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

9 de enero de 2014 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

250

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

  • India
      • Ahmedabad, India, 380015
        • GSK Investigational Site
      • Bangalore, India, 560043
        • GSK Investigational Site
      • Bangalore, India, 560052
        • GSK Investigational Site
      • Bangalore, India, 560054
        • GSK Investigational Site
      • Delhi, India, 110060
        • GSK Investigational Site
      • Mangalore, India, 575002
        • GSK Investigational Site
      • Nagpur, India, 440010
        • GSK Investigational Site
      • Nagpur, India, 440012
        • GSK Investigational Site
      • Pune, India, 411030
        • GSK Investigational Site
      • Trivandrum, India, 695011
        • GSK Investigational Site
      • Vadodra, India, 390007
        • GSK Investigational Site

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

55 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

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)

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 treatment
Droga: denosumab
60mg subcutaneous injection, single dose
Comparador de placebos: Arm 2
placebo subcutaneous injection, single dose at the start of the 6-month double-blind treatment
Droga: placebo
placebo subcutaneous injection, single dose

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6
Periodo de tiempo: Baseline and Month 6
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).
Baseline and Month 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6
Periodo de tiempo: 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).
Baseline and Month 6
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
Periodo de tiempo: 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.
Baseline; Months 1, 3, and 6
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
Periodo de tiempo: From Baseline up to Month 6
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.
From Baseline up to Month 6
Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6
Periodo de tiempo: Baseline; Months 1, 3, and 6
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."
Baseline; Months 1, 3, and 6
Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6
Periodo de tiempo: Month 6
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.
Month 6
Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6
Periodo de tiempo: Baseline and Month 6
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.
Baseline and Month 6
Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6
Periodo de tiempo: Baseline and Month 6
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.
Baseline and Month 6
Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6
Periodo de tiempo: 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.
Baseline and Month 6
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6
Periodo de tiempo: Baseline and Month 6
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.
Baseline and Month 6
Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6
Periodo de tiempo: Baseline and Month 6
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.
Baseline and Month 6
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
Periodo de tiempo: Baseline and Month 6
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.
Baseline and Month 6
Change From Baseline in Hematocrit at Month 6
Periodo de tiempo: Baseline and Month 6
Blood samples were collected for the measurement of hematocrit values. Change from Baseline was calculated as the Month 6 value minuse the Baseline value.
Baseline and Month 6
Change From Baseline in Mean Corpuscle Hemoglobin at Month 6
Periodo de tiempo: Baseline and Month 6
Blood samples were collected for the measurement of hemoglobin values. 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
Periodo de tiempo: Baseline and Month 6
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.
Baseline and Month 6
Change From Baseline in Red Blood Cell Count at Month 6
Periodo de tiempo: Baseline and Month 6
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.
Baseline and Month 6
Change From Baseline in Red Cell Distribution Width at Month 6
Periodo de tiempo: Baseline and Month 6
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.
Baseline and Month 6
Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 6
Periodo de tiempo: Month 6
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.
Month 6

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

GlaxoSmithKline

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 enero de 2012

Finalización primaria (Actual)

1 de febrero de 2013

Finalización del estudio (Actual)

1 de febrero de 2013

Fechas de registro del estudio

Enviado por primera vez

15 de diciembre de 2011

Primero enviado que cumplió con los criterios de control de calidad

15 de diciembre de 2011

Publicado por primera vez (Estimar)

19 de diciembre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

7 de febrero de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

9 de enero de 2014

Última verificación

1 de diciembre de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 114161

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. .

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