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

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

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.

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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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Santiago Palacios, MD
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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
Keywords provided by Instituto Palacios:
Women
Osteoporosis, Postmenopausal
Bazedoxifene
BMD
Additional relevant MeSH terms:
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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