Issues

Fractures, back pain, quality of life, and compliance in German postmenopausal patients with osteoporosis treated with teriparatide

Journal: Osteologie
ISSN: 1019-1291
Topic:

Osteologische Biomaterialien

Issue: Issues of 2013 (Vol. 22): Issue 3 2013 (169-248)
Pages: 214-222

Fractures, back pain, quality of life, and compliance in German postmenopausal patients with osteoporosis treated with teriparatide

Subgroup analysis of the European Forsteo® Observational Study (EFOS)

S. Scharla (1), H. Oertel (2), H. Petto (3), F. Jakob (4)

(1) Praxis Innere Medizin und Endokrinologie/Diabetologie, Bad Reichenhall, Deutschland, und Medizinische Fakultät Ludwig-Maximilians-Universität München, Deutschland; (2) Lilly Deutschland GmbH, Medical Department, Bad Homburg, Deutschland; (3) Lilly Österreich GmbH, Wien, Österreich; (4) Universität Würzburg, Experimentelle und klinische Osteologie, Orthopädische Klinik König-Ludwig-Haus, Würzburg, Deutschland

Keywords

Osteoporosis, teriparatide, observational study, subgroup analysis Germany

Summary

Aim: The primary objective of the European Forsteo Observational Study (EFOS) was to analyze the incidence of clinical vertebral and non-vertebral fractures in postmenopausal women with osteoporosis treated with teriparatide for up to 18 months. The active treatment period was followed by an 18-month follow-up period, where up to 44.2 % of patients received other osteoporosis medications. In addition to the incidence of fractures, health related quality of life (EQ-5D and EQ-visual analogue scale [VAS]), back pain (incidence and severity of back pain, activity limitations due to back pain, VAS) and bone mineral density (T-score) were evaluated. Methods: Changes in the odds of fracture were analyzed in 6-month intervals using logistic regression with repeated measures and the changes in VAS scores were analyzed using a mixed model for repeated measures. Improvement/worsening from baseline in EQ-5D domains and in frequency and severity of patients with back pain were analyzed with the sign test. A total of 412 German patients participated in the EFOS study and 385 patients had evaluable data. Results:The median duration of teriparatide treatment was 542 days (Q1 = 515 days, Q3 = 562 days). The most important reasons for discontinuing teriparatide were patient’s decision and adverse events. A total of 44 patients (11.4 %) experienced 52 fractures (17 vertebral, 35 non-vertebral fractures) during the study. The odds of fractures were significantly reduced (from months 24 to < 30 onwards versus months 0 to < 6; odds ratio interval 24 to < 30 months versus 0 to < 6 months: 0.20 [95 % confidence interval, CI 0.05, 0.85], p-value 0.029; odds ratio interval 30 to < 36 months versus 0 to < 6 months: 0.11 [95 % CI 0.01, 0.83], p-value 0.032). The frequency and severity of back pain was reduced and the health related quality of life improved in all 5  domains (change from baseline to all time points statistically significant, p < 0.001). Conclusion: The results should be carefully interpreted in context of the observational study design.

You may also be interested in...

1.
S. Scharla

Die Medizinische Welt 2004 55 1: 5-

2.
Johannes Pfeilschifter

arthritis + rheuma 2004 24 1: 11-14

3.
S. v. Stengel, W. Kemmler, K. Engelke

Osteologie 2008 17 1: 24-30