Abstract：
BACKGROUND: We conducted an all-case postmarketing surveillance study between 2008 and 2017 to evaluate the safety and effectiveness of risedronate for Paget\'s disease of bone (PDB) in Japan.
METHODS: This study registered all patients who received once-daily risedronate 17.5 mg for the treatment of PDB and collected data over a 48-week follow-up period per treatment cycle for each patient.
RESULTS: The safety analysis set included 184 patients (mean age, 63.7 years), 81 (44.0%) of whom previously received a bisphosphonate. Of them, 41 (22.3%) experienced 72 adverse drug reactions (ADRs), and 8 (4.3%) experienced 14 serious ADRs. Common ADRs included gastrointestinal disorders (20 patients, 10.9%) and hypocalcemia (6 patients, 3.3%). The effectiveness analysis set included 182 patients, 124 of whom completed only one treatment cycle and 58 of whom completed multiple treatment cycles. The proportions of patients who normalized serum alkaline phosphatase (ALP) concentration were 71.1% (113/159 patients) and 67.3% (33/49 patients) for the first and second treatment cycles, respectively. The relapse rate according to ALP levels after the end of treatment for the first cycle was 5.0% (95% confidence interval [CI] = 2.1-11.5) at 24 weeks and 12.9% (95% CI = 7.5-21.7) at 40 weeks. Regarding pain relief, the achievement rates were 70.0% (49/70 patients) and 30.8% (4/13 patients) for the first and second treatment cycles, respectively.
CONCLUSIONS: To conclude, risedronate 17.5 mg/day is safe and effective for treating patients with PDB in daily practice.
METHODS: This study registered all patients who received once-daily risedronate 17.5 mg for the treatment of PDB and collected data over a 48-week follow-up period per treatment cycle for each patient.
RESULTS: The safety analysis set included 184 patients (mean age, 63.7 years), 81 (44.0%) of whom previously received a bisphosphonate. Of them, 41 (22.3%) experienced 72 adverse drug reactions (ADRs), and 8 (4.3%) experienced 14 serious ADRs. Common ADRs included gastrointestinal disorders (20 patients, 10.9%) and hypocalcemia (6 patients, 3.3%). The effectiveness analysis set included 182 patients, 124 of whom completed only one treatment cycle and 58 of whom completed multiple treatment cycles. The proportions of patients who normalized serum alkaline phosphatase (ALP) concentration were 71.1% (113/159 patients) and 67.3% (33/49 patients) for the first and second treatment cycles, respectively. The relapse rate according to ALP levels after the end of treatment for the first cycle was 5.0% (95% confidence interval [CI] = 2.1-11.5) at 24 weeks and 12.9% (95% CI = 7.5-21.7) at 40 weeks. Regarding pain relief, the achievement rates were 70.0% (49/70 patients) and 30.8% (4/13 patients) for the first and second treatment cycles, respectively.
CONCLUSIONS: To conclude, risedronate 17.5 mg/day is safe and effective for treating patients with PDB in daily practice.
摘要：
背景：我们在2008年至2017年之间进行了一项全病例上市后监测研究，以评估利塞膦酸盐治疗日本Paget骨病（PDB）的安全性和有效性。
方法：本研究登记了所有接受每日一次利塞膦酸盐17.5mg治疗PDB的患者，并收集了每个患者每个治疗周期48周随访期间的数据。
结果：安全性分析集包括184名患者（平均年龄，63.7年)，81人（44.0%）以前接受过双膦酸盐。其中,41例（22.3%）发生72例药物不良反应（ADR），8例（4.3%）出现14例严重不良反应。常见的不良反应包括胃肠道疾病(20例患者，10.9％）和低钙血症（6例，3.3%）。有效性分析集包括182名患者，其中124人只完成了一个治疗周期，58人完成了多个治疗周期。第一和第二治疗周期血清碱性磷酸酶（ALP）浓度恢复正常的患者比例为71.1％（113/159例）和67.3％（33/49例）。分别。根据ALP水平，第一个周期治疗结束后的复发率在24周时为5.0％（95％置信区间[CI]=2.1-11.5），在40周时为12.9％（95％CI=7.5-21.7）。关于疼痛缓解，第一和第二治疗周期的成功率分别为70.0%(49/70例)和30.8%(4/13例),分别。
结论：总而言之，利塞膦酸钠17.5mg/d在日常实践中对PDB患者的治疗是安全有效的。
方法：本研究登记了所有接受每日一次利塞膦酸盐17.5mg治疗PDB的患者，并收集了每个患者每个治疗周期48周随访期间的数据。
结果：安全性分析集包括184名患者（平均年龄，63.7年)，81人（44.0%）以前接受过双膦酸盐。其中,41例（22.3%）发生72例药物不良反应（ADR），8例（4.3%）出现14例严重不良反应。常见的不良反应包括胃肠道疾病(20例患者，10.9％）和低钙血症（6例，3.3%）。有效性分析集包括182名患者，其中124人只完成了一个治疗周期，58人完成了多个治疗周期。第一和第二治疗周期血清碱性磷酸酶（ALP）浓度恢复正常的患者比例为71.1％（113/159例）和67.3％（33/49例）。分别。根据ALP水平，第一个周期治疗结束后的复发率在24周时为5.0％（95％置信区间[CI]=2.1-11.5），在40周时为12.9％（95％CI=7.5-21.7）。关于疼痛缓解，第一和第二治疗周期的成功率分别为70.0%(49/70例)和30.8%(4/13例),分别。
结论：总而言之，利塞膦酸钠17.5mg/d在日常实践中对PDB患者的治疗是安全有效的。
