Chung-Hwan Chen1, Abdulaziz H Elsalmawy2, Sophia Ish-Shalom3, Seung-Jae Lim4, Nadia S Al-Ali5, Joao L Cunha-Borges6, Huilin Yang7, Noemí Casas8, Lale Altan9, Thomas Moll10, Sirel Gurbuz11, Alan J M Brnabic11, Russel T Burge11,12, Fernando Marin10. 1. a Department of Orthopedics , College of Medicine and Kaohsiung Medical University Hospital, Kaohsiung Medical University , Kaohsiung City , Taiwan. 2. b Department of Trauma and Orthopedic Surgery , Al Noor Specialized Hospital Makkah , Mecca , Saudi Arabia. 3. c Lin Endocrine Research Center , Haifa , Israel. 4. d Department of Orthopedic Surgery , Sungkyunkwan University School of Medicine , Seoul , South Korea. 5. e Endocrinology Unit , Amiri Hospital, MOH , Kuwait. 6. f Faculty of Medicine , Universidade Católica de Brasília , Brasilia , Brazil. 7. g Department of Orthopedics , The First Affiliated Hospital of Soochow University , Suzhou , China. 8. h Riesgo de Fractura CAYRE , Bogotá , Colombia. 9. i Department of Physical Medicine and Rehabilitation , Uludağ University School of Medicine , Bursa , Turkey. 10. j Lilly Research Center , Windlesham , United Kingdom. 11. k Lilly Research Laboratories , Indianapolis , IN , USA. 12. l Winkle College of Pharmacy , University of Cincinnati , Cincinnati , OH , USA.
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.
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 ALAFOSparticipant 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.
Authors: O Gómez; A P Talero; M B Zanchetta; M Madeira; C A Moreira; C Campusano; A M Orjuela; S Cerdas P; M P de la Peña-Rodríguez; A A Reza; C Velazco; B Mendoza; L R Uzcátegui; P N Rueda Journal: Arch Osteoporos Date: 2021-07-24 Impact factor: 2.617
Authors: Abdul Aziz Elsalmawy; Nadia S Al-Ali; Yasser Yaghi; Hussein Assaggaf; Ghassan Maalouf; Mir Sadat-Ali; Essam Zaher; Said Saghieh; Ahmed Mahmoud; Mohamed Taher Journal: J Int Med Res Date: 2020-08 Impact factor: 1.671