Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor. To evaluate the difference between 2 groups in the primary efficacy endpoint, the percent change from baseline in BMD for lumbar spine (L1 to L4) by DXA at Week 52 was analyzed using an analysis of covariance (ANCOVA) model coupled with multiple imputation assuming the data to be missing at random (MAR).

The FAS was defined as all participants who received at least 1 full dose of the study drug (CT-P41 or US-licensed Prolia). The total number of participants in FAS was 239 and 238 in the CT-P41 and US-licensed Prolia groups, respectively. The overall number of participants analyzed represents the number of participants in FAS who had a BMD assessment result for the lumbar spine by DXA at Week 52.

Bone mineral density was assessed by DXA and assessments of the lumbar spine (L1 to L4), total hip, and femoral neck were performed at a central imaging vendor.

The overall number of participants analyzed row represents the total number of participants in the FAS. The number analyzed per row represents the number of participants in FAS with lumbar spine, total hip, or femoral neck BMD value at baseline and Week 52.

Bone mineral density was assessed by DXA and assessments of the lumbar spine (L1 to L4), total hip, and femoral neck BMD were performed at a central imaging vendor.

The FAS-TP II subset was defined as all participants in FAS who received 1 full dose of the study drug (CT-P41 or US-licensed Prolia) at Week 52. The overall number of participants analyzed row represents the total number of participants in the FAS-TP II subset. The number analyzed per row represents the number of participants in FAS-TP II subset with lumbar spine, total hip, or femoral neck BMD value at baseline and Week 78.

Efficacy analysis of new vertebral fractures included only vertebral fractures occurring from T4 to L4 and confirmed by the central imaging vendor. A new vertebral fracture was defined as an increase of ≥1 grade in any vertebra from T4 to L4 that was normal at screening.

The nonvertebral fractures endpoint included fractures other than those of the vertebrae, excluding the skull, facial bones, mandible, metacarpals, and phalanges (fingers or toes) since they are not associated with decreased BMD, and excluded pathologic fractures and those associated with severe trauma acquired from a fall (from a height higher than a stool, chair, or first rung of a ladder) or otherwise. Only nonvertebral fractures confirmed by the central imaging vendor were included in the efficacy analysis.

The fractures occurring at the site of femur neck, femur intertrochanter, or femur subtrochanter were considered as a hip fracture.

The overall number of participants analyzed and the number analyzed represents the total number of participants in FAS.

Efficacy analysis of new vertebral fractures included only vertebral fractures occurring from T4 to L4 and confirmed by the central imaging vendor. A new vertebral fracture was defined as an increase of ≥1 grade in any vertebra from T4 to L4 that was normal at screening.

The nonvertebral fractures endpoint included fractures other than those of the vertebrae, excluding the skull, facial bones, mandible, metacarpals, and phalanges (fingers or toes) since they are not associated with decreased BMD, and excluded pathologic fractures and those associated with severe trauma acquired from a fall (from a height higher than a stool, chair, or first rung of a ladder) or otherwise. Only nonvertebral fractures confirmed by the central imaging vendor were included in the efficacy analysis.

The fractures occurring at the site of femur neck, femur intertrochanter, or femur subtrochanter were considered as a hip fracture.

The overall number of participants analyzed and the number analyzed represents the total number of participants in FAS-TP II subset.

The Ctrough, a concentration before the next study drug administration, was calculated by non-compartmental analysis method from the concentration-time data. All serum concentrations below the lower limit of quantification (LLoQ) was set to 0 in the descriptive summaries of PK parameter estimation. In TP I, the Ctrough of denosumab at Weeks 0 and 26 was assessed as the serum concentration at Weeks 26 and 52 before the study drug administration, respectively.

The PK Set was defined as all participants who received at least 1 full dose of the study drug (CT-P41 or US-licensed Prolia) and had at least 1 post-treatment PK concentration data with a concentration above the LLoQ prior to dosing at Week 52. The overall number of participants analyzed row represents the total number of participants in PK Set. The number analyzed per row represents the number of participants in PK set with data at the corresponding time point.

The Ctrough, a concentration before the next study drug administration, was calculated by non-compartmental analysis method from the concentration-time data. All serum concentrations below the LLoQ was set to 0 in the descriptive summaries of PK parameter estimation. In TP II, the Ctrough of denosumab at Week 52 was assessed as the serum concentration at Week 78.

The PK-TP II subset was defined as all participants in the PK set who received 1 full dose of the study drug (CT-P41 or US-licensed Prolia) at Week 52 and had at least 1 post-treatment PK concentration data with a concentration above the LLoQ after Week 52. The overall number of participants analyzed row represents the number of participants in the PK-TP II subset who had the Ctrough data at Week 52.

Cmax was calculated by non-compartmental analysis method from the concentration-time data. All serum concentrations below the LLoQ was set to 0 in the descriptive summaries of PK parameter estimation.

Participants in the PK Set who had assessments of Cmax.

Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration at each visit was calculated as ([Result at each visit - Result at Baseline] / Result at Baseline) × 100.

The PD set was defined as all participants who received a full dose of the study drug (CT-P41 or US-licensed Prolia) at Day 1 (Week 0) and had at least 1 post-treatment PD concentration data with a concentration above the LLoQ before dosing at Week 52. The overall number of participants analyzed represents the total number of participants in PD set. The number analyzed per row represents the number of participants in the PD set who had the data at the corresponding time point.

Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration at each visit was calculated as ([Result at each visit - Result at Baseline] / Result at Baseline) × 100.

The PD-TP II subset was defined as all participants in the PD set who received 1 full dose of the study drug (CT-P41 or US-licensed Prolia) at Week 52 and had at least 1 post-treatment PD concentration data with a concentration above the LLoQ after Week 52. The overall number of participants analyzed represents the number of participants in the PD-TP II subset who had s-CTX value at baseline and Week 78.

Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration at each visit was calculated as ([Result at each visit - Result at Baseline] / Result at Baseline) × 100.

The overall number of participants analyzed represents the total number of participants in PD Set. The number analyzed per row represents the number of participants in PD set who had P1NP value at the corresponding time point.

Serum concentration below the LLoQ was set to the LLoQ. The percent change from baseline for serum concentration was calculated as ([Result at each visit - Result at Baseline] / Result at Baseline) × 100.

The overall number of participants analyzed represents the number of participants in the PD-TP II subset who had the P1NP value at baseline and Week 78.

Samples that were positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. The test outcomes for the screening assay were 'Positive' or 'Negative'. The number of patients with at least one ADA/NAb positive result after the first study drug administration of each treatment period including scheduled and unscheduled visits (Treatment Period I: Week 0 / Treatment Period II: Week 52) regardless of their ADA status at baseline were presented.

The Safety set was defined as all participants who received at least 1 dose (full or partial) of the study drug (CT-P41 or US-licensed Prolia). The overall number of participants analyzed and the number analyzed represents the total number of participants in the Safety Set.

Samples that were positive in the ADA confirmatory assay were analyzed further to conduct a NAb assessment. The test outcomes for the screening assay were 'Positive' or 'Negative'. The number of patients with at least one ADA/NAb positive result after the first study drug administration of each treatment period including scheduled and unscheduled visits (Treatment Period I: Week 0 / Treatment Period II: Week 52) regardless of their ADA status at baseline were presented.

The Safety-TP II subset was defined as all participants in the Safety set who received 1 dose (full or partial) of study drug (CT-P41 or US-licensed Prolia) at Week 52. The overall number of participants analyzed and the number analyzed represents the number of participants in the Safety-TP II subset.