Postmenopausal Osteoporosis
Conditions
Keywords
Biosimilars, Prolia®
Brief summary
This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.
Detailed description
This is a randomized, double-blind, multicentre, multiple fixed-dose, 2-arm parallel-group study that includes 2 periods as: 1. Main period (52 weeks), consists of Treatment Period 1 (26 weeks) and Treatment Period 2 (26 weeks). On Day 1 of Treatment Period 1, prior to dosing, participants will be randomized in a 1:1 ratio to receive either RGB-14-P or Prolia®. 2. Transition Period: consists of Treatment Period 3 (26 weeks). On Day 1 of Treatment Period 3 (Week 52), a subset of participants who received Prolia® during the Main Period will be re-randomized 1:1 to receive either a dose RGB-14-P or Prolia® in a double-blinded manner. A subset of participants continuing in the Transition Period who received RGB-14-P during the Main Period will continue to receive a dose of RGB-14- P but will also follow the randomization procedure to maintain blinding. All participants will receive the study drugs on 2 occasions (Weeks 0 and 26), on Day 1 of Treatment Periods 1 and 2. Participants continuing to the Transition Period will receive the study drugs on a third-occasion (Week 52), Day 1 of Treatment Period 3. One Treatment Period will take 6 months (26 weeks, 183 days).
Interventions
DRUGRGB-14-P
Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.
DRUGProlia®
Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.
Sponsors
Gedeon Richter Plc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
A double-blind design will be used during the main and transition periods.
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Participant is an ambulatory postmenopausal woman, diagnosed with osteoporosis, able to walk, and not bedridden * Participant has an absolute BMD consistent with T score ≤ 2.5 and ≥ 4.0 at the lumbar spine as measured by dual-energy X-ray absorptiometry (DXA) during the Screening Period and at least 2 lumbar vertebrae (from L1 to L4) must be evaluable by DXA * Participant has body weight ≥ 50 and ≤ 90 kg at the Screening Period Participants must meet the following criteria to be enrolled in the Transition Period: \- Have been enrolled, received both doses of the test drug, and completed the scheduled Main Period (up to Week 52) of the RGB-14-101 study
Exclusion criteria
* Participant has a history and/or presence of a severe or more than two moderate vertebral fractures as determined by central reading of lateral spine X-ray during the Screening Period * Participant has a history and/or presence of hip fracture * Participant has a history and/or presence of atypical femur fracture * Participant presents with an active healing fracture * Participant has a bilateral hip replacement (unilateral is allowed if the other hip is evaluable with DXA) * Participant has a vitamin D deficiency * Participant has hypocalcaemia or hypercalcemia at the Screening Period * Participant has a history and/or presence of bone metastases, renal osteodystrophy, osteomyelitis, any metabolic, endocrine or traumatic bone disease * Participant has a current uncontrolled status of hypothyroidism or hyperthyroidism * Participant has a history (within 5 years prior to Screening) and/or current hypoparathyroidism or hyperparathyroidism * Participant has malignancy within 5 years before Screening * Participant has a history and/or presence of significant cardiac disease * Participant has a known intolerance or malabsorption of calcium or vitamin D supplements * Participant shows contraindications to denosumab therapy (e.g., hypocalcaemia), or calcium or vitamin D supplementation before starting test drug administration * Participant has a latex allergy * Participant has a history and/or presence of osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures * Participant has history and/or presence of osteonecrosis of the external auditory canal * Participant requiring ongoing use of any osteoporosis treatment * Participant has previously received denosumab or biosimilar denosumab * Participant has weight or girth measurements which may preclude accurate DXA measurements * Participant has an active infection, including, but not limited to severe acute respiratory syndrome coronavirus-2, hepatis B, hepatitis C and human immunodeficiency virus infections during the Screening Period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD) | Week 52 | Percentage change from baseline in lumbar bone BMD was assessed. BMD at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). This outcome measure was assessed for main period. |
| Area Under the Effective Curve (AUEC) After the First Dose Until Day 183 of %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 26 | The AUEC of %CfB in sCTX of RGB-14-P was assessed as part of pharmacodynamics parameter with US-licensed Prolia® in female participants was demonstrated with postmenopausal osteoporosis. This outcome measure was assessed for main period only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| %CfB in Femoral Neck BMD | Weeks 26, 52 and 78 | %CfB in femoral neck BMD was assessed by DXA. |
| Number of Participants With Vertebral Fragility Fracture | Weeks 52 and 78 | Number of participants with vertebral fragility fracture was assessed. Information on vertebral fractures was centrally collected through the evaluation of lateral thoraco-lumbar spine X-ray. |
| Number of Participants With Non-vertebral Fragility Fracture | Weeks 52 and 78 | Number of participants with non-vertebral fragility fracture was assessed. Information on non-vertebral fractures was centrally collected through the evaluation of lateral thoraco-lumbar spine X-ray. |
| %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Weeks 4, 26, 52 and 78 | %CfB in serum P1NP was assessed as part of pharmacodynamics parameter with US-licensed Prolia® in female participants with postmenopausal osteoporosis. |
| %CfB in Total Hip BMD | Weeks 26, 52 and 78 | %CfB in total hip BMD was assessed. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78 | The safety and tolerability of RGB-14-P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed. |
| Number of Participants With Anti-drug Antibodies (ADAs) | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 | Number of participants with positive ADAs was assessed. |
| Number of Participants With Neutralizing Antibodies | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 | Number of participants with positive neutralizing antibodies was assessed. |
| Titre of ADAs | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 | The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed. |
| %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Weeks 4, 26, 52 and 78 | %CfB in sCTX was assessed as part of pharmacodynamics parameter with US-licensed Prolia® was assessed in female participants with postmenopausal osteoporosis. |
| %CfB in Lumbar Spine BMD | Weeks 26 and 78 | %CfB in lumbar spine BMD was assessed. |
Countries
Bulgaria, Czechia, Hungary, Italy, Poland, Spain, Ukraine, United States
Participant flow
Recruitment details
The study was conducted between 21-September-2021 (first subject first visit) to 15-November-2023 (last subject last visit).
Pre-assignment details
A total 473 participants were randomized in this study. The screening period was up to 35 days. ICF was signed prior to screening procedures. Subjects received study drug in a randomized order. All study assessments were performed as per the schedule of assessments.
Participants by arm
| Arm | Count |
|---|---|
| Main Period: RGB-14-P Participants received RGB-14-P as subcutaneous (SC) injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26). | 242 |
| Main Period: Prolia® Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26). | 231 |
| Total | 473 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Main Period (Week 0 to Week 52) | Adverse Event | 2 | 2 | 0 | 0 | 0 |
| Main Period (Week 0 to Week 52) | Death | 0 | 1 | 0 | 0 | 0 |
| Main Period (Week 0 to Week 52) | Exclusion criteria met | 1 | 0 | 0 | 0 | 0 |
| Main Period (Week 0 to Week 52) | Lost to Follow-up | 3 | 0 | 0 | 0 | 0 |
| Main Period (Week 0 to Week 52) | Other | 1 | 2 | 0 | 0 | 0 |
| Main Period (Week 0 to Week 52) | Protocol Deviation | 1 | 0 | 0 | 0 | 0 |
| Main Period (Week 0 to Week 52) | Study Objective Confounded By Monoclonal Gammopathy | 1 | 0 | 0 | 0 | 0 |
| Main Period (Week 0 to Week 52) | Subject's Personal Reason | 0 | 2 | 0 | 0 | 0 |
| Main Period (Week 0 to Week 52) | Withdrawal by Subject | 8 | 13 | 0 | 0 | 0 |
| Transition Period (Week 52 to Week 78) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Main Period: Prolia® | Total | Main Period: RGB-14-P |
|---|---|---|---|
| Age, Continuous | 66.8 Years STANDARD_DEVIATION 4.91 | 66.7 Years STANDARD_DEVIATION 5.06 | 66.7 Years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 40 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 209 Participants | 432 Participants | 223 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 229 Participants | 470 Participants | 241 Participants |
| Sex: Female, Male Female | 231 Participants | 473 Participants | 242 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 242 | 1 / 231 | 0 / 63 | 0 / 62 | 0 / 63 |
| other Total, other adverse events | 100 / 242 | 85 / 231 | 4 / 63 | 3 / 62 | 6 / 63 |
| serious Total, serious adverse events | 7 / 242 | 16 / 231 | 0 / 63 | 0 / 62 | 0 / 63 |
Outcome results
Primary
Area Under the Effective Curve (AUEC) After the First Dose Until Day 183 of %CfB in Serum Type I Collagen C-telopeptide (sCTX)
The AUEC of %CfB in sCTX of RGB-14-P was assessed as part of pharmacodynamics parameter with US-licensed Prolia® in female participants was demonstrated with postmenopausal osteoporosis. This outcome measure was assessed for main period only.
Time frame: Week 26
Population: The pharmacodynamic analysis set included all participants in the safety population with at least one evaluable pharmacodynamic parameter (%CfB and AUEC) and not had any protocol deviations that have a relevant impact on sCTX or serum Prokollagen Typ 1 N-terminales Propeptid (P1NP) results included in the pharmacodynamic parameter calculation. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Main Period: RGB-14-P | Area Under the Effective Curve (AUEC) After the First Dose Until Day 183 of %CfB in Serum Type I Collagen C-telopeptide (sCTX) | 14609.67 mg/dL*day | Standard Deviation 3142.086 |
| Main Period: Prolia® | Area Under the Effective Curve (AUEC) After the First Dose Until Day 183 of %CfB in Serum Type I Collagen C-telopeptide (sCTX) | 14134.86 mg/dL*day | Standard Deviation 7331.714 |
Comparison: Comparison between Study Treatment Groupsp-value: 0.49495% CI: [0.978, 1.046]ANCOVA
Primary
Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD)
Percentage change from baseline in lumbar bone BMD was assessed. BMD at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). This outcome measure was assessed for main period.
Time frame: Week 52
Population: The Full analysis set (FAS) included all participants to whom the investigational medicinal product (IMP) has been randomized. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Main Period: RGB-14-P | Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD) | 5.68 Percentage change from baseline | Standard Deviation 3.535 |
| Main Period: Prolia® | Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD) | 5.19 Percentage change from baseline | Standard Deviation 4.118 |
90% CI: [-0.465, 0.826]ANCOVA
90% CI: [-0.099, 1.191]ANCOVA
Secondary
%CfB in Femoral Neck BMD
%CfB in femoral neck BMD was assessed by DXA.
Time frame: Weeks 26, 52 and 78
Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Period: RGB-14-P | %CfB in Femoral Neck BMD | Week 26 | 1.88 Percentage change from baseline | Standard Deviation 3.04 |
| Main Period: RGB-14-P | %CfB in Femoral Neck BMD | Week 52 | 2.42 Percentage change from baseline | Standard Deviation 3.687 |
| Main Period: Prolia® | %CfB in Femoral Neck BMD | Week 52 | 2.64 Percentage change from baseline | Standard Deviation 3.751 |
| Main Period: Prolia® | %CfB in Femoral Neck BMD | Week 26 | 1.94 Percentage change from baseline | Standard Deviation 3.61 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Femoral Neck BMD | Week 78 | 3.08 Percentage change from baseline | Standard Deviation 4.259 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Femoral Neck BMD | Week 26 | 1.60 Percentage change from baseline | Standard Deviation 2.833 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Femoral Neck BMD | Week 52 | 1.95 Percentage change from baseline | Standard Deviation 3.621 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Femoral Neck BMD | Week 78 | 3.06 Percentage change from baseline | Standard Deviation 3.337 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Femoral Neck BMD | Week 52 | 2.60 Percentage change from baseline | Standard Deviation 3.127 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Femoral Neck BMD | Week 26 | 2.21 Percentage change from baseline | Standard Deviation 3.296 |
| Transition Period: Prolia® to Prolia® | %CfB in Femoral Neck BMD | Week 78 | 4.04 Percentage change from baseline | Standard Deviation 4.764 |
| Transition Period: Prolia® to Prolia® | %CfB in Femoral Neck BMD | Week 52 | 3.24 Percentage change from baseline | Standard Deviation 4.549 |
| Transition Period: Prolia® to Prolia® | %CfB in Femoral Neck BMD | Week 26 | 2.35 Percentage change from baseline | Standard Deviation 4.057 |
Secondary
%CfB in Lumbar Spine BMD
%CfB in lumbar spine BMD was assessed.
Time frame: Weeks 26 and 78
Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Period: RGB-14-P | %CfB in Lumbar Spine BMD | Week 26 | 3.56 Percentage change from baseline | Standard Deviation 3.747 |
| Main Period: Prolia® | %CfB in Lumbar Spine BMD | Week 26 | 3.45 Percentage change from baseline | Standard Deviation 4.227 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Lumbar Spine BMD | Week 26 | 3.98 Percentage change from baseline | Standard Deviation 3.185 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Lumbar Spine BMD | Week 78 | 7.03 Percentage change from baseline | Standard Deviation 3.828 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Lumbar Spine BMD | Week 78 | 7.06 Percentage change from baseline | Standard Deviation 4.327 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Lumbar Spine BMD | Week 26 | 3.39 Percentage change from baseline | Standard Deviation 3.848 |
| Transition Period: Prolia® to Prolia® | %CfB in Lumbar Spine BMD | Week 78 | 7.09 Percentage change from baseline | Standard Deviation 4.24 |
| Transition Period: Prolia® to Prolia® | %CfB in Lumbar Spine BMD | Week 26 | 3.68 Percentage change from baseline | Standard Deviation 4.979 |
Comparison: Week 26p-value: 0.92995% CI: [-0.703, 0.769]mixed model for repeated measures
Secondary
%CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP)
%CfB in serum P1NP was assessed as part of pharmacodynamics parameter with US-licensed Prolia® in female participants with postmenopausal osteoporosis.
Time frame: Weeks 4, 26, 52 and 78
Population: PD analysis set included all participants in safety population with at least one evaluable PD parameter (%CfB and AUEC) and not had any protocol deviations that have a relevant impact on sCTX or serum P1NP results included in PD parameter calculation. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Period: RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 52 | 65.04 Percentage change from baseline | Standard Deviation 19.131 |
| Main Period: RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 4 | 22.10 Percentage change from baseline | Standard Deviation 14.905 |
| Main Period: RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 26 | 65.92 Percentage change from baseline | Standard Deviation 17.828 |
| Main Period: Prolia® | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 26 | 62.89 Percentage change from baseline | Standard Deviation 29.294 |
| Main Period: Prolia® | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 4 | 20.22 Percentage change from baseline | Standard Deviation 15.091 |
| Main Period: Prolia® | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 52 | 63.82 Percentage change from baseline | Standard Deviation 21.712 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 78 | 64.12 Percentage change from baseline | Standard Deviation 18.845 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 26 | 68.42 Percentage change from baseline | Standard Deviation 11.693 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 52 | 64.86 Percentage change from baseline | Standard Deviation 16.902 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 4 | 19.85 Percentage change from baseline | Standard Deviation 13.939 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 52 | 66.05 Percentage change from baseline | Standard Deviation 20.428 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 78 | 66.91 Percentage change from baseline | Standard Deviation 16.816 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 26 | 63.41 Percentage change from baseline | Standard Deviation 42.677 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 4 | 18.45 Percentage change from baseline | Standard Deviation 15.835 |
| Transition Period: Prolia® to Prolia® | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 78 | 63.08 Percentage change from baseline | Standard Deviation 21.364 |
| Transition Period: Prolia® to Prolia® | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 4 | 17.31 Percentage change from baseline | Standard Deviation 15.524 |
| Transition Period: Prolia® to Prolia® | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 26 | 66.08 Percentage change from baseline | Standard Deviation 16.098 |
| Transition Period: Prolia® to Prolia® | %CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP) | Week 52 | 65.89 Percentage change from baseline | Standard Deviation 17.651 |
Secondary
%CfB in Serum Type I Collagen C-telopeptide (sCTX)
%CfB in sCTX was assessed as part of pharmacodynamics parameter with US-licensed Prolia® was assessed in female participants with postmenopausal osteoporosis.
Time frame: Weeks 4, 26, 52 and 78
Population: PD analysis set included all participants in safety population with at least one evaluable PD parameter (%CfB and AUEC) and not had any protocol deviations that have a relevant impact on sCTX or serum P1NP results included in PD parameter calculation. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Period: RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 52 | 62.90 Percentage change from baseline | Standard Deviation 28.995 |
| Main Period: RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 4 | 85.87 Percentage change from baseline | Standard Deviation 9.567 |
| Main Period: RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 26 | 69.74 Percentage change from baseline | Standard Deviation 23.212 |
| Main Period: Prolia® | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 26 | 61.51 Percentage change from baseline | Standard Deviation 83.764 |
| Main Period: Prolia® | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 4 | 85.38 Percentage change from baseline | Standard Deviation 15.501 |
| Main Period: Prolia® | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 52 | 58.26 Percentage change from baseline | Standard Deviation 63.927 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 78 | 58.70 Percentage change from baseline | Standard Deviation 34.117 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 26 | 67.29 Percentage change from baseline | Standard Deviation 23.572 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 52 | 60.41 Percentage change from baseline | Standard Deviation 31.958 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 4 | 84.96 Percentage change from baseline | Standard Deviation 11.206 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 52 | 53.89 Percentage change from baseline | Standard Deviation 94.853 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 78 | 53.32 Percentage change from baseline | Standard Deviation 42.855 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 26 | 53.23 Percentage change from baseline | Standard Deviation 147.679 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 4 | 84.71 Percentage change from baseline | Standard Deviation 23.071 |
| Transition Period: Prolia® to Prolia® | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 78 | 57.38 Percentage change from baseline | Standard Deviation 30.562 |
| Transition Period: Prolia® to Prolia® | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 4 | 88.08 Percentage change from baseline | Standard Deviation 5.832 |
| Transition Period: Prolia® to Prolia® | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 26 | 71.27 Percentage change from baseline | Standard Deviation 17.483 |
| Transition Period: Prolia® to Prolia® | %CfB in Serum Type I Collagen C-telopeptide (sCTX) | Week 52 | 66.79 Percentage change from baseline | Standard Deviation 24.151 |
Secondary
%CfB in Total Hip BMD
%CfB in total hip BMD was assessed.
Time frame: Weeks 26, 52 and 78
Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies participants with available data that were analyzed for specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Period: RGB-14-P | %CfB in Total Hip BMD | Week 26 | 2.42 Percentage change from baseline | Standard Deviation 2.659 |
| Main Period: RGB-14-P | %CfB in Total Hip BMD | Week 52 | 3.42 Percentage change from baseline | Standard Deviation 2.916 |
| Main Period: Prolia® | %CfB in Total Hip BMD | Week 52 | 3.49 Percentage change from baseline | Standard Deviation 2.872 |
| Main Period: Prolia® | %CfB in Total Hip BMD | Week 26 | 2.69 Percentage change from baseline | Standard Deviation 2.519 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Total Hip BMD | Week 78 | 4.24 Percentage change from baseline | Standard Deviation 3.381 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Total Hip BMD | Week 26 | 2.46 Percentage change from baseline | Standard Deviation 2.712 |
| Transition Period: RGB-14-P to RGB-14-P | %CfB in Total Hip BMD | Week 52 | 3.03 Percentage change from baseline | Standard Deviation 3.103 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Total Hip BMD | Week 78 | 4.12 Percentage change from baseline | Standard Deviation 3.128 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Total Hip BMD | Week 52 | 3.36 Percentage change from baseline | Standard Deviation 2.696 |
| Transition Period: Prolia® to RGB-14-P | %CfB in Total Hip BMD | Week 26 | 2.81 Percentage change from baseline | Standard Deviation 2.607 |
| Transition Period: Prolia® to Prolia® | %CfB in Total Hip BMD | Week 78 | 4.95 Percentage change from baseline | Standard Deviation 3.849 |
| Transition Period: Prolia® to Prolia® | %CfB in Total Hip BMD | Week 52 | 4.21 Percentage change from baseline | Standard Deviation 3.452 |
| Transition Period: Prolia® to Prolia® | %CfB in Total Hip BMD | Week 26 | 3.35 Percentage change from baseline | Standard Deviation 2.559 |
Comparison: at Week 26p-value: 0.19995% CI: [-0.792, 0.165]Mixed model repeated measures
Comparison: At Week 52p-value: 0.54395% CI: [-0.68, 0.358]mixed model repeated measures
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of RGB-14-P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed.
Time frame: Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Population: Safety analysis set included all participants who received at least one full or partial dose of IMP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to discontinuation of IMP | 1 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE | 9 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs severe or worse severity | 1 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE severe or worse severity | 2 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fatal serious TEAEs | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs | 1 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE | 36 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions severe or worse severity | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE severe or worse severity | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE severe or worse severity | 1 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs | 158 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs | 7 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE severe or worse severity | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs severe or worse severity | 5 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any non-serious TEAEs | 158 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE severe or worse severity | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs leading to participant discontinuation | 2 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions of CTCAE grade ≥ 3 | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to subject discontinuation | 2 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs severe or worse severity | 8 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to participant discontinuation | 1 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAE leading to death | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to discontinuation of IMP | 2 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 161 Participants |
| Main Period: RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE leading to death | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs severe or worse severity | 9 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to discontinuation of IMP | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions severe or worse severity | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Deaths | 1 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs severe or worse severity | 9 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 158 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE | 18 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fatal serious TEAEs | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs severe or worse severity | 1 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to subject discontinuation | 3 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE severe or worse severity | 1 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAE leading to death | 1 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs | 1 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any non-serious TEAEs | 149 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions of CTCAE grade ≥ 3 | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE | 32 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE severe or worse severity | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE severe or worse severity | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions | 2 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to discontinuation of IMP | 2 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE severe or worse severity | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs leading to participant discontinuation | 3 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE leading to death | 1 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs | 16 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs | 152 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE severe or worse severity | 0 Participants |
| Main Period: Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to participant discontinuation | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to discontinuation of IMP | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs | 30 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs severe or worse severity | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE | 2 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE severe or worse severity | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs severe or worse severity | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any non-serious TEAEs | 30 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs leading to participant discontinuation | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to subject discontinuation | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to participant discontinuation | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to discontinuation of IMP | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE | 4 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE severe or worse severity | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs severe or worse severity | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE leading to death | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAE leading to death | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE severe or worse severity | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE severe or worse severity | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE severe or worse severity | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fatal serious TEAEs | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions of CTCAE grade ≥ 3 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions severe or worse severity | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE leading to death | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAE leading to death | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs leading to participant discontinuation | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs | 25 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to discontinuation of IMP | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fatal serious TEAEs | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE | 5 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any non-serious TEAEs | 25 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions severe or worse severity | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to subject discontinuation | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to participant discontinuation | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE | 3 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs severe or worse severity | 1 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs severe or worse severity | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs severe or worse severity | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions of CTCAE grade ≥ 3 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to discontinuation of IMP | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions | 3 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Deaths | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE leading to death | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to participant discontinuation | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fatal serious TEAEs | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAE leading to death | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to subject discontinuation | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs | 25 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions | 1 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs leading to participant discontinuation | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any non-serious TEAEs | 25 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs severe or worse severity | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious TEAEs | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions of CTCAE grade ≥ 3 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related fracture TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AE | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE | 1 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related serious fracture TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE severe or worse severity | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs severe or worse severity | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any fracture TEAE | 1 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any serious fracture TEAEs severe or worse severity | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any treatment related TEAE leading to discontinuation of IMP | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any injection site reactions severe or worse severity | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any TEAEs leading to discontinuation of IMP | 0 Participants |
Secondary
Number of Participants With Anti-drug Antibodies (ADAs)
Number of participants with positive ADAs was assessed.
Time frame: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Population: Immunogenicity analysis set included all participants in the safety population who had the pre-dose immunogenicity result and at least one available post-baseline immunogenicity assessment. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Period: RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 52 | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 2 | 2 Participants |
| Main Period: RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 26 | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 0 | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 28 | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 4 | 0 Participants |
| Main Period: RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 30 | 0 Participants |
| Main Period: Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 4 | 0 Participants |
| Main Period: Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 30 | 1 Participants |
| Main Period: Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 2 | 0 Participants |
| Main Period: Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 26 | 0 Participants |
| Main Period: Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 52 | 0 Participants |
| Main Period: Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 0 | 1 Participants |
| Main Period: Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 28 | 1 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 52 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 54 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 2 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 78 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 56 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 4 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 0 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 26 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 28 | 0 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 30 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 28 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 26 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 4 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 78 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 52 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 30 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 2 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 56 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 0 | 0 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Anti-drug Antibodies (ADAs) | Week 54 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 78 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 0 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 2 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 4 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 26 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 28 | 1 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 30 | 1 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 52 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 54 | 1 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Anti-drug Antibodies (ADAs) | Week 56 | 1 Participants |
Secondary
Number of Participants With Neutralizing Antibodies
Number of participants with positive neutralizing antibodies was assessed.
Time frame: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Population: Immunogenicity analysis set included all participants in the safety population who had the pre-dose immunogenicity result and at least one available post-baseline immunogenicity assessment. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Period: RGB-14-P | Number of Participants With Neutralizing Antibodies | Week 2 | 1 Participants |
| Main Period: Prolia® | Number of Participants With Neutralizing Antibodies | Week 28 | 1 Participants |
| Main Period: Prolia® | Number of Participants With Neutralizing Antibodies | Week 0 | 0 Participants |
| Main Period: Prolia® | Number of Participants With Neutralizing Antibodies | Week 30 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Neutralizing Antibodies | Week 56 | 1 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Neutralizing Antibodies | Week 30 | 0 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Neutralizing Antibodies | Week 54 | 1 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Neutralizing Antibodies | Week 28 | 1 Participants |
Secondary
Number of Participants With Non-vertebral Fragility Fracture
Number of participants with non-vertebral fragility fracture was assessed. Information on non-vertebral fractures was centrally collected through the evaluation of lateral thoraco-lumbar spine X-ray.
Time frame: Weeks 52 and 78
Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Period: RGB-14-P | Number of Participants With Non-vertebral Fragility Fracture | Week 52 | 4 Participants |
| Main Period: Prolia® | Number of Participants With Non-vertebral Fragility Fracture | Week 52 | 10 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Non-vertebral Fragility Fracture | Week 78 | 2 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Non-vertebral Fragility Fracture | Week 78 | 5 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Non-vertebral Fragility Fracture | Week 78 | 3 Participants |
Secondary
Number of Participants With Vertebral Fragility Fracture
Number of participants with vertebral fragility fracture was assessed. Information on vertebral fractures was centrally collected through the evaluation of lateral thoraco-lumbar spine X-ray.
Time frame: Weeks 52 and 78
Population: The FAS included all participants to whom the IMP has been randomized. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Period: RGB-14-P | Number of Participants With Vertebral Fragility Fracture | Week 52 | 4 Participants |
| Main Period: Prolia® | Number of Participants With Vertebral Fragility Fracture | Week 52 | 8 Participants |
| Transition Period: RGB-14-P to RGB-14-P | Number of Participants With Vertebral Fragility Fracture | Week 78 | 3 Participants |
| Transition Period: Prolia® to RGB-14-P | Number of Participants With Vertebral Fragility Fracture | Week 78 | 4 Participants |
| Transition Period: Prolia® to Prolia® | Number of Participants With Vertebral Fragility Fracture | Week 78 | 2 Participants |
Secondary
Titre of ADAs
The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed.
Time frame: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Population: Immunogenicity analysis set included all participants in the safety population who had the pre-dose immunogenicity result and at least one available post-baseline immunogenicity assessment. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for specific timepoint for that outcome measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Period: RGB-14-P | Titre of ADAs | Week 0 | NA Titre |
| Main Period: RGB-14-P | Titre of ADAs | Week 52 | NA Titre |
| Main Period: RGB-14-P | Titre of ADAs | Week 30 | NA Titre |
| Main Period: RGB-14-P | Titre of ADAs | Week 28 | NA Titre |
| Main Period: RGB-14-P | Titre of ADAs | Week 26 | NA Titre |
| Main Period: RGB-14-P | Titre of ADAs | Week 4 | NA Titre |
| Main Period: RGB-14-P | Titre of ADAs | Week 2 | 761.0 Titre |
| Main Period: Prolia® | Titre of ADAs | Week 52 | NA Titre |
| Main Period: Prolia® | Titre of ADAs | Week 0 | 302.0 Titre |
| Main Period: Prolia® | Titre of ADAs | Week 2 | NA Titre |
| Main Period: Prolia® | Titre of ADAs | Week 4 | NA Titre |
| Main Period: Prolia® | Titre of ADAs | Week 26 | NA Titre |
| Main Period: Prolia® | Titre of ADAs | Week 28 | 172.0 Titre |
| Main Period: Prolia® | Titre of ADAs | Week 30 | 211.0 Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 0 | NA Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 30 | NA Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 2 | NA Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 56 | NA Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 4 | NA Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 26 | NA Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 28 | NA Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 54 | NA Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 78 | NA Titre |
| Transition Period: RGB-14-P to RGB-14-P | Titre of ADAs | Week 52 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 26 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 0 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 4 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 56 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 28 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 54 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 2 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 78 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 52 | NA Titre |
| Transition Period: Prolia® to RGB-14-P | Titre of ADAs | Week 30 | NA Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 78 | NA Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 4 | NA Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 54 | 224.0 Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 30 | 211.0 Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 26 | NA Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 52 | NA Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 56 | 152.0 Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 0 | NA Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 28 | 172.0 Titre |
| Transition Period: Prolia® to Prolia® | Titre of ADAs | Week 2 | NA Titre |