Satoshi Soen1, Saeko Fujiwara2, Ryoichi Takayanagi3,4, Kenta Kajimoto5, Mika Tsujimoto5, Shuichi Kimura5, Masayo Sato5, John H Krege6, Hiroyuki Enomoto5. 1. a Department of Orthopaedic Surgery and Rheumatology , Kindai University, Nara Hospital , Ikoma city , Japan. 2. b Health Management and Promotion Center, Hiroshima Atomic Bomb Casualty Council , Hiroshima city , Japan. 3. c Center for Preventive Medicine, Fukuoka Sanno Hospital , Fukuoka , Japan. 4. d International University of Health and Welfare , Fukuoka , Japan. 5. e Medicines Development Unit Japan, Eli Lilly Japan K.K. , Kobe , Japan. 6. f Bio-Medicines Core Team, Eli Lilly and Company , Indianapolis , IN , USA.
Abstract
OBJECTIVE: The Japan Fracture Observational Study (JFOS), a prospective observational study, investigated the real-world effectiveness of daily teriparatide to reduce clinical fracture risk in osteoporotic patients. METHODS: In routine clinical practice, Japanese patients initiated on teriparatide 20 μg/day by subcutaneous injection were enrolled. The primary end-point was the rate of clinical fractures at 6-month intervals over 24 months. Bone mineral density (BMD), procollagen type 1 aminoterminal propeptide (P1NP), back pain, and health-related quality-of-life (HRQoL) information was collected. RESULTS: Of 1,996 patients at baseline, 90.1% were female, and mean age was 76.9 years. Teriparatide persistence at 12 and 24 months was 68.0% and 51.6%, respectively. Compared to the first 6-month treatment interval, the odds ratio of fractures decreased by 56.4% during 6-12 months, 51.6% during 12-18 months, and 58.8% during 18-24 months (all p < .01). After 24 months, BMD increased by 17.2% (lumbar spine) and 7.9% (total hip). After 6 months, P1NP levels increased by 259.3%. A reduction in back pain (100 mm visual analog scale) of 16.1 mm at 3 months was maintained through 24 months. HRQoL (pain, daily living activities, general health) improved by ≥10% at each post-baseline time point. Of 279 (14.6%) patients with ≥1 adverse event (AE), 71 (3.7%) experienced ≥1 drug-related AE (investigator assessed), including nausea (0.7%), dizziness (0.4%), and decreased appetite (0.3%). Osteosarcoma was not reported; there were no new safety signals. CONCLUSIONS: JFOS demonstrated effectiveness of teriparatide 20 μg/day to reduce the risk of clinical fractures in Japanese patients in a real-world setting.
OBJECTIVE: The Japan Fracture Observational Study (JFOS), a prospective observational study, investigated the real-world effectiveness of daily teriparatide to reduce clinical fracture risk in osteoporoticpatients. METHODS: In routine clinical practice, Japanese patients initiated on teriparatide 20 μg/day by subcutaneous injection were enrolled. The primary end-point was the rate of clinical fractures at 6-month intervals over 24 months. Bone mineral density (BMD), procollagen type 1 aminoterminal propeptide (P1NP), back pain, and health-related quality-of-life (HRQoL) information was collected. RESULTS: Of 1,996 patients at baseline, 90.1% were female, and mean age was 76.9 years. Teriparatide persistence at 12 and 24 months was 68.0% and 51.6%, respectively. Compared to the first 6-month treatment interval, the odds ratio of fractures decreased by 56.4% during 6-12 months, 51.6% during 12-18 months, and 58.8% during 18-24 months (all p < .01). After 24 months, BMD increased by 17.2% (lumbar spine) and 7.9% (total hip). After 6 months, P1NP levels increased by 259.3%. A reduction in back pain (100 mm visual analog scale) of 16.1 mm at 3 months was maintained through 24 months. HRQoL (pain, daily living activities, general health) improved by ≥10% at each post-baseline time point. Of 279 (14.6%) patients with ≥1 adverse event (AE), 71 (3.7%) experienced ≥1 drug-related AE (investigator assessed), including nausea (0.7%), dizziness (0.4%), and decreased appetite (0.3%). Osteosarcoma was not reported; there were no new safety signals. CONCLUSIONS:JFOS demonstrated effectiveness of teriparatide 20 μg/day to reduce the risk of clinical fractures in Japanese patients in a real-world setting.
Authors: Gotzone Hervás; Fatima Ruiz-Litago; Jon Irazusta; Amaia Irazusta; Begoña Sanz; Javier Gil-Goikouria; Ana Belen Fraile-Bermudez; Carmen Pérez-Rodrigo; Idoia Zarrazquin Journal: Int J Environ Res Public Health Date: 2019-08-08 Impact factor: 3.390
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