A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
2014年1月9日 更新者：GlaxoSmithKline
A Six-Month Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Denosumab in Indian 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 Indian postmenopausal women with osteoporosis.
調査の概要
研究の種類
介入
入学 (実際)
250
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
-
-
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Ahmedabad、インド、380015
- GSK Investigational Site
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Bangalore、インド、560043
- GSK Investigational Site
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Bangalore、インド、560052
- GSK Investigational Site
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Bangalore、インド、560054
- GSK Investigational Site
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Delhi、インド、110060
- GSK Investigational Site
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Mangalore、インド、575002
- GSK Investigational Site
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Nagpur、インド、440010
- GSK Investigational Site
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Nagpur、インド、440012
- GSK Investigational Site
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Pune、インド、411030
- GSK Investigational Site
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Trivandrum、インド、695011
- GSK Investigational Site
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Vadodra、インド、390007
- GSK Investigational Site
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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
55年～75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 Indian postmenopausal women with osteoporosis
- greater than 5 years postmenopausal
- aged 55 to 75 years old
- absolute bone mineral density value consistent with a T-score less than -2.5 and greater than - 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 or equal to -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 interferes with interpretation of study results
- 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 |
|---|---|
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実験的：Arm 1
denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind treatment
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60mg subcutaneous injection, single dose
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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 treatment
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placebo subcutaneous injection, single dose
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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 |
|---|---|---|
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Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6
時間枠：Baseline and Month 6
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Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner.
The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value.
Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).
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Baseline and Month 6
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6
時間枠：Baseline and Month 6
|
BMD at the total hip, femoral neck, and trochanter was measured by the DXA scanner.
The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value.
Analysis was performed using an ANCOVA model with terms for treatment and corresponding Baseline BMD (as a continuous covariate).
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Baseline and Month 6
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Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6
時間枠：Baseline; Months 1, 3, and 6
|
Blood samples were collected for the measurement of s-CTx and s-PINP, which are used as biomarkers of bone resorption and formation, respectively.
The median percent change from Baseline in s-CTX and s-PINP markers at Months 1, 3, and 6 was calculated as: (post-Baseline value minus Baseline value) * 100 / Baseline value.
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Baseline; Months 1, 3, and 6
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Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
時間枠：From Baseline up to Month 6
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An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the 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 with hyperbilirubinaemia.
Medical or scientific judgment was to have been exercised in other important medical events.
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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Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6
時間枠：Baseline; Months 1, 3, and 6
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Vital sign values of potential clinical concern were defined as: change in heart rate >30 beats per minutes (bpm), change in systolic blood pressure (SBP) >30 millimeters of mercury (mmHg), and change in diastolic blood pressure (DBP) >20 mmHg.
The number of participants with post-Baseline vital sign values of potential clinical concern who did not have values of potential clinical concern at Baseline are summarized.
If the change from Baseline is a decrease greater than the threshold, it is categorized as "low."
If the change from Baseline is an increase greater than the threshold, it is categorized ad "high."
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Baseline; Months 1, 3, and 6
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Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6
時間枠：Month 6
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The number of participants with laboratory parameter values of potential clinical concern at Month 6 are summarized.
The following are the laboratory values of potential clinical concern: alkaline phosphatase, High: >375 units/Liter (L); aspartate aminotransferase, High: >165 units/L; creatinine, High: >159 micromoles (µmol)/L; glucose, Low: <3 millimoles (mmol)/L; hematocrit, Low: <0.325; hemoglobin, Low: <91grams/L; phosphorus, High: >1.723 mmol/L; potassium, High: >6.3 mmol/L; sodium, Low: <130 mmol/L; total neutrophils, Low: <0.9 10^9 cells (GI)/L; blood urea nitrogen (BUN), High: >21mmol/L; uric acid, High: 654 µmol/L.
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Month 6
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Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of albumin/globulin ratio and BUN/creatinine ratio values.
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 Concentration (Conc.), and Total Protein at Month 6
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of albumin, hemoglobin, mean corpuscle hemoglobin concentration, and total protein values.
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, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6
時間枠：Baseline and Month 6
|
Blood samples were collected for the measurement of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatinine kinase, gamma glutamyl transferase, and lactate dehydrogenase values.
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, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of basophil, eosinophil, lymphocyte, monocyte, segmented neutrophil, total neutrophil, platelet count, and white blood cell count values.
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
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, creatinine, and uric acid values.
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, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of calcium corrected, calcium, chloride, glucose, potassium, magnesium, sodium, phosphorus inorganic, triglyceride, urea/BUN, and VLDL cholesterol calculation values.
Change from Baseline was calcualted 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
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of hematocrit values.
Change from Baseline was calculated as the Month 6 value minuse 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
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of hemoglobin values.
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
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of mean corpuscular volume values.
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
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of red blood cell count values.
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
時間枠：Baseline and Month 6
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Blood samples were collected for the measurement of red cell distribution width values.
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 at Month 6
時間枠：Month 6
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The number of participants with positive and negative results for both neutralizing antibodies to denosumab and for binding antibodies to denosumab at Month 6 are summarized.
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Month 6
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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
2012年1月1日
一次修了 (実際)
2013年2月1日
研究の完了 (実際)
2013年2月1日
試験登録日
最初に提出
2011年12月15日
QC基準を満たした最初の提出物
2011年12月15日
最初の投稿 (見積もり)
2011年12月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年2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1月9日
最終確認日
2013年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。