Low Bone Mass, Low Bone Mineral Density, Osteoporosis, Postmenopausal Osteoporosis
Conditions
Brief summary
To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Participants randomized to either denosumab or placebo in the 20050179 (NCT00293813) study who completed that study (ie, attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the patient's 20050179 end of study visit.
Interventions
Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.
Bone densitometry assessments of the forearm by DXA on day 1.
BIOLOGICALDenosumab
Denosumab 60 mg subcutaneously every 6 months in the previous study
DRUGPlacebo
Placebo to denosumab subcutaneously every 6 months in the previous study
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Ambulatory, postmenopausal women * Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, attended an end of study visit) * At least 12 months have elapsed since their end of 20050179 study visit * Provide signed informed consent
Exclusion criteria
* Subjects who failed to receive both doses of denosumab (or SQ \[subcutaneous\] placebo) during the 20050179 study * Subjects who were randomized to the alendronate arm during the 20050179 study * Subjects diagnosed with any of the following conditions following completion of the 20050179 study: * Hyperthyroidism * Hyperparathyroidism * Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma) * Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy * Other diseases which affect bone metabolism * Self-reported alcohol or drug abuse within the previous 12 months * Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures * Received any investigational product other than denosumab in two years before the screening visit. * Received \> 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study. * Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone. * Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT | 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. | 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. |
| Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT | 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. | 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. |
| Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT | 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. | 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. |
| Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT | 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. | 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. |
| Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT | 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. | 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. |
| Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT | 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. | 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. |
| Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA | 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. | 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. |
| Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA | 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. | 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. |
| Percent Change of Total Radius BMD From the Parent Study Baseline by DXA | 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. | 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. |
| Actual Value of Serum Type I C-telopeptide | Day 1 | 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). |
| Actual Value of Procollagen Type 1 N-terminal Peptide | Day 1 | 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). |
| Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT | 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. | 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. |
Participant flow
Recruitment details
The first subject enrolled on 14-JUL-2009. The last subject enrolled on 12-MAY-2010
Participants by arm
| Arm | Count |
|---|---|
| Previous Placebo Treatment Group Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study. | 39 |
| Previous Denosumab Treatment Group Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study. | 40 |
| Total | 79 |
Baseline characteristics
| Characteristic | Previous Placebo Treatment Group | Previous Denosumab Treatment Group | Total |
|---|---|---|---|
| Age, Continuous | 63.9 Years STANDARD_DEVIATION 5.8 | 63.4 Years STANDARD_DEVIATION 6.5 | 63.7 Years STANDARD_DEVIATION 6.1 |
| Months since last dose in 20050179 | 32.1 Months STANDARD_DEVIATION 2.5 | 32.2 Months STANDARD_DEVIATION 2.7 | 32.1 Months STANDARD_DEVIATION 2.6 |
| Race/Ethnicity, Customized | 39 Participants | 40 Participants | 79 Participants |
| Sex: Female, Male Female | 39 Participants | 40 Participants | 79 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 |
Outcome results
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT | -5.5 Percent change |
| Previous Denosumab Treatment Group | Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT | -1.8 Percent change |
Comparison: 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 interactionp-value: 0.076695% CI: [-0.4, 7.8]ANCOVA
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).
Time frame: Day 1
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Actual Value of Procollagen Type 1 N-terminal Peptide | 49.8 µg/L |
| Previous Denosumab Treatment Group | Actual Value of Procollagen Type 1 N-terminal Peptide | 58.9 µg/L |
Comparison: ANCOVA based on the log transformed actual values 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 time term but without treatment-by-time interaction.p-value: 0.007995% CI: [1, 1.3]ANCOVA
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).
Time frame: Day 1
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Actual Value of Serum Type I C-telopeptide | 0.6 ng/mL |
| Previous Denosumab Treatment Group | Actual Value of Serum Type I C-telopeptide | 0.7 ng/mL |
Comparison: ANCOVA based on the log transformed actual values 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 time term but without treatment-by-time interaction.p-value: 0.059195% CI: [1, 1.3]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT | -1.0 Percent change |
| Previous Denosumab Treatment Group | Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT | -0.0 Percent change |
Comparison: 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 but without treatment-by-time interaction.p-value: 0.022895% CI: [0.1, 1.7]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT | -1.0 Percent change |
| Previous Denosumab Treatment Group | Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT | -0.6 Percent change |
Comparison: 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 but without treatment-by-time interaction.p-value: 0.289795% CI: [-0.4, 1.2]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT | -6.4 Percent change |
| Previous Denosumab Treatment Group | Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT | -4.6 Percent change |
Comparison: 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 time term but without treatment-by-time interaction.p-value: 0.059495% CI: [-0.1, 3.7]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT | -1.6 Percent change |
| Previous Denosumab Treatment Group | Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT | 1.0 Percent change |
Comparison: 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 time term but without treatment-by-time interaction.p-value: 0.003295% CI: [0.9, 4.3]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT | -1.2 Percent change |
| Previous Denosumab Treatment Group | Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT | 0.3 Percent change |
Comparison: 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 time term but without treatment-by-time interaction.p-value: 0.164895% CI: [-0.6, 3.5]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT | 5.1 Percent change |
| Previous Denosumab Treatment Group | Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT | 5.9 Percent change |
Comparison: 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 includes linear, quadratic and cubic time terms but without treatment-by-time interaction.p-value: 0.65695% CI: [-2.5, 4]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT | 2.9 Percent change |
| Previous Denosumab Treatment Group | Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT | 6.8 Percent change |
Comparison: 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 time term but without treatment-by-time interaction.p-value: 0.006795% CI: [1.1, 6.7]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA | -2.0 Percent change |
| Previous Denosumab Treatment Group | Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA | 0.0 Percent change |
Comparison: 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 time term but without treatment-by-time interaction.p-value: 0.018495% CI: [0.4, 3.8]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change of Total Radius BMD From the Parent Study Baseline by DXA | -3.0 Percent change |
| Previous Denosumab Treatment Group | Percent Change of Total Radius BMD From the Parent Study Baseline by DXA | -0.9 Percent change |
Comparison: 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 time term but without treatment-by-time interaction.p-value: 0.003595% CI: [0.7, 3.5]ANCOVA
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.
Time frame: 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.
Population: Participants with observed data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Previous Placebo Treatment Group | Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA | -3.5 Percent change |
| Previous Denosumab Treatment Group | Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA | -1.9 Percent change |
Comparison: 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 time term but without treatment-by-time interaction.p-value: 0.091195% CI: [-0.3, 3.5]ANCOVA