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

• ClinicalTrials.gov Identifier: NCT02090400
• Recruitment Status: Completed
• First Posted: March 18, 2014
• Last Update Posted: September 9, 2015
• Sponsor: Instituto Palacios
• Collaborator: Pfizer
• Information provided by (Responsible Party): Instituto Palacios

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 (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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Lumbar Spine Bone Mineral Density (BMD) [ Time Frame: 12 months ]
   To evaluate the change in Lumbar Spine Bone Mineral Density (BMD)

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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

Other Outcome Measures:

1. 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

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Spain

Gabinete Médico Velázquez

Madrid, Spain, 28001

Instituto Palacios

Madrid, Spain, 28009

Instituto de Ginecología EGR

Madrid, Spain, 28023

Sponsors and Collaborators

Instituto Palacios

Pfizer

Investigators

• Principal Investigator: Santiago Palacios, MD

More Information

• 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
• Last Update Posted: September 9, 2015
• Last Verified: September 2015

Keywords provided by Instituto Palacios:

Women; Osteoporosis, Postmenopausal; Bazedoxifene; BMD

Additional relevant MeSH terms:

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