Postmenopausal Osteoporosis Clinical Trial
Official title:
A Randomised, Double Blind, Multicentre Phase III Study to Assess the Efficacy and Safety of RGB-14-P Compared to Prolia® in Women With Postmenopausal Osteoporosis
Verified date | December 2023 |
Source | Gedeon Richter Plc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 473 |
Est. completion date | November 15, 2023 |
Est. primary completion date | October 2, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 60 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Medical Center Medconsult Pleven | Pleven | |
Bulgaria | DKC "Sveti Georgi" | Plovdiv | |
Bulgaria | UMHAT Kaspela | Plovdiv | |
Bulgaria | UMHAT Kaspela (Endocrinology/metabolic disease) | Plovdiv | |
Bulgaria | UMHAT Plovdiv | Plovdiv | |
Bulgaria | UMHAT Pulmed - Reumathology | Plovdiv | |
Bulgaria | Medical Center - Teodora EOOD | Ruse | |
Bulgaria | "DCC XVII-Sofia" EOOD | Sofia | |
Bulgaria | Medical Center Excelsior | Sofia | |
Bulgaria | Medical Center Hera EOOD - Rheumatology Office | Sofia | Sofia-Grad |
Czechia | FN Hradec Kralove | Hradec Králové | |
Czechia | Klatovska nemocnice, a.s. | Klatovy | |
Czechia | APAVAR Lekarna | Ostrava | Ostrava-mesto |
Czechia | Fakultni nemocnice Plzen | Plzen | |
Czechia | Affidea Praha s.r.o. | Praha 11 | |
Czechia | Revmatologicky ustav | Praha 2 | |
Czechia | Fakultni nemocnice v Motole | Praha 5 | |
Hungary | Qualiclinic Kft. | Budapest | |
Hungary | Semmelweis Egyetem | Budapest | |
Hungary | Debreceni Egyetem Klinikai Kozpont | Debrecen | Hajdú-Bihar |
Hungary | Pest Megyei Flor Ferenc Korhaz | Kistarcsa | |
Hungary | BAZM KKH EOK Szt Ferenc Tagkh | Miskolc | Borsod-Abaúj-Zemplén |
Hungary | Csongrad Megyei Dr Bugyi Istvan Korhaz | Szentes | |
Italy | IRCCS Policlinico San Matteo, Università degli studi di Pavi | Pavia | |
Italy | Azienda Ospedaliera di Perugia - Ospedale Santa Maria della | Perugia | |
Italy | Azienda Ospedaliero Universitaria Integrata Verona | Veneto | |
Poland | ClinicMed Daniluk, Nowak Sp. J | Bialystok | Podlaskie |
Poland | Komisja Bioetyczna przy OIL w Bialymstoku | Bialystok | Podlaskie |
Poland | Nasz Lekarz Osrodek Badan Klinicznych | Bialystok | Podlaskie |
Poland | Nasz Lekarz Osrodek Badan Klinicznych | Bydgoszcz | |
Poland | Centrum Medyczne Pratia Gdynia | Gdynia | |
Poland | Centrum Medyczne Pratia Katowice | Katowice | |
Poland | Barbara Rewerska Diamond Clin. | Krakow | Malopolskie |
Poland | Centrum Medyczne Plejady | Kraków | |
Poland | Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda | Lublin | Lubelskie |
Poland | Oswiecimskie Centrum Badan Klinicznych | Oswiecim | |
Poland | RCMed | Sochaczew | |
Poland | RCMed Oddzial Sochaczew | Sochaczew | |
Poland | Lubelskie Centrum Diagnostyczne | Swidnik | Lubelskie |
Poland | Centralny Szpital Kliniczny MSWiA w Warszawie | Warszawa | Mazowieckie |
Poland | Centrum Medyczne Reuma Park | Warszawa | |
Poland | Medycyna Kliniczna | Warszawa | |
Poland | RCMed Oddzial Warszawa | Warszawa | |
Spain | Complejo Hospitalario Universitario A Coruña | A Coruña | |
Spain | Hospital de La Santa Creu i Sant Pau | Barcelona | |
Spain | Centro Medico Instituto Palacios | Madrid | |
Spain | Corporacio Sanitaria Parc Tauli de Sabadell - Servicio de reumatologia | Sabadell | Barcelona |
Spain | Clinica Gaias Santiago | Santiago De Compostela | |
Spain | H. Ntra. Sra. de la Esperanza | Santiago De Compostela | A Coruña |
Ukraine | Derzhavna ustanova "Instytut herontolohii imeni D.F. Chebotarova Natsionalnoi akademii medychnykh nauk Ukrainy | Kyiv | Kyïv |
Ukraine | Medychnyi tsentr tovarystva z obmezhenoyu vidpovidalnistyu "Medbud-Klinik" | Kyiv | Kyïv |
Ukraine | Kyivska klinichna likarnia na zaliznychnomu transporti #2 filii "Tsentr okhorony zdoroviya" AT "Ukrayinska Zaliznytsia" | Kyïv | |
Ukraine | Med tsentr TOV "Tsentr simeinoi medytsyny plius" | Kyïv | |
Ukraine | Naukovo-doslidnyi instytut reabilitatsii osib z invalidnistiu (navchalno-naukovo-likuvalnyi kompleks) Vinnytskoho natsionalnoho medychnoho universytetu im. M.I. Pyrohova | Vinnytsia | Vinnyts'ka Oblast' |
Ukraine | Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova | Vinnytsia | Vinnyts'ka Oblast' |
United States | iResearch Atlanta, LLC | Decatur | Georgia |
United States | Excel Clinical Research - Internal Medicine | Las Vegas | Nevada |
United States | Miami Clinical Research | Miami | Florida |
United States | Global Health Research Center | Miami Lakes | Florida |
Lead Sponsor | Collaborator |
---|---|
Gedeon Richter Plc. |
United States, Bulgaria, Czechia, Hungary, Italy, Poland, Spain, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage change from baseline in lumbar spine bone mineral density (BMD) | Efficacy and effect similarity of RGB-14- P with US-licensed Prolia® on BMD at the lumbar spine at Week 52 will be determined in female participants with postmenopausal osteoporosis. | Baseline, Week 52 | |
Primary | Area under the effective curve after the first dose until Day 183 of percent change from baseline in serum type I collagen C-telopeptide up to month 6 (AUEC of %CfB in sCTX00-m6) until Week 26 | Similar pharmacodynamics (AUEC of %CfB in sCTX) of RGB-14-P with US-licensed Prolia® in female participants will be demonstrated with postmenopausal osteoporosis. | Baseline, until Week 26 (Predose) | |
Secondary | Percentage change from baseline in total hip BMD | Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis. | Baseline, Weeks 26, 52 and 78 | |
Secondary | Percentage change from baseline in lumbar spine BMD | Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis. | Baseline, Weeks 26 and 78 | |
Secondary | Percentage change from baseline in femoral neck BMD | Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis. | Baseline, Weeks 26, 52 and 78 | |
Secondary | Vertebral fragility fracture incidence | Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis. | Weeks 52 and 78 | |
Secondary | Non-vertebral fragility fracture incidence | Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis. | Weeks 52 and 78 | |
Secondary | Percentage change from baseline in serum procollagen type 1 N terminal propeptide (P1NP) | Additional comparative pharmacodynamic data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis. | Baseline, Weeks 4, 26, 52 and 78 | |
Secondary | Percentage change from baseline in serum type I collagen C-telopeptide (sCTX) | Additional comparative pharmacodynamic data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis. | Baseline, Weeks 4, 26, 52 and 78 | |
Secondary | Number of participants with adverse events (AEs) | The safety and tolerability of RGB-14-P with US-licensed Prolia® will be compared in female participants with postmenopausal osteoporosis will be compared. | From Screening (Weeks -5 to 0) until Week 78 | |
Secondary | Number of participants with anti-drug antibodies (ADAs) and neutralizing antibodies | The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis will be compared. | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 | |
Secondary | Titre of ADAs against RGB-14-P | The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis will be compared. | Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78 |
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