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

NCT02090400

Last updated date
Study Location
Gabinete Médico Velázquez
Madrid, , 28001, Spain
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmenopausal Osteoporosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Postmenopausal OsteoporosisSwitching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women
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Advanced Information
Descriptive Information
Brief Title  ICMJE Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women
Official Title  ICMJE 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
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Osteoporosis, Postmenopausal
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Bazedoxifene & Calcium/Vit D
    Bazedoxifene 20mg oral once a day and calcium 500mg and 400 IU vitamin D (OSTINE)
    Interventions:
    • Drug: Bazedoxifene
    • Drug: Calcium/Vit D
  • Calcium/Vit D
    Calcium 500mg and 400 IU vitamin D (OSTINE )daily.
    Intervention: Drug: Calcium/Vit D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2014)
110
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02090400
Other Study ID Numbers  ICMJE IP-2012-01
2012-003131-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto Palacios
Study Sponsor  ICMJE Instituto Palacios
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Santiago Palacios, MD
PRS Account Instituto Palacios
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP