The Effect of Teriparatide Treatment on the Risk of Fragility Fractures in Postmenopausal Women with Osteoporosis: Results from the Asian and Latin America Fracture Observational Study (ALAFOS)

• Published in: Calcified tissue international Vol. 110; no. 1; pp. 74 - 86
• Main Authors: Chen, Chung-Hwan, Elsalmawy, Abdulaziz H., Ish-Shalom, Sophia, Lim, Seung-Jae, AlAli, Nadia S., Cunha-Borges, Joao L., Yang, Huilin, Casas, Noemi, Altan, Lale, Belaya, Zhanna, Marin, Fernando, Moll, Thomas, Gurbuz, Sirel, Brnabic, Alan, Pavo, Imre, Florez, Sandra
• Format: Journal Article
• Language: English
• Published: New York Springer US 01-01-2022; Springer Nature B.V
• Subjects: Aged; Back pain; Biochemistry; Biomedical and Life Sciences; Bone Density Conservation Agents - therapeutic use; Cell Biology; Endocrinology; Female; Fractures; Humans; Latin America; Life Sciences; Observational studies; Original Research; Orthopedics; Osteoporosis; Osteoporosis, Postmenopausal - complications; Osteoporosis, Postmenopausal - drug therapy; Osteoporotic Fractures - epidemiology; Osteoporotic Fractures - prevention & control; Pain; Parathyroid hormone; Patients; Post-menopause; Postmenopause; Prospective Studies; Quality of Life; Spinal Fractures - epidemiology; Spinal Fractures - prevention & control; Teriparatide - therapeutic use; Vertebrae; Latin America; Osteoporosis; Observational study; Back pain; Fracture; Teriparatide
• ISSN: 0171-967X; 1432-0827
• DOI: 10.1007/s00223-021-00895-4

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.