Postmenopausal women with osteoporosis: experience when treated with teriparatide in clinical practice

Abstract

Objective:

To observe and compare back pain and health-related quality of life (HRQoL) in postmenopausal women with a prior unsatisfactory response to antiresorptive therapy, treated with teriparatide (TPTD) or alternative treatments in normal clinical practice.

Research design and methods:

Prospective, observational, multicentre, 24-month study of postmenopausal women with osteoporosis. A back pain and HRQoL questionnaire (European Quality of Life Questionnaire, EQ-5D) including visual analogue scale (VAS) was completed at each visit.

Results:

A total of 153 patients were enrolled, 105 patients started TPTD treatment during the study (TPTD cohort) and 48 patients did not take TPTD treatment at any time during the study (non-TPTD cohort). Four patients did not meet the inclusion criteria for the study. Of the patients in the non-TPTD cohort, 31 (68.9%) took antiresorptives during the study. The patients selected by the investigator for teriparatide treatment were distinctly different from those not selected. At baseline, the mean back pain VAS was greater in the TPTD than the non-TPTD cohort, 64 mm and 42 mm, respectively (p < 0.001). During the study, compared with baseline, the mean back pain VAS decreased in the TPTD cohort at all visits (p < 0.001). In the non-TPTD cohort, a transitory decrease in the mean after 12 months was observed (−10 mm, p = 0.023) only. After 24 months, the mean back pain VAS improved in the TPTD cohort (−36 mm, p < 0.001) while no change was observed in the non-TPTD cohort (−4 mm, p = 0.467). At baseline, the mean EQ-VAS was lower in the TPTD than in the non-TPTD cohort, 40.8 and 55.2, respectively (p < 0.001). After 24 months, EQ-VAS improved in both cohorts (TPTD 34, p < 0.001 and non-TPTD 9, p = 0.026).

Conclusions:

TPTD-treated patients had more back pain and lower HRQoL at baseline. In the TPTD cohort the mean value was consistently and significantly improved in back pain and quality of life. In the non-TPTD cohort, the mean improvement in back pain and QoL was inconsistent possibly due to the initially higher QoL and lower back pain leaving less room for improvement. These results should be interpreted in the context of limitations related to a non-randomised observational study.

Key words::

• Back pain
• Health-related quality of life (HRQoL)
• Osteoporosis
• Postmenopausal women
• Teriparatide (TPTD)

Transparency

Declaration of funding

Funding for this study was provided by Eli Lilly and Company.

Declaration of financial/other relationships

S.I-S. has disclosed that she has received research grants and consultancy honoraria from Lilly. I.P. and C.B. have disclosed that they are full-time employees of Lilly. I.P. reports ownership of Lilly stock. All other authors report no conflicts of interest.

Acknowledgements

Investigators: S. Ish-Shalom, Rambam Medical Center – Haifa, Israel; R. Pollak, Hadassah Medical Center – Jerusalem, Israel; G. Tsvetov, Rabin Medical Center – Petach Tiqua, Israel; N. Shasha, Tel Aviv Medical Center – Tel Aviv, Israel; C. Dumitrache, C.I. Parhon Institute – Bucharest, Romania; A. Hussein, Suliman Fakih Hospital – Jeddah, Saudi Arabia; F. Al Sabaan, Riyadh Kharj Hospital – Riyadh, Saudi Arabia; M. Hanafy Salama, Saudi German Hospital – Jeddah, Saudia Arabia; Y.A. Naaman, Private – Saudi Ailines, Jeddah, Saudi Arabia; M.A. Azzab, Dr Soliman Fakin Hospital – Jeddah, Saudi Arabia; T. El-Husseini, Private Clinic – Cairo, Egypt; M. Balbaa, Private Clinic – Alexandria, Egypt; Y. El Hawary, Private Clinic – Cairo, Egypt.

Some data were presented previously in form of an abstract and a poster by Ish-Shalom S. et al. at the 36th Symposium on Calcified Tissues, Vienna, Austria, May 23–27, 2009.