Randomized, Double-Blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observation Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Number of Patients Who Had Therapeutic Response at 6 Months
研究概览
简要总结
The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 years or older
- •SAP 2 times ULN
- •Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.).
- •90 days washout calcitonin
- •180 day washout bisphosphonate
排除标准
- •Allergic reaction to bisphosphonates
- •History of upper GI disorders
- •History of iritis, uveitis
- •Calculated creatinine clearance < 30 ml/min at baseline
- •Evidence of vitamin D deficiency
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Zoledronic acid and placebo to risedronate
Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
干预措施: zoledronic acid (Drug)
Zoledronic acid and placebo to risedronate
Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
干预措施: Placebo to risedronate (Drug)
Zoledronic acid and placebo to risedronate
Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
干预措施: Calcium and vitamin D supplements (Drug)
Risedronate and placebo to zoledronic acid
Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
干预措施: placebo to zoledronic acid (Drug)
Risedronate and placebo to zoledronic acid
Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
干预措施: Risedronate (Drug)
Risedronate and placebo to zoledronic acid
Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
干预措施: Calcium and vitamin D supplements (Drug)
结局指标
主要结局
Number of Patients Who Had Therapeutic Response at 6 Months
时间窗: Baseline, 6 months
A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.
次要结局
- Relative Change in Serum Alkaline Phosphatase in U/L at Day 28(Baseline and 28 days)
- Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10(Baseline and day 10)
- Relative Change in Urine α-CTx in ug/mmol at Day 10(Baseline and day 10)
- Time to First Therapeutic Response(182 days)
- Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28(Day 28)
- Change in Pain Severity at Day 182(Baseline and day 182)
- Change in Pain Interference at Day 182(Baseline and day 182)
- Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period(8 years was the maximum)
- Number of Participants With a Partial Disease Relapse During the Extended Observation Period(8 years was the maximum)
- Number of Participants With a Disease Relapse During the Extended Observation Period(8 years was maximum)