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- Ensayo clínico NCT01457950
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
17 de abril de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
135
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Busan, Corea, república de, 602-739
- GSK Investigational Site
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Daegu, Corea, república de
- GSK Investigational Site
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Gwangju, Corea, república de, 501-757
- GSK Investigational Site
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Seoul, Corea, república de, 120-752
- GSK Investigational Site
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Seoul, Corea, república de, 137-701
- GSK Investigational Site
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Seoul, Corea, república de, 110-744
- GSK Investigational Site
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Seoul, Corea, república de, 135-710
- GSK Investigational Site
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Seoul, Corea, república de, 100-380
- GSK Investigational Site
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Suwon, Corea, república de, 443-721
- GSK Investigational Site
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songpa-gu, Seoul, Corea, república de, 138-736
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
60 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 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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Comparador de placebos: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab
Periodo de tiempo: 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
Periodo de tiempo: Month 6 and Month 12
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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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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Baseline and Month 12
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Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo
Periodo de tiempo: Month 6 and Month 12
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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 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12
Periodo de tiempo: 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
Periodo de tiempo: 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 Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12
Periodo de tiempo: 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
Periodo de tiempo: 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 Hematocrit at Month 12
Periodo de tiempo: 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 Mean Corpuscle Hemoglobin at Month 12
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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Month 12
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2011
Finalización primaria (Actual)
1 de diciembre de 2012
Finalización del estudio (Actual)
1 de junio de 2013
Fechas de registro del estudio
Enviado por primera vez
20 de octubre de 2011
Primero enviado que cumplió con los criterios de control de calidad
20 de octubre de 2011
Publicado por primera vez (Estimar)
24 de octubre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
17 de abril de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 114163
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Osteoporosis Posmenopáusica
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Radius Health, Inc.TerminadoOsteoporosis | Riesgo de osteoporosis | Osteoporosis Posmenopáusica | Fractura de osteoporosis | Osteoporosis relacionada con la edad | Osteoporosis localizada en la columna vertebral | Osteoporosis senil | Osteoporosis de vértebras | Osteoporosis VertebralEstados Unidos
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AmgenTerminadoOsteoporosis posmenopáusica (OPM)Japón
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Appalachian State UniversityNorth Carolina Agriculture & Technical State UniversityTerminadoOsteoporosis posmenopáusica | Osteoporosis, OsteopeniaEstados Unidos
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Deltanoid PharmaceuticalsTerminadoOsteoporosis posmenopáusica, sitios múltiples
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Radius Health, Inc.TerminadoOsteoporosis | Osteoporosis relacionada con la edad | Osteoporosis relacionada con la edad | Osteoporosis localizada en la columna vertebral | Osteoporosis senil | Osteoporosis de vértebrasEstados Unidos, Polonia, Italia
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Organon and CoTerminadoOsteoporosis posmenopáusica
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AmgenTerminadoOsteoporosis posmenopáusicaEstados Unidos, Canadá, Dinamarca, Alemania, Bélgica, Colombia, Chequia, Japón, México, Polonia, Suiza, Hungría, España, Australia, Rumania, Reino Unido, India, Argentina, Brasil, República Dominicana, Estonia, Letonia, Lituania, Nueva Zelanda
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Penn State UniversityCalifornia Dried Plum BoardActivo, no reclutando
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Massachusetts General HospitalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)TerminadoOsteoporosis posmenopáusicaEstados Unidos
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Sahlgrenska University Hospital, SwedenBioGaia ABTerminadoOsteoporosis posmenopáusicaSuecia
Ensayos clínicos sobre denosumab
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Borstkanker Onderzoek GroepAmgenRetirado
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AmgenTerminadoVoluntario SaludableEstados Unidos
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AmgenTerminadoOsteoporosis | Osteopenia | Baja densidad mineral ósea | Masa ósea baja | Hombres con osteoporosis
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AmgenTerminadoOsteoporosis posmenopáusicaEstados Unidos, Dinamarca, Polonia, Canadá
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Samsung Bioepis Co., Ltd.TerminadoOsteoporosis posmenopáusicaPolonia
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Swiss Group for Clinical Cancer ResearchActivo, no reclutandoCáncer de mama metastásico | Metástasis óseas | Cáncer de próstata metastásicoSuiza, Alemania, Austria
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National Cancer Institute (NCI)TerminadoCarcinoma de ovarioEstados Unidos, Israel
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Luye Pharma Group Ltd.ParexelTerminado
-
Children's Oncology GroupNational Cancer Institute (NCI)TerminadoOsteosarcoma recurrente | Osteosarcoma refractario | Osteosarcoma en estadio IV AJCC v7 | Etapa IVA Osteosarcoma AJCC v7 | Etapa IVB Osteosarcoma AJCC v7 | Osteosarcoma metastásicoEstados Unidos, Canadá, Puerto Rico