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This study is to evaluate the efficacy and safety of denosumab 60 milligrams (mg) for 12 month treatment in Chinese postmenopausal women with osteoporosis at increased risk of fracture.
The aim of this Phase III, randomized, double-blind, placebo-controlled, parallel-group study is to evaluate the efficacy and safety of denosumab (DMAb) in Chinese postmenopausal women with osteoporosis at increased risk of fracture. The study design consists of two phases: Screening and 12-month Double-Blind treatment phase. Following the Screening phase, all eligible subjects will be randomized to receive Double-Blind DMAb (60 mg) or Placebo study medication in a 3:1 ratio. DMAb 60 mg and placebo will be administered as a single subcutaneous (SC) injection at the beginning of the Double-Blind phase and at 6 months following the initial dose. All subjects will receive daily supplementation of oral elemental calcium (at least 600 mg) and vitamin D (at least 400 International Units [IU]). The primary objective is to determine the effects of DMAb compared to placebo with respect to mean percent change in BMD at the lumbar spine, as measured by dual-energy x-ray absorptiometry (DXA), from Baseline to Month 12. Secondary objectives include the evaluation between the DMAb and placebo treatment groups: change in BMD: at the lumbar spine (Month 6), total hip (Months 6 and 12), femoral neck (Months 6 and 12) and trochanter (Months 6 and 12); and serum biomarkers of bone formation and resorption (Months 6 and 12). Clinical safety of denosumab will also be assessed in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab 60mg | Experimental | injection |
|
| Placebo | Placebo Comparator | injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12 | Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least one month on-therapy. | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in BMD at the Lumbar Spine at Month 6 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. |
Not provided
Inclusion Criteria:
history of fracture parental history of hip fracture increased bone turnover rate at screening (s-CTX >1.0 SD above the mean in healthy premenopausal women) low body weight (BMI≤19kg/m2) elderly (age≥70y) current smoker
Exclusion Criteria:
Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings.
Paget's disease Cushing's disease Hyperprolactinemia
If TSH level is below normal range, subject is not eligible for the study. If TSH level is elevated (>5.5 μIU/mL and ≤10.0 μIU/mL), serum T4 should be measured.
If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal range, subject is not eligible for the study. If TSH level is > 10.0 μIU/mL, subject is not eligible.
Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5years.
Cirrhosis of the liver Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Chronic stable hepatitis B and C are acceptable if the subject otherwise meets study entry criteria (e.g., presence of hepatitis B surface antigen or positive Hepatitis C test result within 3 months of Screening).
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 which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
Known to have tested positive for human immunodeficiency virus (HIV).
Concomitant Medications:
If used for ≥3 years cumulatively, subject is ineligible.
If used for >3-months but <3 years cumulatively:
If the last dose was <1 year before enrolment, subject is ineligible. If the last dose was ≥1 year before enrolment, subject is eligible. If used ≤3 months, cumulatively, subject is eligible.
Parathyroid hormone (PTH) or PTH derivatives, e.g., teriparatide. Anabolic steroids or testosterone. Glucocorticosteroids (>5 mg prednisone equivalent per day for more than 10 days).
Systemic hormone replacement therapy. Selective estrogen receptor modulators (SERMs), e.g., raloxifene Tibolone. Calcitonin. Calcitriol or vitamin D derivatives. Other bone active drugs including anti-convulsives (except benzodiazepines) and heparin.
Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists.
Serum aspartate aminotransferase (AST) ≥2.0 x upper limits of normal (ULN). Serum alanine aminotransferase (ALT) ≥2.0 x ULN. Alkaline phosphatase and bilirubin ≥1.5 x ULN (isolated bilirubin ≥1.5 ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%.
Less than two lumbar vertebrae evaluable for DXA measurements. Height, weight, or girth which may preclude accurate DXA measurements.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chengdu | Sichuan | 610041 | China | ||
| GSK Investigational Site |
A total of 909 participants were screened, of whom 485 were randomized in a 3: 1 ratio to receive one of the two study treatments. A total of 484 participants received at least single dose of investigational product (IP).
The study design consists of two phases: Screening Phase and 12-month Double-blind Treatment Phase. The Screening Phase was to last up to a maximum of 2.5 months, which was followed by a 12-month Double-blind Treatment Phase. The total participation time in the study was approximately 14.5 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab 60 mg | Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]). |
| FG001 | Placebo | Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase.Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab 60 mg | Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12 | Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least one month on-therapy. | Intent-to-Treat (ITT) Population: all safety Population participants (consisting of all participants who received at least one dose of study medication) who had a Baseline and at least one valid post-Baseline efficacy measure. Participants with values at Baseline and Month 12 were included in the analysis. | Posted | Least Squares Mean | Standard Error | Percentage change | Baseline and Month 12 |
On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of IP through the Study Phase (6 months post-dose) (assessed up to 12 months).
On-treatment SAEs and non-serious AEs are reported for safety population, comprised of all participants randomized to treatment who received at least one dose of IP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Denosumab 60mg | Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any event | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Investigations | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
Injection |
|
| Elemental Calcium | Dietary Supplement | Oral, at least 600 mg |
|
| Vitamin D | Dietary Supplement | Oral, at least 400 IU |
|
| Baseline and Month 6 |
| Percent Change From Baseline in BMD at the Total Hip at Month 6 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | Baseline and Month 6 |
| Percent Change From Baseline in BMD at the Femoral Neck at Month 6 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | Baseline and Month 6 |
| Percent Change From Baseline in BMD at the Trochanter at Month 6 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | Baseline and Month 6 |
| Percent Change From Baseline in BMD at the Total Hip at Month 12 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | Baseline and Month 12 |
| Percent Change From Baseline in BMD at the Femoral Neck at Month 12 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | Baseline and Month 12 |
| Percent Change From Baseline in BMD at the Trochanter at Month 12 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | Baseline and Month 12 |
| Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline to Month 6 and Month 12 | s-CTX is biomarker of bone resorption and formation. s-CTX was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in s-CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals. | Baseline, Month 6 and Month 12 |
| Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline to Month 6 and Month 12 | s-PINP is biomarker of bone resorption and formation. s-PINP was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in serum CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals. | Baseline, Month 6, Month 12 |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 1, Month 3, Month 6, and Month 12 | Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in SBP and DBP was assessed at Baseline, Month 1, Month 3, Month 6, and Month 12. | Baseline, Month 1, Month 3, Month 6 and Month 12 |
| Change From Baseline in Heart Rate at Month 1, Month 3, Month 6, and Month 12 | Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in heart rate was assessed at Baseline, Month 1, Month 3, Month 6 and Month 12. | Baseline, Month 1, Month 3, Month 6 and Month 12 |
| Change From Baseline in Alanine Amino Transferase, Alkaline Phosphatase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Month 1, Month 6 and Month 12 | Baseline values were obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Alanine amino transferase, alkaline phosphatase, aspartate amino transferase, and gamma glutamyl transferase were assessed at Baseline, Month 1, Month 6 and Month 12. | Baseline, Month 1, Month 6, and Month 12 |
| Change From Baseline in Creatine Kinase, Lactate Dehydrogenase at Month 6 and Month 12. | Baseline values was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatine kinase and lactate dehydrogenase were assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12 |
| Change From Baseline in Albumin at Month 1, Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Albumin was assessed at Baseline, Month 1, Month 6 and Month 12. | Baseline, Month 1, Month 6 and Month 12. |
| Change From Baseline in Globulin at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Globulin was assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12 |
| Change From Baseline in Hemoglobin and Total Protein at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Hemoglobin and total protein were assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12 |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils-total Absolute Neutrophil Count (ANC), White Blood Cell Count at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils-total ANC and white blood cell count were assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12 |
| Change From Baseline in Calcium (Corrected), Calcium at Month 1, Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Calcium (corrected) and calcium were assessed at Baseline, Month 1, Month 6 and Month 12. | Baseline, Month 1, Month 6 and Month 12. |
| Change From Baseline in Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Triglycerides, Urea/Blood Urea Nitrogen (BUN) at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Chloride, cholesterol, glucose, magnesium, inorganic phosphorous, potassium, sodium, triglycerides and urea/BUN were assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12 |
| Change From Baseline in Direct Bilirubin, Total Bilirubin at Month 1, Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Direct bilirubin and total bilirubin were assessed at Baseline, Month 1, Month 6 and Month 12. | Baseline, Month 1, Month 6 and Month 12 |
| Change From Baseline in Creatinine and Uric Acid at Month 6 and Month 12 | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatinine and uric acid were assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12 |
| Change From Baseline in Hematocrit at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Hematocrit was assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12. |
| Change From Baseline in Mean Corpuscle Hemoglobin at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle hemoglobin was assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12. |
| Change From Baseline in Mean Corpuscle Volume at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle volume was assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12 |
| Change From Baseline in Red Blood Cell Count at Month 6 and Month 12 | Baseline value was obtained at screening (visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as: Value at Indicated visit minus Baseline value. Blood samples were collected for measurement. Red blood cell count was assessed at Baseline, Month 6 and Month 12. | Baseline, Month 6 and Month 12 |
| Number of Participants With Confirmed Anti-denosumab Antibody Formation at Baseline and Month 12 | Anti-denosumab antibody formation was assessed at Baseline (Visit 3) and Month 12. Binding antibody and neutralizing antibody assays were used to assess number of participants with anti-denosumab antibody. | Baseline and Month 12 |
| Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events) | 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. A serious adverse event (SAE) is 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, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, serious non-fatal AEs, serious fatal AEs have been presented. | From start of IP through the Study Phase (6 months post-dose) (assessed up to 12 months) |
| Chengdu |
| Sichuan |
| 610072 |
| China |
| GSK Investigational Site | Beijing | 100035 | China |
| GSK Investigational Site | Beijing | 100050 | China |
| GSK Investigational Site | Beijing | 100730 | China |
| GSK Investigational Site | Chengdu | 610083 | China |
| GSK Investigational Site | Shanghai | 200040 | China |
| GSK Investigational Site | Shanghai | 200233 | China |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Placebo |
Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
|
|
|
|
| Secondary | Percent Change From Baseline in BMD at the Lumbar Spine at Month 6 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | ITT Population. Participants with values at Baseline and Month 6 were included in the analysis. | Posted | Least Squares Mean | Standard Error | Percentage change | Baseline and Month 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in BMD at the Total Hip at Month 6 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | ITT Population. Participants with values at Baseline and Month 6 were included in the analysis. | Posted | Least Squares Mean | Standard Error | Percentage change | Baseline and Month 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in BMD at the Femoral Neck at Month 6 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | ITT Population. Participants with values at Baseline and Month 6 were included in the analysis. | Posted | Least Squares Mean | Standard Error | Percentage change | Baseline and Month 6 |
|
|
|
|
| Secondary | Percent Change From Baseline in BMD at the Trochanter at Month 6 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | ITT Population. Participants with values at Baseline and Month 6 were included in the analysis. | Posted | Least Squares Mean | Standard Error | Percentage change | Baseline and Month 6 |
|
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|
|
| Secondary | Percent Change From Baseline in BMD at the Total Hip at Month 12 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | ITT Population. Participants with values at Baseline and Month 12 were included in the analysis. | Posted | Least Squares Mean | Standard Error | Percentage change | Baseline and Month 12 |
|
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| Secondary | Percent Change From Baseline in BMD at the Femoral Neck at Month 12 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | ITT Population. Participants with values at Baseline and Month 12 were included in the analysis. | Posted | Least Squares Mean | Standard Error | Percentage change | Baseline and Month 12 |
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| Secondary | Percent Change From Baseline in BMD at the Trochanter at Month 12 | BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy. | ITT Population. Participants with values at Baseline and Month 12 were included in the analysis. | Posted | Least Squares Mean | Standard Error | Percentage change | Baseline and Month 12 |
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| Secondary | Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline to Month 6 and Month 12 | s-CTX is biomarker of bone resorption and formation. s-CTX was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in s-CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals. | ITT Population. Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles). | Posted | Median | Inter-Quartile Range | Percentage change | Baseline, Month 6 and Month 12 |
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| Secondary | Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline to Month 6 and Month 12 | s-PINP is biomarker of bone resorption and formation. s-PINP was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in serum CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals. | ITT Population: Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles). | Posted | Median | Inter-Quartile Range | Percentage change | Baseline, Month 6, Month 12 |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 1, Month 3, Month 6, and Month 12 | Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in SBP and DBP was assessed at Baseline, Month 1, Month 3, Month 6, and Month 12. | Safety Population: all participants who received at least one dose of study medication. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline, Month 1, Month 3, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Heart Rate at Month 1, Month 3, Month 6, and Month 12 | Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in heart rate was assessed at Baseline, Month 1, Month 3, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Beats per minute | Baseline, Month 1, Month 3, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Alanine Amino Transferase, Alkaline Phosphatase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Month 1, Month 6 and Month 12 | Baseline values were obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Alanine amino transferase, alkaline phosphatase, aspartate amino transferase, and gamma glutamyl transferase were assessed at Baseline, Month 1, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | International unit per liter (IU/L) | Baseline, Month 1, Month 6, and Month 12 |
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| Secondary | Change From Baseline in Creatine Kinase, Lactate Dehydrogenase at Month 6 and Month 12. | Baseline values was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatine kinase and lactate dehydrogenase were assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | International unit per liter (IU/L) | Baseline, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Albumin at Month 1, Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Albumin was assessed at Baseline, Month 1, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Gram per liter (G/L) | Baseline, Month 1, Month 6 and Month 12. |
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| Secondary | Change From Baseline in Globulin at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Globulin was assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Grams per liter (G/L) | Baseline, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Hemoglobin and Total Protein at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Hemoglobin and total protein were assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Grams per liter (G/L) | Baseline, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils-total Absolute Neutrophil Count (ANC), White Blood Cell Count at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils-total ANC and white blood cell count were assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Giga per liter (GI/L) | Baseline, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Calcium (Corrected), Calcium at Month 1, Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Calcium (corrected) and calcium were assessed at Baseline, Month 1, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline, Month 1, Month 6 and Month 12. |
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| Secondary | Change From Baseline in Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Triglycerides, Urea/Blood Urea Nitrogen (BUN) at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Chloride, cholesterol, glucose, magnesium, inorganic phosphorous, potassium, sodium, triglycerides and urea/BUN were assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Direct Bilirubin, Total Bilirubin at Month 1, Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Direct bilirubin and total bilirubin were assessed at Baseline, Month 1, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per liter (UMOL/L) | Baseline, Month 1, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Creatinine and Uric Acid at Month 6 and Month 12 | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatinine and uric acid were assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Micromoles per liter (UMOL/L) | Baseline, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Hematocrit at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Hematocrit was assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Ratio | Baseline, Month 6 and Month 12. |
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| Secondary | Change From Baseline in Mean Corpuscle Hemoglobin at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle hemoglobin was assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Picograms (PG) | Baseline, Month 6 and Month 12. |
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| Secondary | Change From Baseline in Mean Corpuscle Volume at Month 6 and Month 12. | Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle volume was assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Femtoliter (FL) | Baseline, Month 6 and Month 12 |
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| Secondary | Change From Baseline in Red Blood Cell Count at Month 6 and Month 12 | Baseline value was obtained at screening (visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as: Value at Indicated visit minus Baseline value. Blood samples were collected for measurement. Red blood cell count was assessed at Baseline, Month 6 and Month 12. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Mean | Standard Deviation | Trillion cells per liter (TI/L) | Baseline, Month 6 and Month 12 |
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| Secondary | Number of Participants With Confirmed Anti-denosumab Antibody Formation at Baseline and Month 12 | Anti-denosumab antibody formation was assessed at Baseline (Visit 3) and Month 12. Binding antibody and neutralizing antibody assays were used to assess number of participants with anti-denosumab antibody. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Posted | Number | Participants | Baseline and Month 12 |
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| Secondary | Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events) | 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. A serious adverse event (SAE) is 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, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, serious non-fatal AEs, serious fatal AEs have been presented. | Safety Population. Two participants randomized to placebo group received denosumab by mistake. | Posted | Number | Participants | From start of IP through the Study Phase (6 months post-dose) (assessed up to 12 months) |
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| 11 |
| 367 |
| 43 |
| 367 |
| EG001 | Placebo | Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU). | 3 | 117 | 24 | 117 |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Any event | Cardiac disorders | MedDRA | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
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| Any event | Infections and infestations | MedDRA | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA | Systematic Assessment |
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| Any event | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Any event | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Any event | Nervous system disorders | MedDRA | Systematic Assessment |
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| Brain stem infarction | Nervous system disorders | Brain stem infarctio | Systematic Assessment |
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| Any event | General disorders | MedDRA | Systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
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| Bone density decreased | Investigations | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region
| 95 |
| No |
| Superiority or Other |
Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region
| 95 |
| No |
| Superiority or Other |
Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region
| 95 |
| No |
| Superiority or Other |
Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region
| 95 |
| No |
| Superiority or Other |
Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region
| 95 |
| No |
| Superiority or Other |
Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region
| 95 |
| No |
| Superiority or Other |
Treatment By Region Interaction: Based on ANCOVA, Percent change from Baseline = Baseline + treatment + region + treatment by region
| 95 |
| No |
| Superiority or Other |
| <0.0001 |
Two-Sided, Wilcoxon t Approximation |
| Hodges Lehmann Estimate of Difference |
| -52.56 |
| 95 |
| -59.38 |
| -46.17 |
s-CTX at Month 12 |
| No |
| Superiority or Other |
| <0.0001 |
Two-Sided, Wilcoxon t Approximation |
| Hodges Lehmann Estimate of Difference |
| -51.21 |
| 2-Sided |
| 95 |
| -56.26 |
| -45.91 |
s-PINP at Month 12 |
| No |
| Superiority or Other |
| SBP, Month 6, n = 350, 114 |
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| SBP, Month 12, n = 342, 110 |
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| DBP, Month 1, n = 365, 117 |
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| DBP, Month 3, n = 362, 117 |
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| DBP, Month 6, n = 350, 114 |
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| DBP, Month 12, n = 342, 110 |
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| Heart Rate, Month 6, n = 350, 114 |
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| Heart Rate, Month 12, n = 342, 110 |
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| Alanine Amino Transferase, Month 12, n = 340, 109 |
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| Alkaline Phosphatase, Month 1, n = 365, 117 |
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| Alkaline Phosphatase, Month 6, n = 350, 114 |
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| Alkaline Phosphatase, Month 12, n = 340, 109 |
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| Aspartate Amino Transferase, Month 1, n = 365, 117 |
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| Aspartate Amino Transferase, Month 6, n = 350, 114 |
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| Aspartate Amino Transferase,Month 12, n = 340, 109 |
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| Gamma Glutamyl Transferase, Month 1, n = 365, 117 |
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| Gamma Glutamyl Transferase, Month 6, n = 350, 114 |
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| Gamma Glutamyl Transferase, Month 12, n = 340, 109 |
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| Lactate Dehydrogenase, Month 6, n = 350, 114 |
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| Lactate Dehydrogenase, Month 12, n = 340, 109 |
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| Albumin, Month 12, n = 340, 109 |
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| Total Protein, Month 6, n = 350, 114 |
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| Total Protein, Month 12, n = 340, 109 |
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| Eosinophils, Month 6, n = 346, 113 |
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| Eosinophils, Month 12, n = 339, 109 |
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| Lymphocytes, Month 6, n = 346, 113 |
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| Lymphocytes, Month 12, n = 339, 109 |
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| Monocytes, Month 6, n = 346, 113 |
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| Monocytes, Month 12, n = 339, 109 |
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| Platelet count, Month 6, n = 345, 113 |
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| Platelet count, Month 12, n = 337, 109 |
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| Total ANC, Month 6, n = 346, 113 |
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| Total ANC, Month 12, n = 339, 109 |
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| White Blood Cell count, Month 6, n = 346, 113 |
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| White Blood Cell count, Month 12, n = 339, 109 |
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| Calcium (corrected), Month 12, n = 340, 109 |
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| Calcium, Month 1, n = 365, 117 |
|
| Calcium, Month 6, n = 350, 114 |
|
| Calcium, Month 12, n = 340, 109 |
|
| Cholesterol, Month 6, n = 350, 114 |
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| Cholesterol, Month 12, n = 340, 109 |
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| Glucose, Month 6, n = 350, 114 |
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| Glucose, Month 12, n = 340, 109 |
|
| Magnesium, Month 6, n = 350, 114 |
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| Magnesium, Month 12, n = 340, 109 |
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| Phosphorus, inorganic, Month 6, n = 350, 114 |
|
| Phosphorus, inorganic, Month 12, n = 340, 109 |
|
| Potassium, Month 6, n = 350, 114 |
|
| Potassium, Month 12, n = 340, 109 |
|
| Sodium, Month 6, n = 350, 114 |
|
| Sodium, Month 12, n = 340, 109 |
|
| Triglycerides, Month 6, n = 350, 114 |
|
| Triglycerides, Month 12, n = 340, 109 |
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| Urea/BUN, Month 6, n = 350, 114 |
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| Urea/BUN, Month 12, n = 340, 109 |
|
| Direct Bilirubin, Month 12, n = 340, 109 |
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| Total Bilirubin, Month 1, n = 365, 117 |
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| Total Bilirubin, Month 6, n = 350, 114 |
|
| Total Bilirubin, Month 12, n = 340, 109 |
|
| Uric acid, Month 6, n = 350, 114 |
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| Uric acid, Month 12, n = 340, 109 |
|
| Neutralising antibody detection,Month 12, n = 1,0 |
|
| Any Serious Fatal AEs |
|