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| ID | Type | Description | Link |
|---|---|---|---|
| 2020 006017 38 | EudraCT Number |
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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.
This is a randomized, double-blind, multicentre, multiple fixed-dose, 2-arm parallel-group study that includes 2 periods as:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RGB-14-P (Main period) | Experimental | Randomized participants will receive subcutaneous (SC) injection of RGB-14-P, on Day 1 of Treatment periods 1 and 2. |
|
| Prolia® (Main period) | Active Comparator | Randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment periods 1 and 2. |
|
| RGB-14-P (Transition period) | Experimental | Re-randomized participants will receive SC injection of RGB-14-P, on Day 1 of Treatment period 3. |
|
| Prolia® (Transition period) | Active Comparator | Re-randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment period 3. |
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| RGB-14-P (Continued till transition period) | Experimental | Randomized participants will continue to receive SC injection of RGB-14-P from the main period till Day 1 of Treatment period 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGB-14-P | Drug | Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 52 |
| 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. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| %CfB in Total Hip BMD | %CfB in total hip BMD was assessed. | Weeks 26, 52 and 78 |
| %CfB in Lumbar Spine BMD | %CfB in lumbar spine BMD was assessed. |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Clinical Research | Miami | Florida | 33155 | United States | ||
| Global Health Research Center |
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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.
The study was conducted between 21-September-2021 (first subject first visit) to 15-November-2023 (last subject last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Main Period: Prolia® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Period (Week 0 to Week 52) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2023 | Sep 26, 2024 |
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A double-blind design will be used during the main and transition periods.
| Prolia® | Drug | Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned. |
|
| Weeks 26 and 78 |
| %CfB in Femoral Neck BMD | %CfB in femoral neck BMD was assessed by DXA. | Weeks 26, 52 and 78 |
| 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. | Weeks 52 and 78 |
| 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. | Weeks 52 and 78 |
| %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. | Weeks 4, 26, 52 and 78 |
| %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. | Weeks 4, 26, 52 and 78 |
| 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. | Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78 |
| Number of Participants With Anti-drug Antibodies (ADAs) | Number of participants with positive ADAs was assessed. | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 |
| Number of Participants With Neutralizing Antibodies | Number of participants with positive neutralizing antibodies was assessed. | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 |
| Titre of ADAs | The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed. | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 |
| Miami Lakes |
| Florida |
| 33016 |
| United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Excel Clinical Research - Internal Medicine | Las Vegas | Nevada | 89109 | United States |
| Medical Center Hera EOOD - Rheumatology Office | Sofia | Sofia-Grad | 1510 | Bulgaria |
| Medical Center Medconsult Pleven | Pleven | 5803 | Bulgaria |
| UMHAT Kaspela | Plovdiv | 4001 | Bulgaria |
| DKC "Sveti Georgi" | Plovdiv | 4002 | Bulgaria |
| UMHAT Kaspela (Endocrinology/metabolic disease) | Plovdiv | 4002 | Bulgaria |
| UMHAT Pulmed - Reumathology | Plovdiv | 4002 | Bulgaria |
| UMHAT Plovdiv | Plovdiv | Bulgaria |
| Medical Center - Teodora EOOD | Rousse | Bulgaria |
| Medical Center Excelsior | Sofia | 1407 | Bulgaria |
| "DCC XVII-Sofia" EOOD | Sofia | 1505 | Bulgaria |
| APAVAR Lekarna | Ostrava | Ostrava-město | 702 00 | Czechia |
| FN Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Klatovska nemocnice, a.s. | Klatovy | 339 01 | Czechia |
| Fakultni nemocnice Plzen | Pilsen | Czechia |
| Revmatologicky ustav | Prague | 128 50 | Czechia |
| Affidea Praha s.r.o. | Prague | 148 00 | Czechia |
| Fakultni nemocnice v Motole | Prague | 305 99 | Czechia |
| BAZM KKH EOK Szt Ferenc Tagkh | Miskolc | Borsod-Abauj Zemplen county | 3529 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | Hajdú-Bihar | 4032 | Hungary |
| Qualiclinic Kft. | Budapest | 1036 | Hungary |
| Semmelweis Egyetem | Budapest | Hungary |
| Pest Megyei Flor Ferenc Korhaz | Kistarcsa | 2143 | Hungary |
| Csongrad Megyei Dr Bugyi Istvan Korhaz | Szentes | 6600 | Hungary |
| IRCCS Policlinico San Matteo, Università degli studi di Pavi | Pavia | 27100 | Italy |
| Azienda Ospedaliera di Perugia - Ospedale Santa Maria della | Perugia | 06125 | Italy |
| Azienda Ospedaliero Universitaria Integrata Verona | Veneto | 37126 | Italy |
| Barbara Rewerska Diamond Clin. | Krakow | Lesser Poland Voivodeship | 31-559 | Poland |
| Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda | Lublin | Lublin Voivodeship | 20-607 | Poland |
| Lubelskie Centrum Diagnostyczne | Åšwidnik | Lublin Voivodeship | 21-040 | Poland |
| Centralny Szpital Kliniczny MSWiA w Warszawie | Warsaw | Masovian Voivodeship | 02-507 | Poland |
| Komisja Bioetyczna przy OIL w Bialymstoku | Bialystok | Podlaskie Voivodeship | 15-082 | Poland |
| Nasz Lekarz Osrodek Badan Klinicznych | Bialystok | Podlaskie Voivodeship | 15-082 | Poland |
| ClinicMed Daniluk, Nowak Sp. J | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Nasz Lekarz Osrodek Badan Klinicznych | Bydgoszcz | 85-065 | Poland |
| Centrum Medyczne Pratia Gdynia | Gdynia | 81-338 | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | 40-081 | Poland |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| Oswiecimskie Centrum Badan Klinicznych | Oświęcim | 32-600 | Poland |
| RCMed Oddzial Sochaczew | Sochaczew | 96-500 | Poland |
| RCMed | Sochaczew | 96-500 | Poland |
| Medycyna Kliniczna | Warsaw | 00-874 | Poland |
| RCMed Oddział Warszawa | Warsaw | 00-892 | Poland |
| Centrum Medyczne Reuma Park | Warsaw | 02-691 | Poland |
| H. Ntra. Sra. de la Esperanza | Santiago de Compostela | A Coruña | 15705 | Spain |
| Corporacio Sanitaria Parc Tauli de Sabadell - Servicio de reumatologia | Sabadell | Barcelona | 08208 | Spain |
| Complejo Hospitalario Universitario A Coruña | A Coruña | 15006 | Spain |
| Hospital de La Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Centro Medico Instituto Palacios | Madrid | 28009 | Spain |
| Clinica Gaias Santiago | Santiago de Compostela | 15703 | Spain |
| Medychnyi tsentr tovarystva z obmezhenoyu vidpovidalnistyu "Medbud-Klinik" | Kyiv | Kyïv | 0 3037 | Ukraine |
| Derzhavna ustanova "Instytut herontolohii imeni D.F. Chebotarova Natsionalnoi akademii medychnykh nauk Ukrainy | Kyiv | Kyïv | 04114 | Ukraine |
| Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova | Vinnytsia | Vinnytsia Oblast | 21018 | Ukraine |
| Naukovo-doslidnyi instytut reabilitatsii osib z invalidnistiu (navchalno-naukovo-likuvalnyi kompleks) Vinnytskoho natsionalnoho medychnoho universytetu im. M.I. Pyrohova | Vinnytsia | Vinnytsia Oblast | 21029 | Ukraine |
| Kyivska klinichna likarnia na zaliznychnomu transporti #2 filii "Tsentr okhorony zdoroviya" AT "Ukrayinska Zaliznytsia" | Kyiv | 03049 | Ukraine |
| Med tsentr TOV "Tsentr simeinoi medytsyny plius" | Kyiv | 04210 | Ukraine |
Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26).
| FG002 | Transition Period: RGB-14-P to RGB-14-P | Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| FG003 | Transition Period: Prolia® to RGB-14-P | Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| FG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
| COMPLETED |
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| NOT COMPLETED |
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| Transition Period (Week 52 to Week 78) |
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|
The full analysis set (FAS) comprised all participants to whom the investigational medicinal product (IMP) has been randomized.
Main period.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Main Period: Prolia® | Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Percentage change from baseline | Week 52 |
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| 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. | 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. | Posted | Mean | Standard Deviation | mg/dL*day | Week 26 |
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| Secondary | %CfB in Total Hip BMD | %CfB in total hip BMD was assessed. | 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. | Posted | Mean | Standard Deviation | Percentage change from baseline | Weeks 26, 52 and 78 |
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| Secondary | %CfB in Lumbar Spine BMD | %CfB in lumbar spine BMD was assessed. | 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. | Posted | Mean | Standard Deviation | Percentage change from baseline | Weeks 26 and 78 |
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| Secondary | %CfB in Femoral Neck BMD | %CfB in femoral neck BMD was assessed by DXA. | 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. | Posted | Mean | Standard Deviation | Percentage change from baseline | Weeks 26, 52 and 78 |
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| 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. | 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. | Posted | Count of Participants | Participants | Weeks 52 and 78 |
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| 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. | 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. | Posted | Count of Participants | Participants | Weeks 52 and 78 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Percentage change from baseline | Weeks 4, 26, 52 and 78 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Percentage change from baseline | Weeks 4, 26, 52 and 78 |
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| 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. | Safety analysis set included all participants who received at least one full or partial dose of IMP. | Posted | Count of Participants | Participants | Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78 |
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| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) | Number of participants with positive ADAs was assessed. | 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. | Posted | Count of Participants | Participants | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 |
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| Secondary | Number of Participants With Neutralizing Antibodies | Number of participants with positive neutralizing antibodies was assessed. | 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. | Posted | Count of Participants | Participants | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 |
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| Secondary | Titre of ADAs | The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed. | 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. | Posted | Median | Full Range | Titre | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 |
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Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Safety analysis set included all participants who received at least one full or partial dose of IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 242 | 7 | 242 | 100 | 242 |
| EG001 | Main Period: Prolia® | Participants received Prolia® as SC injection on Day 1 of Treatment Period 1 (Week 0) and Treatment Period 2 (Week 26). | 1 | 231 | 16 | 231 | 85 | 231 |
| EG002 | Transition Period: RGB-14-P to RGB-14-P | Participants who received RGB-14-P during the main period were re-randomized to receive RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). | 0 | 63 | 0 | 63 | 4 | 63 |
| EG003 | Transition Period: Prolia® to RGB-14-P | Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). | 0 | 62 | 0 | 62 | 3 | 62 |
| EG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). | 0 | 63 | 0 | 63 | 6 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA version 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Follicular lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 26.0 | Systematic Assessment |
| |
| Lumbosacral radiculopathy | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Endometrial disorder | Reproductive system and breast disorders | MedDRA version 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
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No unpublished information may be disclosed without prior written approval from sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Scientific Service | Gedeon Richter Plc. | +36 1 505 70 32 | medinfo@richter.hu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2023 | Sep 26, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ANCOVA |
| Estimated Difference |
| 0.55 |
| 2-Sided |
| 90 |
| -0.099 |
| 1.191 |
| Superiority |
Non-Superiority Test |
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
|
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
|
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
| Transition Period: Prolia® to RGB-14-P |
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
| Transition Period: Prolia® to RGB-14-P |
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
| OG003 | Transition Period: Prolia® to RGB-14-P | Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
| OG003 | Transition Period: Prolia® to RGB-14-P | Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
| Transition Period: Prolia® to RGB-14-P |
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
| OG003 |
| Transition Period: Prolia® to RGB-14-P |
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
|
|
| OG003 |
| Transition Period: Prolia® to RGB-14-P |
Participants who received Prolia® during the main period were re-randomized and received RGB-14-P as SC injection on Day 1 of Treatment period 3 (Week 52). |
| OG004 | Transition Period: Prolia® to Prolia® | Participants who received Prolia® during the main period were re-randomized and received Prolia® as SC injection on Day 1 of Treatment period 3 (Week 52). |
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