Quality of life in Japanese women with postmenopausal osteoporosis treated with raloxifene and vitamin D: post hoc analysis of a postmarketing study

Abstract

Objectives:

To assess the effect of active vitamin D₃ on quality of life (QOL) and pain in raloxifene-treated Japanese women with postmenopausal osteoporosis.

Research design and methods:

This is a post hoc analysis of a previous prospective postmarketing observational study conducted without a comparator group. This study was conducted in 60 Japanese hospitals from September 2007 to February 2009. We compared changes from baseline in QOL and pain in patients receiving raloxifene plus active vitamin D₃ with those in patients receiving raloxifene monotherapy at 8 and 24 weeks after treatment.

Clinical trial registration:

Japan Pharmaceutical Information Center (JapicCTI-070465).

Main outcome measures:

QOL and pain were assessed using Short Form-8 (SF-8), European Quality of Life Instrument 5 Dimensions (EQ-5D), Japanese Osteoporosis Quality of Life Questionnaire (JOQOL), visual analogue pain scales (VAS pain), and pain frequency scores.

Results:

A total of 506 patients were included in the post hoc analysis. Both raloxifene monotherapy (RLX, n = 354) and active vitamin D₃ cotreatment (COMBI, n = 152) significantly improved QOL and reduced pain from the baseline at Week 8 and Week 24. The COMBI group had significantly greater improvements in JOQOL total score and activity of daily living (total) domain at Week 24 and last observation carried forward (LOCF) than the RLX group. The COMBI group also had significantly greater improvements in SF-8 domains of general health (at Week 8, Week 24, and LOCF), role physical (at Week 24 and LOCF), and mental health (at LOCF) than the RLX group. The COMBI group also had significantly greater reduction in VAS pain at LOCF than the RLX group (mean [SD]: RLX = −0.99 [2.72], COMBI = −1.54 [2.21], P = 0.042).

Conclusions:

Active vitamin D₃ supplementation to raloxifene treatment for 24 weeks may have additional benefits in improving QOL and relieving pain in Japanese women with postmenopausal osteoporosis.

Keywords: :

• Japan
• Osteoporosis, postmenopausal
• Pain
• Quality of life
• Raloxifene
• Vitamin D

Transparency

Declaration of funding

This study was sponsored by Eli Lilly Japan KK, manufacturer of raloxifene. In collaboration with the authors, Eli Lilly Japan KK was involved in the study design, data collection, data analysis, and preparation of the manuscript.

Role of contributors: All authors participated in the interpretation of study results, and in the drafting, critical revision, and approval of the final version of the manuscript. H.O., E.H., and M.T. were involved in the study design. Statistical analysis was planned by M.T. and conducted by CMIC Co. Ltd.

Declaration of financial/other relationships

H.O. has disclosed that he has received consultant fees from Eli Lilly Japan KK and grant fees from Eisai Co. Ltd., Astellas Pharma Inc., and Teijin Pharma Ltd. E.H. has disclosed that he was an employee of Eli Lilly Japan KK during the study and the preparation of this manuscript, and is currently an employee at R&D Japan, Amgen Astellas Biopharm KK. M.T. and H.S. have disclosed that they are employees of Eli Lilly Japan KK. E.H. and H.S. have disclosed that they own stock in Eli Lilly and Company.

CMRO peer reviewers 1 and 2 have disclosed that they are on CMRO’s Editorial and International Advisory boards and have had past sponsorship and consultant relationships with numerous pharmaceutical companies. CMRO peer reviewer 3 has no relevant financial or other relationships to disclose.

Acknowledgements

The authors acknowledge the medical writing assistance provided by Ying Ke PhD and Rebecca Lew PhD CMPP of ProScribe, part of the Envision Pharma Group, funded by Eli Lilly Japan KK. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP2).

Notes

*Evista is a registered trade name of Eli Lilly and Company, Indianapolis, IN, USA