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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05087030
Other study ID # RGB 14 101
Secondary ID 2020 006017 38
Status Completed
Phase Phase 3
First received
Last updated
Start date September 21, 2021
Est. completion date November 15, 2023

Study information

Verified date December 2023
Source Gedeon Richter Plc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
RGB-14-P
Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.
Prolia®
Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Gedeon Richter Plc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Czechia,  Hungary,  Italy,  Poland,  Spain,  Ukraine, 

Outcome

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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