In short
Clinical trials are studying Setrusumab in people with osteogenesis imperfecta, also called brittle bone syndrome. These studies are looking at whether it can help reduce fractures and how it affects bone-related blood markers. The trials include children and adults and are testing different phases of research.
Key points
- Clinical trials are studying Setrusumab in people with osteogenesis imperfecta, also known as brittle bone syndrome. One study is in Phase 4 and one is in Phase 3, so both are later-stage trials. The studies include children and other people with OI. They are mainly looking at fracture rates, and one trial also measures a bone-related blood marker called P1NP. One trial compares Setrusumab with placebo, while the other compares it with intravenous bisphosphonates.
Trial overview
Two interventional studies are investigating Setrusumab in people with osteogenesis imperfecta (OI), which is also called brittle bone syndrome. Both studies are authorised and are focused on bone fracture outcomes.
The first study, NCT05125809, is a Phase 4 trial in 174 participants with OI. The second study, NCT05768854, is a Phase 3 trial in 68 pediatric subjects with osteogenesis imperfecta.
Who is being studied
The studies are looking at people with OI, a condition where bones are fragile and can break more easily than normal. One trial includes subjects with OI more broadly, while the other focuses on pediatric subjects, which means children.
No additional eligibility details are given in the trial data, so the main target population described is people with osteogenesis imperfecta.
What the trials measure
The main goal in both studies is to see whether Setrusumab can reduce fracture rate, which means how often broken bones happen over time. The fracture outcomes are measured by the annualized rate of radiographically-confirmed fractures, meaning fractures that are confirmed by imaging such as X-rays.
In NCT05125809, the Phase II part also looks at the percent change in serum P1NP from baseline at Month 1. P1NP is a blood marker linked to bone formation, so this measure helps researchers see how the study treatment may affect bone-building activity.
The Phase III part of NCT05125809 excludes some fracture types from the main analysis, including morphometric vertebral fractures and fractures of the fingers, toes, face, and skull. In contrast, NCT05768854 includes morphometric vertebral fractures in its primary fracture outcome.
What Setrusumab is compared with
In NCT05125809, Setrusumab is compared with placebo, which is an inactive treatment used to help show whether the study drug has an effect. This trial also lists dextrose or glucose 5% solution in water as part of the intervention information.
In NCT05768854, Setrusumab is compared with intravenous bisphosphonates, a group of bone medicines given through a vein. The listed comparison treatments include several bisphosphonate products such as zoledronate, pamidronate, and neridronate formulations.
Trial phases and status
NCT05125809 is a Phase 4 study and is marked as authorised. Phase 4 studies are later-stage studies that can help show how a treatment performs in broader use.
NCT05768854 is a Phase 3 study and is also marked as authorised. Phase 3 studies are later-stage trials that usually compare treatments in larger groups to learn more about benefit and outcome differences.