Can a biosimilar match prolia in strengthening bones?
NCT ID NCT06804590
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This trial tests whether an experimental biosimilar called 9MW0311 works as well as the established drug Prolia (both containing denosumab) in postmenopausal women with osteoporosis who are at high risk for fractures. Participants receive either 9MW0311 or Prolia as an injection every six months for a year. The study measures changes in bone density and monitors safety and immune response to see if the biosimilar is a viable 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 (biosimilar 9MW0311) compared with Prolia (denosumab)
- What this could lead to
- If successful, this could provide a more affordable, equally effective option for treating osteoporosis and reducing fracture risk in postmenopausal women.
- What could go wrong
- This is a phase III trial, but results may not match Prolia exactly, and long-term safety or immunogenicity differences could emerge. The study is limited to a specific population.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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
Locations
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Mabwell (Shanghai) Bioscience Co., Ltd.
Beijing, China