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)

References

• NIH Consensus Development Panel on Osteoporosis Prevention Diagnosis and Therapy. Osteoporosis prevention, diagnosis and therapy. JAMA. 2001;285:785–795.
   PubMed Web of Science ®Google Scholar
• Lips P, van Schoor NM. Quality of life in patients with osteoporosis. Osteoporos Int. 2005;16:447–455.
   PubMed Web of Science ®Google Scholar
• Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006;17:1726–1733.
   PubMed Web of Science ®Google Scholar
• Cooper C, Campion G, Melton LJ. Hip fractures in the elderly: a world-wide projection Osteoporos Int. 1992;2:285–289.
   PubMed Web of Science ®Google Scholar
• Riggs BL, Parfitt AM. Drugs used to treat osteoporosis: the critical need for a uniform nomenclature based on their action on bone remodeling. J Bone Miner Res. 2005;20:177–184.
   PubMed Web of Science ®Google Scholar
• Seeman E, Delmas PD. Bone quality – the material and structural basis of bone strength and fragility. N Engl J Med. 2006;354:2250–2261.
   PubMed Web of Science ®Google Scholar
• Eli Lilly and Company. Teriparatide. Prescribing Information [Internet]. 2012 [cited 2018 Jun 26]. Available from: https://pi.lilly.com/us/forteo-pi.pdf
   Google Scholar
• Eli Lilly and Company. Teriparatide. Summary of Product Characteristics [Internet]. 2017 [cited 2018 Jun 26]. Available from: https://www.medicines.org.uk/emc/product/2215/smpc
   Google Scholar
• Jiang Y, Zhao JJ, Mitlak BH, et al. Recombinant human parathyroid hormone (1-34) [teriparatide] improves both cortical and cancellous bone structure. J Bone Miner Res. 2003;18:1932–1941.
   PubMed Web of Science ®Google Scholar
• Lindsay R, Krege JH, Marin F, et al. Teriparatide for osteoporosis: importance of the full course. Osteoporos Int. 2016;27:2395–2410.
   PubMed Web of Science ®Google Scholar
• Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344:1434–1441.
   PubMed Web of Science ®Google Scholar
• Kendler DL, Marin F, Zerbini CAF, et al. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2018;391:230–240.
   PubMed Web of Science ®Google Scholar
• Fahrleitner-Pammer A, Langdahl BL, Marin F, et al. Fracture rate and back pain during and after discontinuation of teriparatide: 36-month data from the European Forsteo Observational Study (EFOS). Osteoporos Int. 2011;22:2709–2719.
   PubMed Web of Science ®Google Scholar
• Napoli N, Langdahl BL, Ljunggren Ö, et al. Effects of teriparatide in patients with osteoporosis in clinical practice: 42-month results during and after discontinuation of treatment from the European Extended Forsteo Observational Study (ExFOS). Calcif Tissue Int. 2018;103(4):359–371.
   Web of Science ®Google Scholar
• Silverman S, Miller P, Sebba A, et al. The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study: 2-year nonvertebral fragility fracture results. Osteoporos Int. 2013;24:2309–2317.
   PubMed Web of Science ®Google Scholar
• Soen S, Fujiwara S, Takayanagi R, et al. Real-world effectiveness of daily teriparatide in Japanese patients with osteoporosis at high risk for fracture: final results from the 24-month Japan Fracture Observational Study (JFOS). Curr Med Res Opin. 2017;33:2049–2056.
   PubMed Web of Science ®Google Scholar
• Breuil V, Cortet B, Cotte FE, et al. Validation of the adherence evaluation of osteoporosis treatment (ADEOS) questionnaire for osteoporotic post-menopausal women. Osteoporos Int. 2012;23:445–455.
   PubMed Web of Science ®Google Scholar
• Callahan LF, Brooks RH, Pincus T. Further analysis of learned helplessness in rheumatoid arthritis using a “Rheumatology Attitudes Index”. J Rheumatol. 1988;15:418–426.
   PubMed Web of Science ®Google Scholar
• Solomon DH, Brookhart MA, Tsao P, et al. Predictors of very low adherence with medications for osteoporosis: towards development of a clinical prediction rule. Osteoporos Int. 2011;22:1737–1743.
   PubMed Web of Science ®Google Scholar
• Brooks R. EuroQol: the current state of play. Health Policy. 1996;37:53–72.
   PubMed Web of Science ®Google Scholar
• Naegeli AN, Nixon A, Burge R, et al. Development of the Osteoporosis Assessment Questionnaire–Physical Function (OPAQ-PF): an osteoporosis-targeted, patient-reported outcomes (PRO) measure of physical function. Osteoporos Int. 2014;25:579–588.
   PubMed Web of Science ®Google Scholar
• Nixon A, Kerr C, Doll H, et al. Osteoporosis Assessment Questionnaire–Physical Function (OPAQ-PF): a psychometrically validated osteoporosis-targeted patient reported outcome measure of daily activities of physical function. Osteoporos Int. 2014;25:1775–1784.
   PubMed Web of Science ®Google Scholar
• Hwang JS, Chan DC, Chen JF, et al. Clinical practice guidelines for the prevention and treatment of osteoporosis in Taiwan: summary. J Bone Miner Metab. 2014;32:10–16.
   PubMed Web of Science ®Google Scholar
• OSHK Task Group. The Osteoporosis Society of Hong Kong (OSHK): 2013 OSHK guideline for clinical management of postmenopausal osteoporosis in Hong Kong. Hong Kong Med J. 2013;19(Suppl 2):1–40.
   Web of Science ®Google Scholar
• Yeap SS, Hew FL, Lee JK, et al. The Malaysian clinical guidance on the management of postmenopausal osteoporosis, 2012: a summary. Int J Rheum Dis. 2013;16:30–40.
   PubMed Web of Science ®Google Scholar
• Members of the Iberoamerican panel. Osteoporosis: prevention, diagnosis, and treatment. Iberoamerican consensus on osteoporosis, Iberoamerican Society of Osteology and Mineral Metabolism (SIBOMM) 2009.
   Google Scholar
• Al-Saleh Y, Sulimani R, Sabico S, et al. 2015 Guidelines for osteoporosis in Saudi Arabia: recommendations from the Saudi Osteoporosis Society. Ann Saudi Med. 2015;35:1–12.
   PubMed Web of Science ®Google Scholar
• Lau EMC, Lee JK, Suriwongpaisal P, et al. The incidence of hip fracture in four Asian countries: the Asian Osteoporosis Study (AOS). Osteoporos Int. 2001;12:239–243.
   Google Scholar
• Lau EMC, Sambrook P, Seeman E, et al. Guidelines for diagnosing, prevention and treatment of osteoporosis in Asia. APLAR J Rheumatol. 2006;9:24–36.
   Google Scholar
• Maalouf G, Gannagé-Yared MH, Ezzedine J, et al. Middle East and North Africa consensus on osteoporosis. J Musculoskelet Neuronal Interact. 2007;7:131–143.
   PubMedGoogle Scholar
• Langdahl BL, Ljunggren O, Benhamou CL, et al. Fracture rate, quality of life and back pain in patients with osteoporosis treated with teriparatide: 24-month results from the Extended Forsteo Observational Study (ExFOS). Calcif Tissue Int. 2016;99:259–271.
   PubMed Web of Science ®Google Scholar
• Ljunggren O, Benhamou CL, Dekker J, et al. Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS). Curr Med Res Opin. 2014;30:1607–1616.
   PubMed Web of Science ®Google Scholar
• Rajzbaum G, Jakob F, Karras D, et al. Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting. Curr Med Res Opin. 2008;24:377–384.
   PubMed Web of Science ®Google Scholar