A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
2014年4月17日 更新者：GlaxoSmithKline
A Six Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study With a Six Month Open-Label Extension to Evaluate the Efficacy and Safety of Denosumab in Korean Postmenopausal Women With Osteoporosis
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.
研究概览
研究类型
介入性
注册 (实际的)
135
阶段
- 第三阶段
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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Busan、大韩民国、602-739
- GSK Investigational Site
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Daegu、大韩民国
- GSK Investigational Site
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Gwangju、大韩民国、501-757
- GSK Investigational Site
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Seoul、大韩民国、120-752
- GSK Investigational Site
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Seoul、大韩民国、137-701
- GSK Investigational Site
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Seoul、大韩民国、110-744
- GSK Investigational Site
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Seoul、大韩民国、135-710
- GSK Investigational Site
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Seoul、大韩民国、100-380
- GSK Investigational Site
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Suwon、大韩民国、443-721
- GSK Investigational Site
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songpa-gu, Seoul、大韩民国、138-736
- GSK Investigational Site
-
-
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
60年 至 90年 (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:
- Ambulatory Korean postmenopausal women with osteoporosis
- greater than 5 years postmenopausal
- aged 60 to 90 years old
- absolute bone mineral density value consistent with a T-score less than -2.5 and greater than or equal to - 4.0 at the either the lumbar spine or total hip, as measured by dual energy x-ray absorptiometry. Subjects with a T-score less than -4.0 are at very high risk for fracture and will be excluded.
Exclusion Criteria:
- previous or current metabolic bone disease, Paget's or Cushing's disease, or hyperprolactinemia
- current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable thyroid replacement therapy and TSH level meets criteria
- rheumatoid arthritis
- cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal
- medications used to treat osteoporosis, defined for type and duration of use, and including IV and oral bisphosphonates
- medications that affect bone metabolism including parathyroid hormone or derivatives; anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol or vitamin D derivatives; other bone active drugs including anticonvulsives (but not benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and gonadotropin-releasing hormone agonists
- malignancy within 5 years except certain resected types
- malabsorption syndrome or gastrointestinal disorders associated with malabsorption
- abnormal calcium level
- vitamin D deficiency
- any laboratory abnormality that will prevent the subject from completing the study or interfere with interpretation of study results
- severe renal impairment or on dialysis
- impaired immune system or subject is taking immunosuppressants
- oral or dental conditions including current or past history of osteomyelitis or osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery; planned invasive dental procedure; un-healed dental or oral surgery
- any disorder that compromises the ability of the subject to give written informed consent or to comply with study procedures
- any physical or psychiatric disorder that will prevent the subject from completing the study or interferes with study results
- known to have tested positive for HIV
- less than two lumbar vertebrae evaluable for DXA measurements
- height, weight, or girth that may preclude accurate DXA measurements
- drug or alcohol abuse within 12 months that interferes with understanding or completing the study
- known sensitivity to mammalian cell-derived drug products
- use of an investigational drug or device within 30 days of enrollment or currently receiving other investigational agent(s)
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：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Arm 1
denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase
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double-blind phase: 60mg subcutaneous injection, single dose
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安慰剂比较：Arm 2
placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase
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double-blind phase: placebo subcutaneous injection, single dose
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实验性的：Arm 3
open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase
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open-label phase: 60mg subcutaneous injection, single dose
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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 |
|---|---|---|
|
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
大体时间：Baseline and Month 6
|
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner.
Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate.
Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline * 100.
|
Baseline and Month 6
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
大体时间：Baseline and Month 1
|
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner.
Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate.
Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline * 100.
|
Baseline and Month 1
|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
大体时间：Baseline, Month 1 and Month 6
|
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner.
Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate.
Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline * 100.
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Baseline, Month 1 and Month 6
|
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Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
大体时间：Baseline, Months 1, 3 and 6
|
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L).
Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline * 100.
|
Baseline, Months 1, 3 and 6
|
|
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)
大体时间：From Baseline up to Month 6
|
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.
Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
|
From Baseline up to Month 6
|
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Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
|
Change From Baseline in Hematocrit at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
|
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
|
Change From Baseline in Mean Corpuscular Volume at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
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Change From Baseline in Red Blood Cell Count at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
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Change From Baseline in Red Cell Distribution Width at Month 6
大体时间：Baseline and Month 6
|
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
|
Baseline and Month 6
|
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Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
大体时间：Baseline and Month 6
|
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized.
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
大体时间：Month 6
|
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.
|
Month 6
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab
大体时间：Baseline and Month 12
|
Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner.
Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate.
Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline * 100.
|
Baseline and Month 12
|
|
Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo
大体时间：Month 6 and Month 12
|
Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner.
Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate.
Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 * 100.
|
Month 6 and Month 12
|
|
Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab
大体时间：Baseline and Month 12
|
Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner.
Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate.
Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline * 100.
|
Baseline and Month 12
|
|
Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo
大体时间：Month 6 and Month 12
|
Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner.
Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate.
Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 * 100.
|
Month 6 and Month 12
|
|
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab
大体时间：Baseline and Month 12
|
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L).
Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline * 100.
|
Baseline and Month 12
|
|
Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo
大体时间：Month 6 and Month 12
|
Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L).
Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by measure at Month 6 * 100.
|
Month 6 and Month 12
|
|
Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase
大体时间：From Month 6 to Month 12
|
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.
Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
|
From Month 6 to Month 12
|
|
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Change From Baseline in Hematocrit at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Change From Baseline in Mean Corpuscle Hemoglobin at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Change From Baseline in Red Blood Cell Count at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Change From Baseline in Red Cell Distribution Width at Month 12
大体时间：Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
大体时间：Baseline and Month 12
|
Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized.
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
|
|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12
大体时间：Month 12
|
Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.
|
Month 12
|
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
2011年11月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2013年6月1日
研究注册日期
首次提交
2011年10月20日
首先提交符合 QC 标准的
2011年10月20日
首次发布 (估计)
2011年10月24日
研究记录更新
最后更新发布 (估计)
2014年5月7日
上次提交的符合 QC 标准的更新
2014年4月17日
最后验证
2014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.