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 Observational Period
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 3
- 主要终点
- Number of Patients Who Achieve Therapeutic Response at 6 Months.
研究概览
简要总结
The core study looked at the effect of Zoledronic Acid given once as an intravenous (i.v.) infusion compared to 60 days of oral Risedronate in patients with Paget's disease of bone. The effect was demonstrated in the reduction of serum alkaline phosphatase (SAP). 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
- •Serum alkaline phosphatase (SAP) 2 times upper limit normal (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 gastrointestinal disorders
- •History of iritis, uveitis
- •Calculated creatinine clearance < 30 ml/min at baseline
- •Evidence of vitamin D deficiency
- •Other protocol-defined inclusion/exclusion criteria applied.
研究组 & 干预措施
Zoledronic Acid and Placebo to Risedronate
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 (Dietary Supplement)
Risedronate and Placebo to Zoledronic Acid
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 (Dietary Supplement)
结局指标
主要结局
Number of Patients Who Achieve Therapeutic Response at 6 Months.
时间窗: 6 months
Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.
次要结局
- Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28(Baseline and day 28)
- Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10(Baseline and day 10)
- Relative Change in Urine Alpha C-telopeptide (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 Relative to Baseline(Baseline and day 28)
- Change in Pain Severity Score(Baseline and day 182)
- Change in Pain Interference Score(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 the maximum)