#1 Clinical Trials Search in Europe

Setrusumab

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.

Table of Contents

Trial overview

Two interventional studies are investigating Setrusumab in people with osteogenesis imperfecta (OI), which is also called brittle bone syndrome.[1][2] Both studies are authorised and are focused on bone fracture outcomes.[1][2]

The first study, NCT05125809, is a Phase 4 trial in 174 participants with OI.[1] The second study, NCT05768854, is a Phase 3 trial in 68 pediatric subjects with osteogenesis imperfecta.[2]

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.[1][2] One trial includes subjects with OI more broadly, while the other focuses on pediatric subjects, which means children.[1][2]

No additional eligibility details are given in the trial data, so the main target population described is people with osteogenesis imperfecta.[1][2]

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.[1][2] The fracture outcomes are measured by the annualized rate of radiographically-confirmed fractures, meaning fractures that are confirmed by imaging such as X-rays.[1][2]

In NCT05125809, the Phase II part also looks at the percent change in serum P1NP from baseline at Month 1.[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.[1]

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.[1] In contrast, NCT05768854 includes morphometric vertebral fractures in its primary fracture outcome.[2]

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.[1] This trial also lists dextrose or glucose 5% solution in water as part of the intervention information.[1]

In NCT05768854, Setrusumab is compared with intravenous bisphosphonates, a group of bone medicines given through a vein.[2] The listed comparison treatments include several bisphosphonate products such as zoledronate, pamidronate, and neridronate formulations.[2]

Trial phases and status

NCT05125809 is a Phase 4 study and is marked as authorised.[1] Phase 4 studies are later-stage studies that can help show how a treatment performs in broader use.[1]

NCT05768854 is a Phase 3 study and is also marked as authorised.[2] Phase 3 studies are later-stage trials that usually compare treatments in larger groups to learn more about benefit and outcome differences.[2]

Trial ID Phase Condition studied Status Enrollment
NCT05125809 Phase 4 Osteogenesis imperfecta (OI) Authorised 174
NCT05768854 Phase 3 Osteogenesis imperfecta Authorised 68

FAQ

  • What condition are Setrusumab trials studying? The trials are studying osteogenesis imperfecta, which is also called brittle bone syndrome. This is a condition where bones break more easily than normal.
  • Who can take part in these trials? The studies include people with osteogenesis imperfecta. One trial is in pediatric subjects, which means children, and another includes subjects with OI more broadly.
  • What are the trials trying to find out? The trials are checking whether Setrusumab can lower fracture rates and improve bone-related measures. One study also looks at a blood marker called P1NP, which helps show bone formation.
  • What phases are the Setrusumab trials in? The trials are in Phase 3 and Phase 4. These later phases usually look more closely at how well a treatment works in larger groups of people.
  • What treatments are being compared with Setrusumab? One trial compares Setrusumab with placebo, which is an inactive treatment. Another compares Setrusumab with intravenous bisphosphonates, which are bone medicines given through a vein.

Ongoing Clinical Trials on Setrusumab

  • Study Comparing Setrusumab and Bisphosphonates for Children with Osteogenesis Imperfecta

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Poland

  • Study on Setrusumab for Patients with Osteogenesis Imperfecta (Brittle Bone Disease)

    Not recruiting

    4 1
    Investigated drugs:
    France Germany Italy The Netherlands Poland Portugal

Glossary

  • Osteogenesis imperfecta (OI): A condition also called brittle bone syndrome. People with OI have bones that break more easily than normal.
  • Brittle bone syndrome: A common name for osteogenesis imperfecta. It means the bones are fragile and can fracture easily.
  • Phase 3: A later stage of clinical research that tests how well a treatment works and watches safety in a larger group.
  • Phase 4: A study stage done after earlier research. It can look at how a treatment performs in real-world or expanded settings.
  • Interventional study: A study where participants receive a treatment or comparison treatment so researchers can measure the effect.
  • Placebo: An inactive treatment used for comparison. It helps researchers see whether the study drug has a real effect.
  • Bisphosphonates: A group of bone medicines used as a comparison in one trial. In these studies, they are given through a vein.
  • Intravenous use: Given through a vein, usually by infusion.
  • Infusion: A way of giving medicine slowly into a vein over time.
  • Fracture rate: How often broken bones happen in a group of people over a set time.
  • Radiographically-confirmed fracture: A broken bone that is confirmed by an imaging test, such as an X-ray.
  • P1NP: A blood marker used in one trial to help measure bone formation.

References