New osteoporosis drug shows promise in Head-to-Head trial
NCT ID NCT05405725
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial tested a new biosimilar drug called ENZ215 (a form of denosumab) against the established drug Prolia in 504 postmenopausal women with osteoporosis. The goal was to see if ENZ215 works as well as Prolia in improving bone density and reducing bone breakdown markers over 12 months. Researchers also monitored safety and immune responses. The study has been completed, and results will help determine if ENZ215 can be a cost-effective alternative.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
denosumab (a biosimilar to Prolia)
What this could lead to
If successful, this could provide a more affordable alternative to Prolia for treating osteoporosis in postmenopausal women.
What could go wrong
This is a biosimilar comparison, not a new treatment. Even if it works, it may not offer additional benefits over existing options. Long-term safety and effectiveness beyond 12 months are not yet established.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Centrum Medyczne Kuba- Med
Zamość, Poland
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Centrum Medyczne Pratia Czestochowa
Częstochowa, Poland
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Centrum Medyczne Pratia Gdynia
Gdynia, Poland
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Clinic
Prague, 14800, Czechia
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Clinical Hospital Centre Bezanijska Kosa
Zemun, Serbia
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DCC XVII-Sofia EOOD
Sofia, 1505, Bulgaria
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ETG Kielce, ul. Zagorska
Kielce, Poland
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ETG Lodz, ul. Pilota Stanislawa Wigury
Lodz, Poland
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ETG Lublin, ul. Kunickiego
Lublin, Poland
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ETG Siedlce
Siedlce, Poland
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Fakultni nemocnice v Motole
Prague, Czechia
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G-CENTRUM Olomouc
Horní Město, Czechia
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Hospital de La Santa Creu i Sant Pau
Barcelona, Spain
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Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50161, Lithuania
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Institute for Rheumatology
Belgrade, Serbia
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Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, Serbia
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JSC Saules seimos medicinos ce
Kaunas, 49449, Lithuania
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Kaunas City Polyclinic
Kaunas, 51270, Lithuania
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Krakowskie Centrum Medyczne
Krakow, Poland
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Lithuanian University of Health Sciences Hospital
Kaunas, Lithuania
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MEDICAL PLUS s.r.o.
Uherské Hradiště, Czechia
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Medical Center Teodora,
Rousse, 7000, Bulgaria
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National Osteoporosis Center
Vilnius, 09310, Lithuania
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Osteo-Medic S.C. A Racewicz
Bialystok, Poland
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Prywatna Praktyka Lekarska
Poznan, Poland
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Republican Siauliai Hospital
Šiauliai, Lithuania
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Research Center
Brno, 60200, Czechia
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Research Center
Pardubice, Czechia
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Research Center(Medical Center Synexus Sofia EOOD)
Sofia, 1784, Bulgaria
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Silmedic sp. z o.o.,ul. Gen. Wladyslawa Sikorskiego
Katowice, Poland
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Sydvestjysk Sygehus Esbjerg
Esbjerg, 6700, Denmark
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Synexus Czech
Prague, 12000, Czechia
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Synexus Polska
Częstochowa, Poland
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Synexus Polska
Gdansk, Poland
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Synexus Polska
Gdynia, Poland
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Synexus Polska
Katowice, Poland
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Synexus Polska
Lodz, Poland
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Synexus Polska
Poznan, Poland
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Synexus Polska
Warsaw, Poland
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Synexus Polska
Wroclaw, Poland
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Szpital Uniwersytecki
Bydgoszcz, Poland
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Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, Poland
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Twoja Przychodnia Nowosolskie Centrum Medyczne,
Nowa Sól, Poland
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Twoja Przychodnia PCM
Poznan, Poland
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University Hospital
Plovdiv, 4027, Bulgaria
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University Hospital.
Pilsen, Czechia
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Vilnius University Hospital Santaros Klinikos
Vilnius, 08661, Lithuania
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Zvezdara University Medical Center
Belgrade, Serbia