Comparison Between Raloxifene and Bazedoxifene

• Conditions: Selective Estrogen Receptor Modulator

• Registration Number: NCT01973738
• Lead Sponsor: Toshihiko Kono

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.

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-31
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Postmenopausal women

Exclusion Criteria

• Patients who could not use SERM

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects of raloxifene vs. bazedoxifene on bone mineral density, bone turnover markers and bone quality markers in postmenopausal osteoporosis.	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.

Trial Locations

Locations (1)

Tomidahama Hospital; 🇯🇵 Yokkaichi, Mie, Japan