Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,609
- 主要终点
- Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
研究概览
简要总结
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
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
- Double
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 55-80 years of age;
- •post-menopausal for >= 5 years;
- •ambulatory.
排除标准
- •malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
- •breast cancer within the previous 20 years;
- •allergy to bisphosphonates;
- •previous treatment with an intravenous bisphosphonate at any time;
- •previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.
研究组 & 干预措施
Ibandronate 100 mg
Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
干预措施: Calcium (Dietary Supplement)
Ibandronate 2.5 mg
Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day .
干预措施: Ibandronate [Bonviva/Boniva] (Drug)
Ibandronate 2.5 mg
Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day .
干预措施: Calcium (Dietary Supplement)
Ibandronate 2.5 mg
Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day .
干预措施: Vitamin D (Dietary Supplement)
Ibandronate 50/50 mg
Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day.
干预措施: Ibandronate [Bonviva/Boniva] (Drug)
Ibandronate 50/50 mg
Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day.
干预措施: Calcium (Dietary Supplement)
Ibandronate 50/50 mg
Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day.
干预措施: Vitamin D (Dietary Supplement)
Ibandronate 100 mg
Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
干预措施: Ibandronate [Bonviva/Boniva] (Drug)
Ibandronate 100 mg
Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
干预措施: Vitamin D (Dietary Supplement)
Ibandronate 150 mg
Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
干预措施: Ibandronate [Bonviva/Boniva] (Drug)
Ibandronate 150 mg
Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
干预措施: Calcium (Dietary Supplement)
Ibandronate 150 mg
Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
时间窗: From Baseline (Month 0) to Month 12
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
次要结局
- Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD(From Baseline (Month 0) to Month 24)
- Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24(Months 12 and 24)
- Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24(Months 12 and 24)
- Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24(Months 12 and 24)
- Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD(From Baseline (Month 0) to Months 12 and 24)
- Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD(From Baseline (Month 0) to Months 12 and 24)
- Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.(From Baseline (Month 0) to Months 12 and 24)
- Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24(Months 12 and 24)
- Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24(From Baseline (Month 0) to Months 3, 6, 12, 24)
- Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24(Months 12 and 24)
- Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24(Months 12 and 24)
- Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24(Months 12 and 24)
- Absolute Change In Baseline in Serum CTX to Months 12 and 24(From Baseline (Month 0) to Months 12 and 24)
- Number of Participants With Any Adverse Events and Serious Adverse Event(Up to Month 24)
- Number Of Participants With Marked Laboratory Abnormalities(Up to Month 24)