Comparison Between Raloxifene and Bazedoxifene

Selective Estrogen Receptor Modulator Clinical Trial

Official title:

Comparison of the Clinical Efficacy and Safety Between Raloxifene and Bazedoxifene in Postmenopausal Women.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01973738
• Other study ID #: IRB TH 05
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2013
• Last updated: October 18, 2016
• Start date: January 2012
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Tomidahama Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 100 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women

Exclusion Criteria:

• Patients who could not use SERM

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Selective Estrogen Receptor Modulator

Locations

Country	Name	City	State
Japan	Tomidahama Hospital	Yokkaichi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
Toshihiko Kono

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of raloxifene vs. bazedoxifene on bone mineral density, bone turnover markers and bone quality markers in postmenopausal osteoporosis.	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.	Up to 72 months	Yes