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Abstract
The Asian and Latin America Fracture Observational Study (ALAFOS) is a prospective, observational, single-arm study conducted in 20 countries across Asia, Latin America and the Middle East. ALAFOS evaluated new clinical vertebral and non-vertebral fragility fractures in relation to time on teriparatide, in postmenopausal women with osteoporosis in real-life clinical practice. Clinical fragility fractures, back pain, and health-related quality of life (HRQoL) were recorded in 6-month intervals for ≤ 24 months during teriparatide treatment and up to 12-months post-treatment. Data were analysed with piecewise exponential regression with inverse probability weighting for time to event outcomes and mixed-model repeated measures for back pain and HRQoL. 3054 postmenopausal women started teriparatide and attended ≥ one follow-up visit (mean [SD] age 72.5 [10.4] years). The median (95% CI) time to treatment discontinuation was 22.0 months (21.2, 22.8). During the treatment period, 111 patients (3.6%) sustained 126 clinical fractures (2.98 fractures/100 patient-years). Rates of new clinical fragility fractures were significantly decreased during the > 6–12, > 12–18, and > 18–24-month periods, as compared with the first 6 months of treatment (hazard ratio [HR] 0.57; 95% CI 0.37, 0.88; p = 0.012; HR 0.35; 95% CI 0.19, 0.62; p < 0.001; HR 0.43; 95% CI 0.23, 0.83; p = 0.011; respectively). Patients also reported an improvement in back pain and HRQoL (p < 0.001). These results provide data on the real-world effectiveness of teriparatide in the ALAFOS regions and are consistent with other studies showing reduction of fractures after 6 months of teriparatide treatment. These results should be interpreted in the context of the noncontrolled design of this observational study.
Highlights
Osteoporotic fractures lead to acute pain, increased morbidity and mortality and a lower quality of life as well as higher health care costs [1]
The study was conducted in the following countries: Argentina, Australia, Brazil, China, Colombia, Hong Kong, Israel, Kuwait, Lebanon, Malaysia, Mexico, New Zealand, Russian Federation, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, Turkey and United Arab Emirates
The results presented here indicate that postmenopausal women with osteoporosis who were at a high risk of fracture and were prescribed teriparatide, as part of standard clinical practice, had a significant reduction in the rate of fragility fractures after the first 6 months of treatment
Summary
Osteoporotic fractures lead to acute pain, increased morbidity and mortality and a lower quality of life as well as higher health care costs [1]. It is estimated that by 2040, the number of patients with a high risk of osteoporotic fracture will reach over 300 million worldwide, presenting a significant disease burden to society [2]. In 2000, there was an estimated nine million new osteoporotic fractures worldwide [3], and as the number of people 65 years and older increases, the number of hip fractures alone is expected to reach 6.26 million globally by 2050 [4]. While the frequency of osteoporotic fractures (including hip, vertebral, and non-vertebral) varies widely globally, osteoporosis presents a growing burden in Asia, Latin America, and the Middle East [5,6,7]. Asia, Latin America, and the Middle East together will account for almost 70% of global hip fractures in women aged 65 and over [4]. The prevalence of vertebral fractures varies widely, with the rates of vertebral fractures in women aged over 50 years, ranging from 11 to 19%, in Latin American countries, 5% to 30% in Asian countries, and 20% to 46% in Middle Eastern countries [8]
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