Comparison Between Raloxifene and Bazedoxifene

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01973738

Enrollment

300

Registered

2013-10-31

Start date

2012-01-31

Completion date

2018-12-31

Last updated

2016-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selective Estrogen Receptor Modulator

Keywords

raloxifene, bazedoxifene, bone mineral density, bone turnover markers, bone quality

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Postmenopausal women

Exclusion criteria

* Patients who could not use SERM

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Japan

Outcome results