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

Completed · Phase 3

Conditions studied: Postmenopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT05087030

Run by

Gedeon Richter Plc.

People needed

473

Starts

2021-09-21

Expected to finish

2023-11-15

Last updated by the study team

2024-10-24

Who can join

Age: 60 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Global Health Research Center — Miami Lakes, Florida, United States
• iResearch Atlanta, LLC — Decatur, Georgia, United States
• Excel Clinical Research - Internal Medicine — Las Vegas, Nevada, United States
• Medical Center Hera EOOD - Rheumatology Office — Sofia, Sofia-Grad, Bulgaria
• Medical Center Medconsult Pleven — Pleven, Bulgaria
• UMHAT Kaspela — Plovdiv, Bulgaria
• DKC "Sveti Georgi" — Plovdiv, Bulgaria
• UMHAT Kaspela (Endocrinology/metabolic disease) — Plovdiv, Bulgaria
• UMHAT Pulmed - Reumathology — Plovdiv, Bulgaria
• UMHAT Plovdiv — Plovdiv, Bulgaria
• Medical Center - Teodora EOOD — Rousse, Bulgaria
• Medical Center Excelsior — Sofia, Bulgaria
• "DCC XVII-Sofia" EOOD — Sofia, Bulgaria
• APAVAR Lekarna — Ostrava, Ostrava-město, Czechia
• FN Hradec Kralove — Hradec Králové, Czechia
• Klatovska nemocnice, a.s. — Klatovy, Czechia
• Fakultni nemocnice Plzen — Pilsen, Czechia
• Revmatologicky ustav — Prague, Czechia
• Affidea Praha s.r.o. — Prague, Czechia
• Fakultni nemocnice v Motole — Prague, Czechia
• BAZM KKH EOK Szt Ferenc Tagkh — Miskolc, Borsod-Abauj Zemplen county, Hungary
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hajdú-Bihar, Hungary
• Qualiclinic Kft. — Budapest, Hungary
• Semmelweis Egyetem — Budapest, Hungary
• Miami Clinical Research — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.