NCT05087030COMPLETEDanonymous

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

Sponsor

Source record

Gedeon Richter Plc.

Phase

Source record

PHASE3

Modality

AI-normalized

small molecule

Target

AI-normalized

RGB-14-P, Prolia®

Indication / condition

AI-normalized

Postmenopausal Osteoporosis

Intervention

Source record

RGB-14-P, Prolia®

Related intelligence directories

Indication directory: Postmenopausal Osteoporosis Modality directory: small molecule Target directory: RGB-14-P

Source & freshness

Source record

NCT ID

NCT05087030

Original source

ClinicalTrials.gov

Source last updated

Oct 24, 2024

Ingested at

May 30, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record

View original source fields

NCT ID

NCT05087030

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

Sponsor

Gedeon Richter Plc.

Status

COMPLETED

Phase

PHASE3

Condition raw

Postmenopausal Osteoporosis

Condition normalized

Postmenopausal Osteoporosis

Modality raw

small molecule

Modality normalized

small molecule

Target raw

RGB-14-P, Prolia®

Target normalized

RGB-14-P, Prolia®

Interventions

RGB-14-P, Prolia®

Public preview

Source record

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.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

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

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 20, 2026

NCT ID

NCT05087030

Status

COMPLETED

Phase

PHASE3

Sponsor

Gedeon Richter Plc.

Executive brief

Investment-Ready Snapshot

Source & freshness

Provenance

SourceClinicalTrials.gov

Source updatedOct 24, 2024

Internal syncJun 05, 2026

Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT05087030

Indication

Postmenopausal Osteoporosis

Modality

small molecule

Target

RGB-14-P, Prolia®

Intervention

RGB-14-P, Prolia®

Source record