Study description and baseline characteristics of the population enrolled in a multinational, observational study of teriparatide in postmenopausal women with osteoporosis: the Asia and Latin America Fracture Observational Study (ALAFOS)

Abstract

Objective: To describe the study design and baseline patient characteristics of the Asia and Latin America Fracture Observational Study (ALAFOS) to better understand the profile of patients receiving teriparatide during the course of routine clinical practice in Asia, Latin America, the Middle East and Russia.

Methods: Prospective, observational, non-interventional study in postmenopausal women with osteoporosis who are prescribed teriparatide for up to 24 months, according to local medical standards, with a 12 month post-treatment follow-up.

Measures: Demographics, risk factors for osteoporosis and fractures, history of fracture, prior osteoporosis medications, comorbidities, physical function, back pain and quality of life (QoL).

Results: In total 3031 postmenopausal women (mean age 72.5 years) recruited at 152 sites in 20 countries were analyzed; 62.9% had a history of fragility fracture after age 40 (33.0% of patients with spinal, 14.2% with hip fractures). The mean (SD) bone mineral density T-scores at baseline were −3.06 (1.40) and −2.60 (1.05) at the lumbar spine and femoral neck, respectively. At entry, 43.7% of patients were naïve to prior osteoporosis treatments; 40.5% of patients reported ≥1 fall in the past year. The median (Q1; Q3) EuroQoL Visual Analog Scale (EQ-VAS) for perceived overall health status was 60 (50; 80). The mean (SD) worst back pain Numeric Rating Scale in the last 24 hours was 4.6 (3.3).

Conclusions: Our data indicates that patients who were prescribed teriparatide in the ALAFOS participant countries had severe osteoporosis, high prevalence of fractures, disabling back pain and poor QoL. The frequency of patients receiving prior osteoporosis medications was lower than in previous observational studies conducted in other locations.

Keywords:

• Fractures
• observational study
• osteoporosis
• teriparatide

Transparency

Declaration of funding

Eli Lilly and Company sponsored the ALAFOS study (unique study identifier: B3D-MC-B026).

Author contributions: S.G. and R.T.B. were involved in the conception and design of the study. T.M. contributed to the design of the study. All authors were involved in analysis and interpretation of the data, drafting of the paper or revising it critically for intellectual content. All authors have approved the version to be published and agree to be accountable for all aspects of the work.

Declaration of financial/other relationships

S.I.-S. has disclosed that she has received grant support, consulting and lecture fees from Eli Lilly. J.L.C.-B. has disclosed that he has received lecture fees from Eli Lilly. The following authors did not report any conflict of interest related with the current manuscript: C.-H.C., A.H.E., S.-J.L., N.S.A.-A., H.Y., N.C. and L.A. T.M., S.G., A.J.M.B., R.T.B. and F.M. have disclosed that they are employees of Eli Lilly and Company.

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

Previous presentation: Preliminary results of this study were presented at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases 2018, Krakow, Poland, 19–22 April 2018.

Data availability statement: The data that supports the findings of this study is available from the corresponding author, F.M., upon reasonable request.

Acknowledgements

The authors thank Sheetal Pradhan (MD) of Eli Lilly and Company for providing medical writing support.

Notes

* Following Reed and Mitchell (2003), I use the concept “gender taxonomy” to describe the process of counting and making gender differences in representation visible.