| Primary | Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT | Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
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| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-5.5(-8.3 to -2.8)
- OG001-1.8(-4.8 to 1.2)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| An analysis of covariance model was fit with main effects for randomized treatment in study 20050179, baseline value, time since last subcutaneous dose of denosumab or placebo in study 20050179 as a continuous variable, and the age stratification from 20050179. Model included linear, quadratic and cubic time terms with treatment-by-time interaction | ANCOVA | | 0.0766 | | Mean Difference (Final Values) | 3.7 | | | | 95 | -0.4 | 7.8 | | | | No | Superiority or Other | | |
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| Secondary | Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT | Percent change from the 20050179 Baseline in total BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
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| Secondary | Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT | Percent change from the 20050179 Baseline in cortical BMD at the distal radius as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
| |
| Secondary | Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT | Percent change from the 20050179 Baseline in trabecular BMD at the distal radius as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
| |
| Secondary | Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT | Percent change from the 20050179 Baseline in cortical thickness at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
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| Secondary | Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT | Percent change from the 20050179 Baseline in total BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
| |
| Secondary | Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT | Percent change from the 20050179 Baseline in cortical BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
| |
| Secondary | Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT | Percent change from the 20050179 Baseline in trabecular BMD at the distal tibia as determined by HR-pQCT at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
| |
| Secondary | Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA | Percent change of distal 1/3 radius BMD from the 20050179 Baseline as determined by dual energy X-ray absorptiometry (DXA) at an average of 32 months since last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
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| Secondary | Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA | Percent change of ultradistal radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since last the subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
| |
| Secondary | Percent Change of Total Radius BMD From the Parent Study Baseline by DXA | Percent change of total radius BMD from the 20050179 Baseline as determined by DXA at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179. | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | Percent change | | Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months. | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
| |
| Secondary | Actual Value of Serum Type I C-telopeptide | Actual value of Serum Type I C-telopeptide measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179). | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | ng/mL | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
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| Secondary | Actual Value of Procollagen Type 1 N-terminal Peptide | Actual value of Type 1 N-terminal Peptide as measured from blood samples taken on Day 1 (an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179). | Participants with observed data. | Posted | | Least Squares Mean | 95% Confidence Interval | µg/L | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Previous Placebo Treatment Group | Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | | OG001 | Previous Denosumab Treatment Group | Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. |
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