| Primary | Percent Change From Baseline in LS-BMD at Week 52 | Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52 | The mITT population was used for this analysis. The modified intent-to-treat (mITT) analysis set will include all randomized patients who received at least 1 dose of IMP and had at least 1 post-baseline evaluation of LS-BMD | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of change from baseline | | Baseline and week 52 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0004.76(3.82 to 5.69)
- OG0014.54(3.62 to 5.47)
|
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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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| LS means, differences and confidence intervals (CI) from the ANCOVA model with percent change from baseline to Week 52 in LS-BMD as the outcome, treatment group, region and previous use of bisphosphates as fixed effects, baseline LS-BMD and baseline weight as covariates. Missing outcomes imputed using multiple imputation methods under the MAR assumption. | | | | | Mean Difference (Net) | 0.21 | | | 2-Sided | 95 | -0.73 | 1.15 | | | | | Equivalence | Biosimilarity will be demonstrated if the 95% CI for the difference falls entirely within the equivalence margin of (-1.45, +1.45). |
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| Secondary | Percent Change From Baseline in sCTX-1 at Week 26 | Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen at week 26 | The mITT was used for this analysis. The modified intent-to-treat (mITT) analysis set includes all randomized patients who received at least 1 dose of IMP and had at least 1 post-baseline evaluation of LS-BMD | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of change from baseline | | Baseline and week 26 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Percent Change From Baseline in LS-BMD at Week 26 | Percent change from baseline in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26 | The mITT population was used in this analysis. | Posted | | Mean | Standard Deviation | percentage of change from baseline | | Baseline and week 26 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Percent Change From Baseline in Femoral Neck BMD at Week 26 | Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 26 | mITT population was used for this analysis. | Posted | | Mean | Standard Deviation | percentage of change from baseline | | Baseline, week 26 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Percent Change From Baseline in Total Hip BMD at Week 26 | Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 26 | mITT population was used for the analysis. | Posted | | Mean | Standard Deviation | percentage of change from baseline | | Baseline, week 26 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Percent Change From Baseline in sCTX-1 | Percent change from baseline in serum C-telopeptide cross-link of type 1 collagen | mITT population was used for this analysis. | Posted | | Mean | Standard Deviation | percentage of change from baseline | | Baseline through Week 52 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Percentage of Participatns With sCTX-1 Suppression at Week 4 | Proportion of patients with suppression of serum C-telopeptide cross-link of type 1 collagen at week 4 | mITT population was used. | Posted | | Number | | Percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Percent Change From Baseline in P1NP | Percent change from baseline in procollagen type 1 N propeptide (P1NP) to Week 52 | mITT population was used for this analysis. | Posted | | Mean | Standard Deviation | percentage of change from baseline | | Baseline through Week 52 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Number of Fractures up to Week 52 | Number of patients with who experienced any new fractures up to week 52. | mITT population was used. | Posted | | Number | | number participants with fractures | | Up to week 52 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Percent Change From Week 52 in LS-BMD by DXA at Week 78 | Percent change from week 52 in lumbar spine bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78 | TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD. | Posted | | Mean | Standard Deviation | percentage of change from baseline | | Week 52 through week 78 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main / PROLIA Transition Period | Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | PROLIA Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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| Secondary | Percent Change From Week 52 in Femoral Neck BMD by DXA at Week 78 | Percent change from week 52 in femoral neck bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78 | TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD. | Posted | | Mean | Standard Deviation | Percent change from week 52 | | Week 52 through week 78 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main / PROLIA Transition Period | Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | PROLIA Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
|
| Secondary | Percent Change From Week 52 in Total Hip BMD by DXA at Week 78 | Percent change from week 52 in total hip bone mineral density (LS BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 78 | TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD. | Posted | | Mean | Standard Deviation | Percent change from week 52 | | Week 52 through week 78 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main / PROLIA Transition Period | Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | PROLIA Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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| Secondary | Difference Between Percent Change From Baseline in sCTX-1 Between Week 52 and Week 78 | Difference in the percent change from baseline in serum C-telopeptide cross-link of type 1 collagen from baseline to Week 78 as compared to baseline to Week 52 | TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD. | Posted | | Mean | Standard Deviation | Percent change from baseline | | Baseline, Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main / PROLIA Transition Period | Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | PROLIA Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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| Secondary | Difference Between Percent Change From Baseline in P1NP Between Week 52 and Week 78 | The difference in the Percent change from baseline in procollagen type 1 N propeptide at Week 78 compared to Week 52. | TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, Week 52, Week 78 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main / PROLIA Transition Period | Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | PROLIA Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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| Secondary | Number of Patients With Fractures Between Week 52 and Week 78 | Number of patients experiencing new fractures between week 52 and week 78 | TmITT population was used. The transition modified intent-to-treat (TmITT) analysis set will include all patients who received the third dose of IMP and had an end-of-study evaluation of LS-BMD. | Posted | | Number | | Number participants with fractures | | Week 52 through week 78 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main / PROLIA Transition Period | Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | PROLIA Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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| Secondary | Incidence of Adverse Event | Number of patients reporting at least one treatment-emergent adverse event up to week 52 | Safety Analysis Set (SAS) was used. The safety analysis set will include all randomized patients who received at least 1 dose of IMP. | Posted | | Count of Participants | | Participants | | Up to week 52 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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| Secondary | Incidence of Adverse Events in the Transition Period | Number of patients reporting at least one treatment-emergent adverse event between weeks 52 and 78 | Transition Safety Analysis Set was used. The transition safety analysis set will include all patients who received the third dose of the IMP. | Posted | | Count of Participants | | Participants | | Week 52 through week 78 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main / PROLIA Transition Period | Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | PROLIA Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
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| Secondary | Incidence of Antidrug Antibodies (ADAs) in the Main Treatment Period | Number of patients with confirmed positive antidrug antibodies (ADAs) post-baseline through Week 52 | The Safety Analysis Set was used. The safety analysis set will include all randomized patients who received at least 1 dose of IMP. | Posted | | Count of Participants | | Participants | | Anytime Post Baseline through Week 52 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Incidence of Antidrug Antibodies (ADAs) in the Transition Period | Number of patients with confirmed positive antidrug antibodies (ADAs) at Week 65 | The Transition Safety Analysis Set was used. The transition safety analysis set will include all patients who received the third dose of the IMP. | Posted | | Count of Participants | | Participants | | Anytime in Week 52 through Week 78 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main / PROLIA Transition Period | Prolia® (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | PROLIA Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to PROLIA in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
|
| Secondary | Percent Change From Baseline in Femoral Neck BMD at Week 52 | Percent change from baseline in femoral neck bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA)at week 52 | mITT population was used for this analysis. | Posted | | Mean | Standard Deviation | Percent change from baseline | | Baseline through Week 52 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Percent Change From Baseline in Total Hip BMD at Week 52 | Percent change from baseline in total hip bone mineral density (BMD) based on centrally assessed dual energy X ray absorptiometry (DXA) at week 52 | mITT population was used for the analysis. | Posted | | Mean | Standard Deviation | Percent change from baseline | | Baseline through Week 52 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) |
| |
| Secondary | Number of TEAEs Leading to Patient Withdraw From the Study | Number of patients that withdraw or are removed from the study due to treatment emergent adverse events from both the main and transition treatment periods. | | Posted | | Count of Participants | | Participants | | Main Treatment Period = Baseline-Week 52; Transition period = Week 52-78 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG003 |
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| Secondary | Local Tolerability at Injection Site | Number of patients who report Injection Site Reactions at Day 1, Week 26, or Week 52. | | Posted | | Count of Participants | | Participants | | Main Treatment Period = Day 1 & Week 26; Transition Treatment Period = Week 52 | | | | ID | Title | Description |
|---|
| OG000 | TVB-009 Main Treatment Period | TVB-009 (denosumab) pre-filled syringe, administered at weeks 1 and 26 TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG001 | PROLIA Main Treatment Period | Prolia® (denosumab) pre-filled syringe, administered at weeks 1 and 26 Prolia®: Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG002 | TVB-009 Main / TVB-009 Transition Period | TVB-009 (denosumab) pre-filled syringe, administered at week 52 in patients that were randomized to TVB-009 in the main treatment period TVB-009: TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS) | | OG003 | PROLIA Main / PROLIA Transition Period |
|