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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind treatment |
|
| Arm 2 | Placebo Comparator | placebo subcutaneous injection, single dose at the start of the 6-month double-blind treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| denosumab | Drug | 60mg subcutaneous injection, single dose |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6 | BMD at the total hip, femoral neck, and trochanter was measured by the DXA scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an ANCOVA model with terms for treatment and corresponding Baseline BMD (as a continuous covariate). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ahmedabad | 380015 | India | |||
| GSK Investigational Site |
The study consisted of a Screening Phase of up to 2.5 months and a 6-month Double-blind Treatment Phase. A total of 551 participants (par.) were screened; 303 par. were screen failures, and 250 par. were randomized (2 par. were considered to be screen failures; however, these par. were randomized, 1 to each treatment group).
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab 60 mg | Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]). |
| FG001 | Placebo | Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 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 denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [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 | Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at 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). | Intent-to-Treat Efficacy (ITTE) Population: all randomized participants who received one dose of study medication, and who had a Baseline measure and at least one post-Baseline efficacy measure during the Double-blind Treatment Phase. Only participants with BMD values at both Baseline and Month 6 were analyzed. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and Month 6 |
|
SAEs (serious adverse events) and non-serious AEs were collected from the start of study medication through the study period (6-month post-dose) (up to Study Week 43).
AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who received one dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Denosumab 60 mg | Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 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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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
placebo subcutaneous injection, single dose |
|
| 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Bangalore |
| 560043 |
| India |
| GSK Investigational Site | Bangalore | 560052 | India |
| GSK Investigational Site | Bangalore | 560054 | India |
| GSK Investigational Site | Delhi | 110060 | India |
| GSK Investigational Site | Mangalore | 575002 | India |
| GSK Investigational Site | Nagpur | 440010 | India |
| GSK Investigational Site | Nagpur | 440012 | India |
| GSK Investigational Site | Pune | 411030 | India |
| GSK Investigational Site | Trivandrum | 695011 | India |
| GSK Investigational Site | Vadodra | 390007 | India |
| Withdrawal by Subject |
|
| Placebo |
Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 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 |
|
Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
| OG001 | Placebo | Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). |
|
|
|
| Secondary | Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at 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). | ITTE Population. Only participants with BMD values at both Baseline and Month 6 were analyzed. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and Month 6 |
|
|
|
| Secondary | 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 | 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. | ITTE Population. Only participants with s-CTX and s-PINP values at both Baseline and Months 1, 3, and 6 were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITTE Population. | Posted | Median | Inter-Quartile Range | percent change | Baseline; Months 1, 3, and 6 |
|
|
|
| Secondary | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) | 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. | ITT Population: all participants who received one dose of study medication | Posted | Number | participants | From Baseline up to Month 6 |
|
|
|
| Secondary | Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at 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." | ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population. | Posted | Number | participants | Baseline; Months 1, 3, and 6 |
|
|
|
| Secondary | Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at 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. | ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population. | Posted | Number | participants | Month 6 |
|
|
|
| Secondary | Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at 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. | ITT Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | ratio | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at 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. | ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population. | Posted | Mean | Standard Deviation | grams per liter (g/L) | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at 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. | ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count 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. | ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population. | Posted | Mean | Standard Deviation | 10^9 cells per liter (GI/L) | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at 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. | ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population. | Posted | Mean | Standard Deviation | micromoles per liter (UMOL/L) | Baseline and Month 6 |
|
|
|
| Secondary | 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 | 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. | ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population. | Posted | Mean | Standard Deviation | millimoles per liter (MMOL/L) | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Hematocrit at 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. | ITT Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | proportion of RBCs in blood | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Mean Corpuscle Hemoglobin at 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. | ITT Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | picograms | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Mean Corpuscular Volume at 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. | ITT Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | femtoliters | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Red Blood Cell Count at 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. | ITT Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | 10^12 cells per liter (TI/L) | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Red Cell Distribution Width at 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. | ITT Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | percentage | Baseline and Month 6 |
|
|
|
| Secondary | Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at 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. | ITT Population. Only participants available at the specified time point were analyzed. | Posted | Number | participants | Month 6 |
|
|
|
| 1 |
| 124 |
| 8 |
| 124 |
| EG001 | Placebo | Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). | 3 | 126 | 3 | 126 |
| Varicose vein ruptured | Vascular disorders | MedDRA | Systematic Assessment |
|
| Cataract nuclear | Eye disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA | Systematic Assessment |
|
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 |
| Trochanter |
|
| s-CTx, Month 6, n=105, 113 |
|
| s-PINP, Month 1, n=110, 120 |
|
| s-PINP, Month 3, n=107, 111 |
|
| s-PINP, Month 6, n=104, 113 |
|
| DBP, Month 3: High, n=117, 120 |
|
| DBP, Month 3: Low, n=117, 120 |
|
| DBP, Month 6: Low, n=111, 114 |
|
| SBP, Month 1: Low, n=122, 125 |
|
| SBP, Month 3: High, n=117, 120 |
|
| SBP, Month 3: Low, n=117, 120 |
|
| SBP, Month 6: Low, n=111, 114 |
|
| Heart Rate, Month 3: Low, n=117, 120 |
|
| Creatinine: High, n=107, 114 |
|
| Glucose: Low, n=107, 114 |
|
| Hematocrit: Low, n=106, 111 |
|
| Hemoglobin: Low, n=106, 111 |
|
| Inorganic Phosphorus: High, n=107, 114 |
|
| Potassium: High, n=107, 113 |
|
| Sodium: Low, n=107, 114 |
|
| Total Neutrophils: Low, n=104, 107 |
|
| Urea/BUN: High, n=107, 114 |
|
| Uric Acid: High, n=107, 114 |
|
| Mean corpuscle hemoglobin conc., n=106, 107 |
|
| Total protein, n=106, 114 |
|
| Aspartate amino transferase, 106, 113 |
|
| Creatinine kinase, n=106, 114 |
|
| Gamma glutamyl transferase, n=106, 114 |
|
| Lactate dehydrogenase, n=106, 113 |
|
| Lymphocytes, n=104, 103 |
|
| Monocytes, n=104, 103 |
|
| Segmented neutrophils, n=104, 103 |
|
| Total neutrophils, n=104, 103 |
|
| Platelet count, n=103, 105 |
|
| White blood cell count, n=104, 103 |
|
| Total bilirubin, n=106, 114 |
|
| Creatinine, n=106, 114 |
|
| Uric acid, n=106, 114 |
|
| Chloride, n=106, 114 |
|
| Glucose, n=106, 113 |
|
| Potassium, n=106, 113 |
|
| Magnesium, n=106, 114 |
|
| Sodium, n=106, 114 |
|
| Phosphorus inorganic, n=106, 114 |
|
| Triglycerides, n=106, 114 |
|
| Urea/BUN, n=106, 114 |
|
| VLDL cholesterol calculation, n=103, 109 |
|
| Title | Measurements |
|---|
|
| Binding antibodies, Negative, n=110, 114 |
|