A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
2016年2月10日 更新者：Hoffmann-La Roche
A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients
This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment.
The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.
研究概览
研究类型
介入性
注册 (实际的)
308
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Ponce、波多黎各、00717-1318
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San Juan、波多黎各、00935
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San Juan、波多黎各、00927
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Alabama
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Montgomery、Alabama、美国、36111
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Arizona
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Chandler、Arizona、美国、85225
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Peoria、Arizona、美国、85381
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Arkansas
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Hot Springs、Arkansas、美国、71913
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Pine Bluff、Arkansas、美国、71603
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California
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Anaheim、California、美国、92801
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Beverly Hills、California、美国、90211
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Carmichael、California、美国、95608
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Delaware
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Wilmington、Delaware、美国、19805
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Florida
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Deland、Florida、美国、32720
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Miami、Florida、美国、33186
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Miami、Florida、美国、33176
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Palm Habor、Florida、美国、34684
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Palm Springs、Florida、美国、33461
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West Palm Beach、Florida、美国、33409
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Georgia
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Atlanta、Georgia、美国、30309
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Rome、Georgia、美国、30165
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Illinois
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Morton Grove、Illinois、美国、60053
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Indiana
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Indianapolis、Indiana、美国、46202
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Iowa
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Waterloo、Iowa、美国、50702
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Maryland
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Baltimore、Maryland、美国、21209
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Hagerstown、Maryland、美国、21740
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Reistertown、Maryland、美国、21136
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Mississippi
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Olive Branch、Mississippi、美国、38654
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Missouri
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Jefferson City、Missouri、美国、65109
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St Louis、Missouri、美国、63108
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Nebraska
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Omaha、Nebraska、美国、68131
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New Jersey
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Bloomfield、New Jersey、美国、07003
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New York
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Bronx、New York、美国、10461
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New York、New York、美国、10016
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North Carolina
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Morehead City、North Carolina、美国、28557
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Morganton、North Carolina、美国、28655
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Raleigh、North Carolina、美国、27612
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Oklahoma
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Oklahoma City、Oklahoma、美国、73112
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Oregon
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Medford、Oregon、美国、97504
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Pennsylvania
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Doylestown、Pennsylvania、美国、18901
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Langhorne、Pennsylvania、美国、19047
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Philadelphia、Pennsylvania、美国、19131
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South Carolina
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Mount Pleasant、South Carolina、美国、29464
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Spartanburg、South Carolina、美国、29307
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Tennessee
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Morristown、Tennessee、美国、37813
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Murfreesboro、Tennessee、美国、37130
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Nashville、Tennessee、美国、37203
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Texas
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Amarillo、Texas、美国、79106
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Fort Worth、Texas、美国、76101
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San Antonio、Texas、美国、78229
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Texarkana、Texas、美国、75503
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Virginia
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Richmond、Virginia、美国、23226
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Washington
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Tacoma、Washington、美国、98405
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Wisconsin
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Madison、Wisconsin、美国、53705
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Women newly diagnosed with postmenopausal osteoporosis
- Naive to prior bisphosphonate therapy
Exclusion Criteria:
- Inability to stand or sit upright for at least 60 minutes
- Inability to swallow a tablet whole
- Hypersensitivity to any component of ibandronate
- Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
- Other osteoporosis drug within last 3 months
- Malignant disease diagnosed within previous 10 years, except resected basal cell cancer
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Ibandronate Group 1
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly.
Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results.
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Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
其他名称：
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实验性的：Ibandronate Group 2
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly.
Group 2 will not receive a physician consultation.
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Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
大体时间：Baseline, Month 6
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Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL).
Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)
大体时间：Baseline, Month 6
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Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine.
Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
大体时间：Baseline, Month 6
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Serum P1NP is a measure of bone resorption and is measured as ng/mL.
Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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Percent Change From Baseline to Month 6 in Serum Osteocalcin
大体时间：Baseline, Month 6
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Serum osteocalcin is a measure of bone resorption and is measured as ng/mL.
Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)
大体时间：Baseline, Month 6
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Serum BSAP is a measure of bone resorption and is measured as ng/mL.
Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100.
Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
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Baseline, Month 6
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Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
大体时间：Month 6
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The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture.
Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.'
A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS.
(1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.
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Month 6
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年8月1日
初级完成 (实际的)
2006年5月1日
研究完成 (实际的)
2006年5月1日
研究注册日期
首次提交
2015年11月4日
首先提交符合 QC 标准的
2015年11月4日
首次发布 (估计)
2015年11月6日
研究记录更新
最后更新发布 (估计)
2016年3月9日
上次提交的符合 QC 标准的更新
2016年2月10日
最后验证
2016年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.