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Postmenopausal OsteoporosisPhase 3NCT05087030

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

A Phase 3 study testing RGB-14-P and Prolia® in people with Postmenopausal Osteoporosis, run by Gedeon Richter Plc. at 59 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 60 to 90 years, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
RGB-14-P and Prolia®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
473 participants
Where
59 sitesin 8 countries
Study dates
21 Sep 2021to 15 Nov 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

59 sites in 8 countries.

59 sites in 8 countries

Poland17 sites

  • Komisja Bioetyczna przy OIL w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-082

  • Nasz Lekarz Osrodek Badan Klinicznych

    Bialystok, Podlaskie Voivodeship, 15-082

  • ClinicMed Daniluk, Nowak Sp. J

    Bialystok, Podlaskie Voivodeship, 15-879

  • Nasz Lekarz Osrodek Badan Klinicznych

    Bydgoszcz, 85-065

  • Centrum Medyczne Pratia Gdynia

    Gdynia, 81-338

  • Centrum Medyczne Pratia Katowice

    Katowice, 40-081

  • Barbara Rewerska Diamond Clin.

    Krakow, Lesser Poland Voivodeship, 31-559

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda

    Lublin, Lublin Voivodeship, 20-607

  • Oswiecimskie Centrum Badan Klinicznych

    Oświęcim, 32-600

  • RCMed Oddzial Sochaczew

    Sochaczew, 96-500

  • RCMed

    Sochaczew, 96-500

  • Lubelskie Centrum Diagnostyczne

    Świdnik, Lublin Voivodeship, 21-040

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw, Masovian Voivodeship, 02-507

  • Medycyna Kliniczna

    Warsaw, 00-874

  • RCMed Oddział Warszawa

    Warsaw, 00-892

  • Centrum Medyczne Reuma Park

    Warsaw, 02-691

Other trials in Poland

Bulgaria10 sites

  • Medical Center Medconsult Pleven

    Pleven, 5803

  • UMHAT Kaspela

    Plovdiv, 4001

  • DKC "Sveti Georgi"

    Plovdiv, 4002

  • UMHAT Kaspela (Endocrinology/metabolic disease)

    Plovdiv, 4002

  • UMHAT Pulmed - Reumathology

    Plovdiv, 4002

  • UMHAT Plovdiv

    Plovdiv

  • Medical Center - Teodora EOOD

    Rousse

  • Medical Center Hera EOOD - Rheumatology Office

    Sofia, Sofia-Grad, 1510

  • Medical Center Excelsior

    Sofia, 1407

  • "DCC XVII-Sofia" EOOD

    Sofia, 1505

Other trials in Bulgaria

Czechia7 sites

  • FN Hradec Kralove

    Hradec Králové, 500 05

  • Klatovska nemocnice, a.s.

    Klatovy, 339 01

  • APAVAR Lekarna

    Ostrava, Ostrava-město, 702 00

  • Fakultni nemocnice Plzen

    Pilsen

  • Revmatologicky ustav

    Prague, 128 50

  • Affidea Praha s.r.o.

    Prague, 148 00

  • Fakultni nemocnice v Motole

    Prague, 305 99

Other trials in Czechia

Hungary6 sites

  • Qualiclinic Kft.

    Budapest, 1036

  • Semmelweis Egyetem

    Budapest

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdú-Bihar, 4032

  • Pest Megyei Flor Ferenc Korhaz

    Kistarcsa, 2143

  • BAZM KKH EOK Szt Ferenc Tagkh

    Miskolc, Borsod-Abauj Zemplen county, 3529

  • Csongrad Megyei Dr Bugyi Istvan Korhaz

    Szentes, 6600

Other trials in Hungary

Spain6 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 08041

  • Centro Medico Instituto Palacios

    Madrid, 28009

  • Corporacio Sanitaria Parc Tauli de Sabadell - Servicio de reumatologia

    Sabadell, Barcelona, 08208

  • H. Ntra. Sra. de la Esperanza

    Santiago de Compostela, A Coruña, 15705

  • Clinica Gaias Santiago

    Santiago de Compostela, 15703

Other trials in Spain

Ukraine6 sites

  • Medychnyi tsentr tovarystva z obmezhenoyu vidpovidalnistyu "Medbud-Klinik"

    Kyiv, Kyïv, 0 3037

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

    Kyiv, Kyïv, 04114

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

    Kyiv, 03049

  • Med tsentr TOV "Tsentr simeinoi medytsyny plius"

    Kyiv, 04210

  • Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova

    Vinnytsia, Vinnytsia Oblast, 21018

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

    Vinnytsia, Vinnytsia Oblast, 21029

Other trials in Ukraine

United States4 sites

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • Excel Clinical Research - Internal Medicine

    Las Vegas, Nevada, 89109

  • Miami Clinical Research

    Miami, Florida, 33155

  • Global Health Research Center

    Miami Lakes, Florida, 33016

Other trials in United States

Italy3 sites

  • IRCCS Policlinico San Matteo, Università degli studi di Pavi

    Pavia, 27100

  • Azienda Ospedaliera di Perugia - Ospedale Santa Maria della

    Perugia, 06125

  • Azienda Ospedaliero Universitaria Integrata Verona

    Veneto, 37126

Other trials in Italy

About this study

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

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.

Read the detailed 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).

Being tested
RGB-14-P, Prolia®
Keywords
Biosimilars, Prolia®
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RGB-14-PDrug

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

  • Prolia®Drug

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

Study groups in NCT05087030
Study groupRoleWhat they receive
RGB-14-P (Main period)ExperimentalRandomized participants will receive subcutaneous (SC) injection of RGB-14-P, on Day 1 of Treatment periods 1 and 2.
Receives: Drug: RGB-14-P
Prolia® (Main period)Active comparatorRandomized participants will receive SC injection of Prolia®, on Day 1 of Treatment periods 1 and 2.
Receives: Drug: Prolia®
RGB-14-P (Transition period)ExperimentalRe-randomized participants will receive SC injection of RGB-14-P, on Day 1 of Treatment period 3.
Receives: Drug: RGB-14-P
Prolia® (Transition period)Active comparatorRe-randomized participants will receive SC injection of Prolia®, on Day 1 of Treatment period 3.
Receives: Drug: Prolia®
RGB-14-P (Continued till transition period)ExperimentalRandomized participants will continue to receive SC injection of RGB-14-P from the main period till Day 1 of Treatment period 3.
Receives: Drug: RGB-14-P

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 52

  2. 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.

    Measured: Week 26

Secondary outcomes (11)

  1. %CfB in Total Hip BMD

    %CfB in total hip BMD was assessed.

    Measured: Weeks 26, 52 and 78

  2. %CfB in Lumbar Spine BMD

    %CfB in lumbar spine BMD was assessed.

    Measured: Weeks 26 and 78

  3. %CfB in Femoral Neck BMD

    %CfB in femoral neck BMD was assessed by DXA.

    Measured: Weeks 26, 52 and 78

  4. 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.

    Measured: Weeks 52 and 78

  5. 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.

    Measured: Weeks 52 and 78

  6. %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.

    Measured: Weeks 4, 26, 52 and 78

  7. %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.

    Measured: Weeks 4, 26, 52 and 78

  8. 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.

    Measured: Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78

  9. Number of Participants With Anti-drug Antibodies (ADAs)

    Number of participants with positive ADAs was assessed.

    Measured: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78

  10. Number of Participants With Neutralizing Antibodies

    Number of participants with positive neutralizing antibodies was assessed.

    Measured: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78

  11. Titre of ADAs

    The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed.

    Measured: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2021
  2. Study start21 Sep 2021
  3. Primary completion2 Oct 2023
  4. Study completion15 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
473 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05087030
Sponsor's protocol ID
RGB 14 101
Other IDs
2020 006017 38
Status last verified
Sep 2024
First submitted
8 Oct 2021
Last updated
24 Oct 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RGB-14-P and Prolia® in people with Postmenopausal Osteoporosis, run by Gedeon Richter Plc. at 59 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Poland, Bulgaria, Czechia, Hungary, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD) (time frame: Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05087030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.

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