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)
| Autor: | Ryoichi Takayanagi, Saeko Fujiwara, Satoshi Soen, Mika Tsujimoto, Hiroyuki Enomoto, John H. Krege, Kenta Kajimoto, Masayo Sato, Shuichi Kimura |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty Osteoporosis Treatment interval 030209 endocrinology & metabolism 03 medical and health sciences 0302 clinical medicine Lumbar Japan Bone Density Teriparatide Internal medicine Activities of Daily Living medicine Back pain Humans Prospective Studies Aged Pain Measurement Aged 80 and over Bone mineral Lumbar Vertebrae Bone Density Conservation Agents business.industry General Medicine Odds ratio Middle Aged medicine.disease Surgery Back Pain Female Observational study 030101 anatomy & morphology medicine.symptom business Osteoporotic Fractures medicine.drug |
| Zdroj: | Current Medical Research and Opinion. 33:2049-2056 |
| ISSN: | 1473-4877 0300-7995 |
| DOI: | 10.1080/03007995.2017.1354826 |
| Popis: | 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.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.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.JFOS demonstrated effectiveness of teriparatide 20 μg/day to reduce the risk of clinical fractures in Japanese patients in a real-world setting. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|