Three-year denosumab treatment in postmenopausal Japanese women and men with osteoporosis: results from a 1-year open-label extension of the Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT)
| Autor: | Toshitsugu Sugimoto, Masao Fukunaga, Hideo Takami, Takami Miki, Teruki Sone, Sakae Tanaka, Toshiyuki Yoneda, Ko Watanabe, Naoki Okubo, Takashi Nakamura, Masako Ito, Hideki Yoshikawa, Yoshiya Tanaka, Itsuo Gorai, Masataka Shiraki, T. Nakano, Shigeyuki Matsui, Takayuki Hosoi, Toshio Matsumoto, Taisuke Osakabe |
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| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty Endocrinology Diabetes and Metabolism Injections Subcutaneous Osteoporosis Placebo-controlled study Placebo Drug Administration Schedule law.invention Bone remodeling Randomized controlled trial Double-Blind Method law Bone Density Internal medicine Medicine Humans Vitamin D Adverse effect Osteoporosis Postmenopausal Aged Bone Density Conservation Agents business.industry Middle Aged medicine.disease Denosumab Physical therapy Spinal Fractures Calcium Drug Therapy Combination Female Bone Remodeling business Osteonecrosis of the jaw Biomarkers Osteoporotic Fractures medicine.drug |
| Zdroj: | Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 26(2) |
| ISSN: | 1433-2965 |
| Popis: | A 12-month extension phase of DIRECT in Japanese subjects with osteoporosis showed that total 3 years of denosumab treatment in Japanese postmenopausal women and men with osteoporosis was associated with low fracture rates, persistent bone turnover marker (BTM) reductions, continuous bone mineral density (BMD) increases, and a favorable overall benefit/risk profile. The DIRECT trial demonstrated that 2 years of treatment with denosumab 60 mg subcutaneously every 6 months significantly reduced the incidence of vertebral fracture compared to placebo in Japanese postmenopausal women and men with osteoporosis. The purpose of this study is to evaluate the efficacy and safety of denosumab treatment for up to 3 years. This study includes a 2-year randomized, double-blind, placebo-controlled phase and a 1-year open-label extension phase in which all subjects received denosumab. The data correspond to 3 years of denosumab treatment in subjects who received denosumab (long-term group) and 1 year of denosumab treatment in subjects who received placebo (cross-over group) in the double-blind phase. Eight hundred and ten subjects who completed the double-blind phase enrolled into the extension phase, and 775 subjects completed the study. All subjects received denosumab with daily supplements of calcium and vitamin D. The cumulative 36-month incidences of new or worsening vertebral fractures and new vertebral fractures were 3.8 and 2.5 %, respectively, in the long-term group. In this group, the BMD continued to increase, and the reduction in BTMs was maintained. In the cross-over group, comparable BMD increases and BTMs reductions to those of in their first year of the long-term group were confirmed. Adverse events did not show a notable increase with long-term denosumab administration. One event of osteonecrosis of the jaw occurred in the cross-over group. Three-year denosumab treatment in Japanese subjects with osteoporosis showed a favorable benefit/risk profile. |
| Databáze: | OpenAIRE |
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