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
|Condition or disease|
|Selective Estrogen Receptor Modulator|
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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|Observational Model:||Case Control|
|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|
- 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.
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
|Yokkaichi, Mie, Japan, 510-8008|
|Contact: Rui Niimi, MD, PhD (81)-59-365-0023 email@example.com|