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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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

135

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • 大韓民国
      • Busan、大韓民国、602-739
        • GSK Investigational Site
      • Daegu、大韓民国
        • GSK Investigational Site
      • Gwangju、大韓民国、501-757
        • GSK Investigational Site
      • Seoul、大韓民国、120-752
        • GSK Investigational Site
      • Seoul、大韓民国、137-701
        • GSK Investigational Site
      • Seoul、大韓民国、110-744
        • GSK Investigational Site
      • Seoul、大韓民国、135-710
        • GSK Investigational Site
      • Seoul、大韓民国、100-380
        • GSK Investigational Site
      • Suwon、大韓民国、443-721
        • GSK Investigational Site
      • songpa-gu, Seoul、大韓民国、138-736
        • GSK Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

60年～90年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Arm 1
denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase
薬：denosumab
double-blind phase: 60mg subcutaneous injection, single dose
プラセボコンパレーター：Arm 2
placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase
薬：placebo
double-blind phase: placebo subcutaneous injection, single dose
実験的：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
薬：open-label denosumab
open-label phase: 60mg subcutaneous injection, single dose

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
時間枠：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
時間枠：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.
Baseline, Month 1 and Month 6
Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6
時間枠：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)
時間枠：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
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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 Red Blood Cell Count at Month 6
時間枠：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 Red Cell Distribution Width at Month 6
時間枠：Baseline and Month 6
Change from Baseline was calculated as the Month 6 value minus the Baseline value.
Baseline and Month 6
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6
時間枠：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.
Baseline and Month 6
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2011年11月1日

一次修了 (実際)

2012年12月1日

研究の完了 (実際)

2013年6月1日

試験登録日

最初に提出

2011年10月20日

QC基準を満たした最初の提出物

2011年10月20日

最初の投稿 (見積もり)

2011年10月24日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年5月7日

QC基準を満たした最後の更新が送信されました

2014年4月17日

最終確認日

2014年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 114163

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