Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)

Abstract

Objective:

To better characterize patients who are currently being prescribed teriparatide in Europe, this article describes the study design and baseline characteristics of participants of the Extended Forsteo Observational Study (ExFOS).

Research design and methods:

ExFOS is a noninterventional, multicenter, prospective, observational study in men and women with osteoporosis treated with teriparatide during the course of normal clinical practice for up to 24 months and with a post-treatment follow-up of at least 18 months.

Main outcome measures:

Baseline characteristics, including history of fracture and back pain, and health-related quality of life (HRQoL, assessed using the EuroQol-5 Dimension [EQ-5D]).

Results:

Of 1607 patients enrolled, 90.9% were women. At baseline, mean (standard deviation [SD]) age was 70.3 (9.8) years, and 85.8% of patients had a history of fracture (64.7% with ≥2 fragility fractures). Of those with historic fractures, 90.8% had vertebral fractures (67.8% had thoracic fractures). The mean (SD) of reported bone mineral density T-scores were −3.0 (1.2), −2.4 (1.0), and −2.5 (0.9) for lumbar spine, total hip (left), and femoral neck (left), respectively. Overall, 39.3% of patients had experienced ≥1 fall during the 12 months before enrollment. At baseline, 11.4% of patients were osteoporosis-treatment naïve and 15% were currently using glucocorticoids. The mean (SD) visual analog scale score for back pain during the last month was 50.7 (26.9), and 62.1% of patients experienced daily or almost daily back pain. The median EQ-5D health state value at baseline was 0.62 (first and third quartiles: 0.19, 0.74).

Conclusions:

Baseline characteristics of the ExFOS study cohort indicate that patients prescribed teriparatide in Europe have severe osteoporosis with highly prevalent vertebral fractures, frequent and disabling back pain, and a poor HRQoL, despite previous pharmacotherapy for osteoporosis. Limitations include non-randomization, lack of a comparator group, and patient self-report for data on prior medication and fracture history.

Keywords::

• Back pain
• Fractures
• Men
• Observational study
• Osteoporosis
• Quality of life
• Teriparatide

Transparency

Declaration of funding

This study was sponsored by Eli Lilly and Company. The study sponsor participated in the data analysis.

Declaration of financial/other relationships

E.L. and H.P. have disclosed that they are employees of Eli Lilly and Company. O.L. has disclosed that she/he has received lecture fees from Eli Lilly and Amgen and has participated in clinical trials for Eli Lilly, Amgen and Merck. C.L.B. has disclosed that she/he has received research funding from Amgen, Servier, and Merck, and serves on advisory boards and speakers’ bureaus for Amgen, Servier, Roche, Rottapharm, Novartis, and Merck. J.D. and G.K. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. T.K. has disclosed that she/he serves on advisory boards and speakers’ bureaus for Eli Lilly, Amgen, and Servier. B.L.L. has disclosed that she/he has received research funding from and serves on advisory boards and speakers’ bureaus for Eli Lilly, Amgen, and Merck. N.N. has disclosed that she/he has received consulting fees from Eli Lilly and Merck. T.N. has disclosed that she/he has been the primary investigator in clinical trials for Eli Lilly and Merck, has served on advisory boards for Eli Lilly, and has been a speaker for Eli Lilly, Merck, Servier, Berlin-Chemie Manarini, FidiFarm, and Pliva.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank Thomas Moll (European Union Clinical Operations, Eli Lilly and Company) for his contribution in the coordination, conduct, and analysis of the study. Deirdre Elmhirst and Caroline Spencer (Rx Communications, UK) provided medical writing assistance, funded by Eli Lilly and Company.

Previous presentation: Preliminary results of this work were presented at the European Calcified Tissue Society Annual Congress 2013, Lisbon, 18–21 May 2013. Available at: http://www.bone-abstracts.org/ba/0001/ba0001pp429.htm.

Notes

*Forsteo is a registered trade name of Eli Lilly and Company

*Forsteo is a registered trade name of Eli Lilly and Company