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A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab

17. dubna 2014 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

135

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

60 let až 90 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Arm 1
denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase
Lék: denosumab
double-blind phase: 60mg subcutaneous injection, single dose
Komparátor placeba: Arm 2
placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase
Lék: placebo
double-blind phase: placebo subcutaneous injection, single dose
Experimentální: 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
Lék: open-label denosumab
open-label phase: 60mg subcutaneous injection, single dose

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

GlaxoSmithKline

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. listopadu 2011

Primární dokončení (Aktuální)

1. prosince 2012

Dokončení studie (Aktuální)

1. června 2013

Termíny zápisu do studia

První předloženo

20. října 2011

První předloženo, které splnilo kritéria kontroly kvality

20. října 2011

První zveřejněno (Odhad)

24. října 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

7. května 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. dubna 2014

Naposledy ověřeno

1. února 2014

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

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