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Comparison Between Raloxifene and Bazedoxifene

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ClinicalTrials.gov Identifier: NCT01973738
Recruitment Status : Unknown
Verified October 2016 by Toshihiko Kono, Tomidahama Hospital.
Recruitment status was:  Recruiting
First Posted : October 31, 2013
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Toshihiko Kono, Tomidahama Hospital

Brief Summary:
Although there are two kinds of selective estrogen receptor modulator (SERM) :raloxifene (RLX) and bazedoxifene (BZA), the difference is still unclear. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.

Condition or disease
Selective Estrogen Receptor Modulator

Detailed Description:

Selective estrogen receptor modulator (SERM) is an important option for postmenopausal osteoporosis. There are two SERM approved in Japan for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. One is raloxifene (RLX), and the other is bazedoxifene (BZA). There are few reports concerning to the clinical efficacy and safety data. In this study, we plan to compare clinical efficacy and safety between RLX and BZA.

The main objective of this study is to reveal the effects of RLX and BZA on bone mineral density, bone turnover markers, and bone quality markers.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of the Clinical Efficacy and Safety Between Raloxifene and Bazedoxifene in Postmenopausal Women.
Study Start Date : January 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Effects of raloxifene vs. bazedoxifene on bone mineral density, bone turnover markers and bone quality markers in postmenopausal osteoporosis. [ Time Frame: Up to 72 months ]

    The investigators plan to analyze 300 patients who undergo selective estrogen receptor modulator (SERM) treatments for five years.

    We investigate the efficacy of two SERMs: raloxifene (RLX) and bazedoxifene (BZA). Bone mineral density (BMD) andd laboratory analyses (bone markers, routine chemistry, urine, and bone quality marker of pentosidine) at baseline and every four to six months. We also investigate the side effects. Statical analyses are performed using Spearman correlation coefficients, paired t-test, Mann-Whitney U test, chi-square test and Fisher's exact test to compare the efficacy and safy between RLX and BZA.




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Ages Eligible for Study:   45 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Osteoporosis patients using SERM more for five years.
Criteria

Inclusion Criteria:

  • Postmenopausal women

Exclusion Criteria:

  • Patients who could not use SERM

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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): NCT01973738


Locations
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Japan
Tomidahama Hospital Recruiting
Yokkaichi, Mie, Japan, 510-8008
Contact: Rui Niimi, MD, PhD    (81)-59-365-0023    furikakefuri@hotmail.co.jp   
Sponsors and Collaborators
Toshihiko Kono

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Responsible Party: Toshihiko Kono, Head of Hospital, Tomidahama Hospital
ClinicalTrials.gov Identifier: NCT01973738     History of Changes
Other Study ID Numbers: IRB TH 05
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016

Keywords provided by Toshihiko Kono, Tomidahama Hospital:
raloxifene
bazedoxifene
bone mineral density
bone turnover markers
bone quality

Additional relevant MeSH terms:
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Raloxifene Hydrochloride
Bazedoxifene
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents