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Hormones

, Volume 17, Issue 4, pp 531–540 | Cite as

Conducting an observational study during an economic crisis: analysis of the treatment and follow-up phase of Greek patients participating in the ExFOS study

  • Kyriakos Aloumanis
  • G. Kapetanos
  • T. Alexandridis
  • V. Drossinos
  • N. Papaioannou
  • for the Greek ExFOS study group
Original Article
  • 57 Downloads

Abstract

Objective

We present the subanalysis of the Greek cohort of the Extended Forsteo Observational Study (ExFOS), a multicenter, non-interventional, prospective, observational study evaluating the effect of teriparatide on fractures, back pain (BP), health-related quality of life (HR-QoL), and safety and compliance, in patients with osteoporosis treated for up to 24 months, with a post-treatment follow-up of at least 18 months.

Design

A total of 439 osteoporotic patients (92.2% female) were enrolled in Greece. New or worsened fractures, based on their physicians’ assessment, as well as patients’ self-assessment of HR-QoL and BP, compliance, and safety profile, were captured by validated questionnaires.

Results

In the ExFOS Greek cohort, fracture rates were low and mean bone mineral density (BMD) was numerically improved. Compliance with teriparatide remained high throughout the study, with 81.5% of subjects completing treatment. Only 0.7% of patients reported discontinuation due to adverse effects. A sustainable improvement in patient-perceived BP and HRQoL throughout treatment and follow-up was similar to that achieved by the European Forsteo Observational Study (EFOS). A lower than expected percentage of patients using antiresorptives following teriparatide was recorded.

Conclusions

ExFOS reproduces the outcomes of EFOS, with a 6.5-year time interval between studies, in comparable cohorts of osteoporotic patients. Data should be interpreted in the context of observational study data collection, although summary statistics computed at each time point may overstate drug effect.

Keywords

Osteoporosis Teriparatide Back pain Quality of life Fractures 

Notes

Acknowledgments

We extend our thanks to the Greek ExFOS Study Group: Adam A, Alexandridis T, Athanasakopoulos P, Dimopoulos N, Dionyssiotis Y, Georgountzos A, Giannadakis P, Gkouvas G, Kapetanos G, Kaplanoglou T, Karagiannis A, Kleisiounis A, Kokkoris P, Kosmidis C, Kossyvakis K, Krallis N, Matsouka A, Matzaroglou C, Meleteas E, Milonas C, Mpintas S, Papaioannou N, Papazisis Z, Repousis AP, Savvidis M, Temekonidis T, Trovas G, Tsakiri V, Tzoitou M, Tzoutzopoulos A, Vandoros G, Ziambaras K.

The authors wish to thank Christopher Jeremy Child PhD, Research Advisor—Endocrinology for editing the manuscript.

Compliance with ethical standards

Disclaimer

KA and VD are employees of Pharmaserve-Lilly SACI.

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Copyright information

© Hellenic Endocrine Society 2018

Authors and Affiliations

  • Kyriakos Aloumanis
    • 1
  • G. Kapetanos
    • 2
  • T. Alexandridis
    • 3
  • V. Drossinos
    • 1
  • N. Papaioannou
    • 4
  • for the Greek ExFOS study group
  1. 1.Department of Medical ResearchPharmaserve LillyKifissiaGreece
  2. 2.Papageorgiou General Hospital3rd Orthopedics University ClinicThessalonikiGreece
  3. 3.Endocrine Division, Department of MedicinePatras University HospitalPatrasGreece
  4. 4.Musculoskeletal Diseases Research LaboratoryAthens General Hospital “KAT”KifissiaGreece

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