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

Ö Ljunggren, C. L. Benhamou, J. Dekker, G. Kapetanos, T. Kocjan, B. L. Langdahl, N. Napoli, H. Petto, T. Nikolić, E. Lindh

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)1607-1616
Number of pages10
JournalCurrent Medical Research and Opinion
Volume30
Issue number8
DOIs
Publication statusPublished - 2014

Fingerprint

Teriparatide
Population Characteristics
Observational Studies
Back Pain
Osteoporosis
Femur Neck
Visual Analog Scale
Bone Density
Self Report
Glucocorticoids
Hip
Spine
Cohort Studies
Research Design
Thorax
Quality of Life
Outcome Assessment (Health Care)
Prospective Studies
Drug Therapy

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS). / Ljunggren, Ö; Benhamou, C. L.; Dekker, J.; Kapetanos, G.; Kocjan, T.; Langdahl, B. L.; Napoli, N.; Petto, H.; Nikolić, T.; Lindh, E.

In: Current Medical Research and Opinion, Vol. 30, No. 8, 2014, p. 1607-1616.

Research output: Contribution to journalArticle

Ljunggren, Ö, Benhamou, CL, Dekker, J, Kapetanos, G, Kocjan, T, Langdahl, BL, Napoli, N, Petto, H, Nikolić, T & Lindh, E 2014, 'Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)', Current Medical Research and Opinion, vol. 30, no. 8, pp. 1607-1616. https://doi.org/10.1185/03007995.2014.907561
Ljunggren, Ö ; Benhamou, C. L. ; Dekker, J. ; Kapetanos, G. ; Kocjan, T. ; Langdahl, B. L. ; Napoli, N. ; Petto, H. ; Nikolić, T. ; Lindh, E. / Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS). In: Current Medical Research and Opinion. 2014 ; Vol. 30, No. 8. pp. 1607-1616.
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AU - Benhamou, C. L.

AU - Dekker, J.

AU - Kapetanos, G.

AU - Kocjan, T.

AU - Langdahl, B. L.

AU - Napoli, N.

AU - Petto, H.

AU - Nikolić, T.

AU - Lindh, E.

PY - 2014

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N2 - 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.

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KW - Back pain

KW - Fractures

KW - Men

KW - Observational study

KW - Osteoporosis

KW - Quality of life

KW - Teriparatide

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