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

Primary Purpose

Postmenopausal Osteoporosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RGB-14-P
Prolia®
Sponsored by
Gedeon Richter Plc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Biosimilars, Prolia®

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 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

Sites / Locations

  • Global Health Research Center
  • Miami Clinical Research
  • iResearch Atlanta, LLC
  • Excel Clinical Research - Internal Medicine
  • Medical Center Hera EOOD - Rheumatology Office
  • Medical Center Medconsult Pleven
  • UMHAT Kaspela
  • DKC "Sveti Georgi"
  • UMHAT Kaspela (Endocrinology/metabolic disease)
  • UMHAT Pulmed - Reumathology
  • UMHAT Plovdiv
  • Medical Center - Teodora EOOD
  • Medical Center Excelsior
  • "DCC XVII-Sofia" EOOD
  • APAVAR Lekarna
  • FN Hradec Kralove
  • Klatovska nemocnice, a.s.
  • Fakultni nemocnice Plzen
  • Affidea Praha s.r.o.
  • Revmatologicky ustav
  • Fakultni nemocnice v Motole
  • BAZM KKH EOK Szt Ferenc Tagkh
  • Debreceni Egyetem Klinikai Kozpont
  • Qualiclinic Kft.
  • Semmelweis Egyetem
  • Pest Megyei Flor Ferenc Korhaz
  • Csongrad Megyei Dr Bugyi Istvan Korhaz
  • IRCCS Policlinico San Matteo, Università degli studi di Pavi
  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della
  • Azienda Ospedaliero Universitaria Integrata Verona
  • Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda
  • Lubelskie Centrum Diagnostyczne
  • Barbara Rewerska Diamond Clin.
  • Centralny Szpital Kliniczny MSWiA w Warszawie
  • Nasz Lekarz Osrodek Badan Klinicznych
  • ClinicMed Daniluk, Nowak Sp. J
  • Komisja Bioetyczna przy OIL w Bialymstoku
  • Nasz Lekarz Osrodek Badan Klinicznych
  • Centrum Medyczne Pratia Gdynia
  • Centrum Medyczne Pratia Katowice
  • Centrum Medyczne Plejady
  • Oswiecimskie Centrum Badan Klinicznych
  • RCMed Oddzial Sochaczew
  • RCMed
  • Medycyna Kliniczna
  • RCMed Oddział Warszawa
  • Centrum Medyczne Reuma Park
  • H. Ntra. Sra. de la Esperanza
  • Corporacio Sanitaria Parc Tauli de Sabadell - Servicio de reumatologia
  • Complejo Hospitalario Universitario A Coruña
  • Hospital de La Santa Creu i Sant Pau
  • Centro Medico Instituto Palacios
  • Clinica Gaias Santiago
  • Medychnyi tsentr tovarystva z obmezhenoyu vidpovidalnistyu "Medbud-Klinik"
  • Derzhavna ustanova "Instytut herontolohii imeni D.F. Chebotarova Natsionalnoi akademii medychnykh nauk Ukrainy
  • Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova
  • Naukovo-doslidnyi instytut reabilitatsii osib z invalidnistiu (navchalno-naukovo-likuvalnyi kompleks) Vinnytskoho natsionalnoho medychnoho universytetu im. M.I. Pyrohova
  • Kyivska klinichna likarnia na zaliznychnomu transporti #2 filii "Tsentr okhorony zdoroviya" AT "Ukrayinska Zaliznytsia"
  • Med tsentr TOV "Tsentr simeinoi medytsyny plius"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

RGB-14-P (Main period)

Prolia® (Main period)

RGB-14-P (Transition period)

Prolia® (Transition period)

RGB-14-P (Continued till transition period)

Arm Description

Randomized participants will receive subcutaneous (SC) injection of RGB-14-P, on Day 1 of Treatment periods 1 and 2.

Randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment periods 1 and 2.

Re-randomized participants will receive SC injection of RGB-14-P, on Day 1 of Treatment period 3.

Re-randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment period 3.

Randomized participants will continue to receive SC injection of RGB-14-P from the main period till Day 1 of Treatment period 3.

Outcomes

Primary Outcome Measures

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.
Area under the effective curve after the first dose until Day 183 of percentage 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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 8, 2021
Last Updated
October 24, 2023
Sponsor
Gedeon Richter Plc.
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1. Study Identification

Unique Protocol Identification Number
NCT05087030
Brief Title
Comparative Efficacy and Safety Study of RGB-14-P and Prolia® in Women With Postmenopausal Osteoporosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gedeon Richter Plc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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®. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Biosimilars, Prolia®

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
A double-blind design will be used during the main and transition periods.
Allocation
Randomized
Enrollment
473 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RGB-14-P (Main period)
Arm Type
Experimental
Arm Description
Randomized participants will receive subcutaneous (SC) injection of RGB-14-P, on Day 1 of Treatment periods 1 and 2.
Arm Title
Prolia® (Main period)
Arm Type
Active Comparator
Arm Description
Randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment periods 1 and 2.
Arm Title
RGB-14-P (Transition period)
Arm Type
Experimental
Arm Description
Re-randomized participants will receive SC injection of RGB-14-P, on Day 1 of Treatment period 3.
Arm Title
Prolia® (Transition period)
Arm Type
Active Comparator
Arm Description
Re-randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment period 3.
Arm Title
RGB-14-P (Continued till transition period)
Arm Type
Experimental
Arm Description
Randomized participants will continue to receive SC injection of RGB-14-P from the main period till Day 1 of Treatment period 3.
Intervention Type
Drug
Intervention Name(s)
RGB-14-P
Intervention Description
Participants will receive RGB-14-P into the thigh, abdomen, or upper arm as per the arm assigned.
Intervention Type
Drug
Intervention Name(s)
Prolia®
Intervention Description
Participants will receive Prolia® into the thigh, abdomen, or upper arm as per the arm assigned.
Primary Outcome Measure Information:
Title
Percentage change from baseline in lumbar spine bone mineral density (BMD)
Description
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.
Time Frame
Baseline, Week 52
Title
Area under the effective curve after the first dose until Day 183 of percentage change from baseline in serum type I collagen C-telopeptide up to month 6 (AUEC of %CfB in sCTX00-m6) until Week 26
Description
Similar pharmacodynamics (AUEC of %CfB in sCTX) of RGB-14-P with US-licensed Prolia® in female participants will be demonstrated with postmenopausal osteoporosis.
Time Frame
Baseline, until Week 26 (Predose)
Secondary Outcome Measure Information:
Title
Percentage change from baseline in total hip BMD
Description
Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
Time Frame
Baseline, Weeks 26, 52 and 78
Title
Percentage change from baseline in lumbar spine BMD
Description
Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
Time Frame
Baseline, Weeks 26 and 78
Title
Percentage change from baseline in femoral neck BMD
Description
Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
Time Frame
Baseline, Weeks 26, 52 and 78
Title
Vertebral fragility fracture incidence
Description
Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
Time Frame
Weeks 52 and 78
Title
Non-vertebral fragility fracture incidence
Description
Additional comparative efficacy data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
Time Frame
Weeks 52 and 78
Title
Percentage change from baseline in serum procollagen type 1 N terminal propeptide (P1NP)
Description
Additional comparative pharmacodynamic data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
Time Frame
Baseline, Weeks 4, 26, 52 and 78
Title
Percentage change from baseline in serum type I collagen C-telopeptide (sCTX)
Description
Additional comparative pharmacodynamic data of RGB-14-P with US-licensed Prolia® will be evaluated in female participants with postmenopausal osteoporosis.
Time Frame
Baseline, Weeks 4, 26, 52 and 78
Title
Number of participants with adverse events (AEs)
Description
The safety and tolerability of RGB-14-P with US-licensed Prolia® will be compared in female participants with postmenopausal osteoporosis will be compared.
Time Frame
From Screening (Weeks -5 to 0) until Week 78
Title
Number of participants with anti-drug antibodies (ADAs) and neutralizing antibodies
Description
The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis will be compared.
Time Frame
Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Title
Titre of ADAs against RGB-14-P
Description
The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis will be compared.
Time Frame
Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Facility Information:
Facility Name
Global Health Research Center
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Miami Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Excel Clinical Research - Internal Medicine
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Medical Center Hera EOOD - Rheumatology Office
City
Sofia
State/Province
Sofia-Grad
ZIP/Postal Code
1510
Country
Bulgaria
Facility Name
Medical Center Medconsult Pleven
City
Pleven
ZIP/Postal Code
5803
Country
Bulgaria
Facility Name
UMHAT Kaspela
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
DKC "Sveti Georgi"
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT Kaspela (Endocrinology/metabolic disease)
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT Pulmed - Reumathology
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT Plovdiv
City
Plovdiv
Country
Bulgaria
Facility Name
Medical Center - Teodora EOOD
City
Ruse
Country
Bulgaria
Facility Name
Medical Center Excelsior
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
"DCC XVII-Sofia" EOOD
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
APAVAR Lekarna
City
Ostrava
State/Province
Ostrava-město
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
FN Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Klatovska nemocnice, a.s.
City
Klatovy
ZIP/Postal Code
339 01
Country
Czechia
Facility Name
Fakultni nemocnice Plzen
City
Plzen
Country
Czechia
Facility Name
Affidea Praha s.r.o.
City
Praha 11
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
BAZM KKH EOK Szt Ferenc Tagkh
City
Miskolc
State/Province
Borsod-Abaúj-Zemplén
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
State/Province
Hajdú-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Qualiclinic Kft.
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
Country
Hungary
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Csongrad Megyei Dr Bugyi Istvan Korhaz
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
IRCCS Policlinico San Matteo, Università degli studi di Pavi
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera di Perugia - Ospedale Santa Maria della
City
Perugia
ZIP/Postal Code
06125
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Integrata Verona
City
Veneto
ZIP/Postal Code
37126
Country
Italy
Facility Name
Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Lubelskie Centrum Diagnostyczne
City
Świdnik
State/Province
Lubelskie
ZIP/Postal Code
21-040
Country
Poland
Facility Name
Barbara Rewerska Diamond Clin.
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Centralny Szpital Kliniczny MSWiA w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-082
Country
Poland
Facility Name
ClinicMed Daniluk, Nowak Sp. J
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Komisja Bioetyczna przy OIL w Bialymstoku
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-082
Country
Poland
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Centrum Medyczne Pratia Katowice
City
Katowice
ZIP/Postal Code
40-081
Country
Poland
Facility Name
Centrum Medyczne Plejady
City
Kraków
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Oswiecimskie Centrum Badan Klinicznych
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
RCMed Oddzial Sochaczew
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
RCMed
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Medycyna Kliniczna
City
Warszawa
ZIP/Postal Code
00-874
Country
Poland
Facility Name
RCMed Oddział Warszawa
City
Warszawa
ZIP/Postal Code
00-892
Country
Poland
Facility Name
Centrum Medyczne Reuma Park
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
H. Ntra. Sra. de la Esperanza
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15705
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli de Sabadell - Servicio de reumatologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Centro Medico Instituto Palacios
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Clinica Gaias Santiago
City
Santiago De Compostela
ZIP/Postal Code
15703
Country
Spain
Facility Name
Medychnyi tsentr tovarystva z obmezhenoyu vidpovidalnistyu "Medbud-Klinik"
City
Kyiv
State/Province
Kyïv
ZIP/Postal Code
0 3037
Country
Ukraine
Facility Name
Derzhavna ustanova "Instytut herontolohii imeni D.F. Chebotarova Natsionalnoi akademii medychnykh nauk Ukrainy
City
Kyiv
State/Province
Kyïv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova
City
Vinnytsia
State/Province
Vinnyts'ka Oblast'
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Naukovo-doslidnyi instytut reabilitatsii osib z invalidnistiu (navchalno-naukovo-likuvalnyi kompleks) Vinnytskoho natsionalnoho medychnoho universytetu im. M.I. Pyrohova
City
Vinnytsia
State/Province
Vinnyts'ka Oblast'
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Kyivska klinichna likarnia na zaliznychnomu transporti #2 filii "Tsentr okhorony zdoroviya" AT "Ukrayinska Zaliznytsia"
City
Kyïv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Med tsentr TOV "Tsentr simeinoi medytsyny plius"
City
Kyïv
ZIP/Postal Code
04210
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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