from baseline in the Breast Imaging Report and Database System (BI-RADS) classification

Other Outcome Measures

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]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

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