A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
2014년 4월 17일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
135
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Busan, 대한민국, 602-739
- GSK Investigational Site
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Daegu, 대한민국
- GSK Investigational Site
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Gwangju, 대한민국, 501-757
- GSK Investigational Site
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Seoul, 대한민국, 120-752
- GSK Investigational Site
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Seoul, 대한민국, 137-701
- GSK Investigational Site
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Seoul, 대한민국, 110-744
- GSK Investigational Site
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Seoul, 대한민국, 135-710
- GSK Investigational Site
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Seoul, 대한민국, 100-380
- GSK Investigational Site
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Suwon, 대한민국, 443-721
- GSK Investigational Site
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songpa-gu, Seoul, 대한민국, 138-736
- GSK Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
60년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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위약 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
기간: Baseline and Month 6
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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.
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Baseline and Month 6
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
기간: Baseline and Month 1
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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.
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Baseline and Month 1
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Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6
기간: Baseline, Month 1 and Month 6
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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
기간: Baseline, Months 1, 3 and 6
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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.
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Baseline, Months 1, 3 and 6
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Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)
기간: From Baseline up to Month 6
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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.
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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
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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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
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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Change From Baseline in Hematocrit at Month 6
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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Change From Baseline in Mean Corpuscular Volume at Month 6
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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Change From Baseline in Red Blood Cell Count at Month 6
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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Baseline and Month 6
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Change From Baseline in Red Cell Distribution Width at Month 6
기간: Baseline and Month 6
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Change from Baseline was calculated as the Month 6 value minus the Baseline value.
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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
기간: Baseline and Month 6
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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
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Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
기간: Month 6
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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.
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Month 6
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab
기간: Baseline and Month 12
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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.
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Baseline and Month 12
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Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo
기간: 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.
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Month 6 and Month 12
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Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab
기간: 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.
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Baseline and Month 12
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Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo
기간: 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
|
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Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab
기간: 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
기간: 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.
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Month 6 and Month 12
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Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase
기간: From Month 6 to Month 12
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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.
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From Month 6 to Month 12
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Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12
기간: Baseline and Month 12
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Change from Baseline was calculated as the Month 12 value minus the Baseline value.
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Baseline and Month 12
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Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12
기간: Baseline and Month 12
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Change from Baseline was calculated as the Month 12 value minus the Baseline value.
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Baseline and Month 12
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Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
기간: Baseline and Month 12
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Change from Baseline was calculated as the Month 12 value minus the Baseline value.
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Baseline and Month 12
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Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12
기간: Baseline and Month 12
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Change from Baseline was calculated as the Month 12 value minus the Baseline value.
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Baseline and Month 12
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Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
기간: Baseline and Month 12
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Change from Baseline was calculated as the Month 12 value minus the Baseline value.
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Baseline and Month 12
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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
기간: Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
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Baseline and Month 12
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Change From Baseline in Hematocrit at Month 12
기간: Baseline and Month 12
|
Change from Baseline was calculated as the Month 12 value minus the Baseline value.
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Baseline and Month 12
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Change From Baseline in Mean Corpuscle Hemoglobin at Month 12
기간: Baseline and Month 12
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Change from Baseline was calculated as the Month 12 value minus the Baseline value.
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Baseline and Month 12
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Change From Baseline in Red Blood Cell Count at Month 12
기간: Baseline and Month 12
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Change from Baseline was calculated as the Month 12 value minus the Baseline value.
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Baseline and Month 12
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Change From Baseline in Red Cell Distribution Width at Month 12
기간: Baseline and Month 12
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Change from Baseline was calculated as the Month 12 value minus the Baseline value.
|
Baseline and Month 12
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Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12
기간: Baseline and Month 12
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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
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|
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12
기간: 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
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 11월 1일
기본 완료 (실제)
2012년 12월 1일
연구 완료 (실제)
2013년 6월 1일
연구 등록 날짜
최초 제출
2011년 10월 20일
QC 기준을 충족하는 최초 제출
2011년 10월 20일
처음 게시됨 (추정)
2011년 10월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 5월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 4월 17일
마지막으로 확인됨
2014년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .