Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis

PHASE3CompletedINTERVENTIONAL
Enrollment

473

Participants

Timeline

Start Date

September 21, 2021

Primary Completion Date

October 2, 2023

Study Completion Date

November 15, 2023

Conditions
Postmenopausal Osteoporosis
Interventions
DRUG

RGB-14-P

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

DRUG

Prolia®

Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.

Trial Locations (59)

1036

Qualiclinic Kft., Budapest

1407

Medical Center Excelsior, Sofia

1505

"DCC XVII-Sofia EOOD", Sofia

1510

Medical Center Hera EOOD - Rheumatology Office, Sofia

2143

Pest Megyei Flor Ferenc Korhaz, Kistarcsa

3529

BAZM KKH EOK Szt Ferenc Tagkh, Miskolc

4001

UMHAT Kaspela, Plovdiv

4002

"DKC Sveti Georgi", Plovdiv

UMHAT Kaspela (Endocrinology/metabolic disease), Plovdiv

UMHAT Pulmed - Reumathology, Plovdiv

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

5803

Medical Center Medconsult Pleven, Pleven

6600

Csongrad Megyei Dr Bugyi Istvan Korhaz, Szentes

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

15703

Clinica Gaias Santiago, Santiago de Compostela

15705

H. Ntra. Sra. de la Esperanza, Santiago de Compostela

21018

Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova, Vinnytsia

21029

Naukovo-doslidnyi instytut reabilitatsii osib z invalidnistiu (navchalno-naukovo-likuvalnyi kompleks) Vinnytskoho natsionalnoho medychnoho universytetu im. M.I. Pyrohova, Vinnytsia

27100

IRCCS Policlinico San Matteo, Università degli studi di Pavi, Pavia

28009

Centro Medico Instituto Palacios, Madrid

30030

iResearch Atlanta, LLC, Decatur

33016

Global Health Research Center, Miami Lakes

33155

Miami Clinical Research, Miami

37126

Azienda Ospedaliero Universitaria Integrata Verona, Veneto

89109

Excel Clinical Research - Internal Medicine, Las Vegas

Unknown

UMHAT Plovdiv, Plovdiv

Medical Center - Teodora EOOD, Rousse

Fakultni nemocnice Plzen, Pilsen

Semmelweis Egyetem, Budapest

702 00

APAVAR Lekarna, Ostrava

500 05

FN Hradec Kralove, Hradec Králové

339 01

Klatovska nemocnice, a.s., Klatovy

128 50

Revmatologicky ustav, Prague

148 00

Affidea Praha s.r.o., Prague

305 99

Fakultni nemocnice v Motole, Prague

06125

Azienda Ospedaliera di Perugia - Ospedale Santa Maria della, Perugia

31-559

Barbara Rewerska Diamond Clin., Krakow

20-607

Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda, Lublin

21-040

Lubelskie Centrum Diagnostyczne, Świdnik

02-507

Centralny Szpital Kliniczny MSWiA w Warszawie, Warsaw

15-082

Komisja Bioetyczna przy OIL w Bialymstoku, Bialystok

Nasz Lekarz Osrodek Badan Klinicznych, Bialystok

15-879

ClinicMed Daniluk, Nowak Sp. J, Bialystok

85-065

Nasz Lekarz Osrodek Badan Klinicznych, Bydgoszcz

81-338

Centrum Medyczne Pratia Gdynia, Gdynia

40-081

Centrum Medyczne Pratia Katowice, Katowice

30-363

Centrum Medyczne Plejady, Krakow

32-600

Oswiecimskie Centrum Badan Klinicznych, Oświęcim

96-500

RCMed Oddzial Sochaczew, Sochaczew

RCMed, Sochaczew

00-874

Medycyna Kliniczna, Warsaw

00-892

RCMed Oddział Warszawa, Warsaw

02-691

Centrum Medyczne Reuma Park, Warsaw

08208

Corporacio Sanitaria Parc Tauli de Sabadell - Servicio de reumatologia, Sabadell

08041

Hospital de La Santa Creu i Sant Pau, Barcelona

0 3037

"Medychnyi tsentr tovarystva z obmezhenoyu vidpovidalnistyu Medbud-Klinik", Kyiv

04114

"Derzhavna ustanova Instytut herontolohii imeni D.F. Chebotarova Natsionalnoi akademii medychnykh nauk Ukrainy", Kyiv

03049

"Kyivska klinichna likarnia na zaliznychnomu transporti #2 filii Tsentr okhorony zdoroviya AT Ukrayinska Zaliznytsia", Kiyiv

04210

"Med tsentr TOV Tsentr simeinoi medytsyny plius", Kiyiv

Sponsors
All Listed Sponsors
lead

Gedeon Richter Plc.

INDUSTRY