Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS).
The European Forsteo Observational Study was designed to examine the effectiveness of teriparatide in postmenopausal women with osteoporosis treated for up to 18 months in normal clinical practice in eight European countries. The incidence of clinical vertebral and nonvertebral fragility fractures, back pain, and health-related quality of life (HRQoL, EQ-5D) were assessed. Spontaneous reports of adverse events were collected. All 1,648 enrolled women were teriparatide treatment-naive, 91.0% of them had previously received other anti-osteoporosis drugs, and 72.8% completed the 18-month study. A total of 168 incident clinical fractures were sustained by 138 (8.8%) women (821 fractures/10,000 patient-years). A 47% decrease in the odds of fracture in the last 6-month period compared to the first 6-month period was observed (P < 0.005). Mean back pain VAS was reduced by 25.8 mm at end point (P < 0.001). Mean change from baseline in EQ-VAS was 13 mm by 18 months. The largest improvements were reported in the EQ-5D subdomains of usual activities and pain/discomfort. There were 365 adverse events spontaneously reported, of which 48.0% were considered related to teriparatide; adverse events were the reason for discontinuation for 79 (5.8%) patients. In conclusion, postmenopausal women with severe osteoporosis who were prescribed teriparatide in standard clinical practice had a significant reduction in the incidence of fragility fractures and a reduction in back pain over an 18-month treatment period. This was associated with a clinically significant improvement in HRQoL. Safety was consistent with current prescribing information. These results should be interpreted in the context of the open-label, noncontrolled design of the study.
Langdahl
Bente L
BL
Department of Endocrinology, Arhus University Hospital, Tage Hansens Gade 2, Arhus, 8000, Denmark. bente.langdahl@aarhus.rm.dk
Rajzbaum
Gerald
G
Jakob
Franz
F
Karras
Dimitrios
D
Ljunggren
Osten
O
Lems
Willem F
WF
Fahrleitner-Pammer
Astrid
A
Walsh
J Bernard
JB
Barker
Clare
C
Kutahov
Alexey
A
Marin
Fernando
F
D000368:Aged; D001416:Back Pain / Q000453:epidemiology / Q000517:prevention & control*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D005060:Europe; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D015663:Osteoporosis, Postmenopausal / Q000150:complications* / Q000188:drug therapy*; D010147:Pain Measurement; D011788:Quality of Life; D019379:Teriparatide / Q000627:therapeutic use*; D013997:Time Factors
D050071:Bone Density Conservation Agents; D019379:Teriparatide