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Romosozumab

Clinical trials are studying Romosozumab in different patient groups, including children and adolescents with osteogenesis imperfecta and women with osteoporosis. These studies look at safety, fracture outcomes, bone density, and, in one trial, coronary atherosclerotic damage. The goal is to learn how Romosozumab performs in these specific research settings.

Table of Contents

Clinical trial overview

The trial data show four interventional studies of Romosozumab in different patient groups.[1][2][3][4] The studies are authorised and include Phase 3 research, one low-intervention study, and one Phase IV study.[1][2][3][4] They focus on bone disease, fracture prevention, safety, and one heart-related imaging outcome in women with postmenopausal osteoporosis.[1][2][3][4]

Studies in osteogenesis imperfecta

Two studies are in children, adolescents, and other participants with osteogenesis imperfecta, a condition where bones break more easily than normal.[1][3] One Phase 3 study compares Romosozumab with bisphosphonates over 12 months and includes 122 participants.[1] Its main goal is to measure the number of clinical fractures, the number of any fractures, and the change in lumbar spine bone mineral density measured by DXA, which is a scan used to check bone density.[1]

The second osteogenesis imperfecta study is a pediatric safety follow-up study with 71 participants.[3] It follows children and adolescents who already completed an earlier study of Romosozumab, whether they received the full planned treatment or stopped early.[3] The main outcome is adverse events, meaning any unwanted medical problems seen during follow-up.[3]

Studies in osteoporosis

The OPTIMIST study looks at Romosozumab in people with osteoporosis, a condition that makes bones weak and more likely to break.[2] This study includes 270 participants and is designed to identify the best way to use Romosozumab by testing three treatment strategies.[2] The primary outcome is the change in total hip bone mineral density after 24 months, which helps show whether bone strength improves over time.[2]

This study compares Romosozumab with Aclasta, which is listed in the trial data as a comparison treatment.[2] The study is described as low-intervention, meaning it uses treatment in a way that is close to usual care with limited extra research procedures.[2]

Study of coronary atherosclerotic damage

The ATRIO study is a Phase 3 trial in women with postmenopausal osteoporosis and coronary atherosclerotic status, meaning the condition of plaque-related damage in the heart arteries.[4] It includes 60 participants and compares Romosozumab with denosumab.[4] The main outcome is the change in a coronary CT score adapted to the CCTA-Leaman method after 12 months of therapy.[4]

This study is important because it does not only look at bone health, but also at a heart-artery imaging measure in a group of women already being treated for postmenopausal osteoporosis.[4] The trial summary says the goal is to study the impact of Romosozumab, given according to standard care, on progression of coronary atherosclerotic damage compared with denosumab.[4]

Main outcomes being measured

The trials measure different outcomes depending on the condition being studied.[1][2][3][4] In the osteogenesis imperfecta study, researchers measure clinical fractures, any fractures, and lumbar spine bone mineral density Z-score at 12 months.[1] In the pediatric follow-up study, the main focus is safety through adverse events.[3]

In the OPTIMIST study, the main outcome is total hip bone mineral density at 24 months.[2] In the ATRIO study, the main outcome is the coronary CT score after 12 months, which is used to track coronary artery damage.[4] These outcomes help researchers judge whether the treatment strategies are effective and safe in each target group.[1][2][3][4]

Who can participate

People in these trials are selected based on the condition being studied and the age group of the trial.[1][2][3][4] The listed studies include children and adolescents with osteogenesis imperfecta, participants with osteoporosis, and women with postmenopausal osteoporosis.[1][2][3][4]

Because these are clinical trials, each study has its own entry rules and treatment plan.[1][2][3][4] The trial data show that Romosozumab is being studied in both bone-focused research and one study that also examines a heart-related imaging outcome.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
2023-503294-37-00 Phase 3 Osteogenesis Imperfecta Authorised 122
2023-505940-20-00 Low Intervention Osteoporosis Authorised 270
2023-503293-21-00 Phase 3 Osteogenesis Imperfecta Authorised 71
2025-522592-29-00 Phase 3 Coronary atherosclerotic status in women with postmenopausal osteoporosis Authorised 60

FAQ

  • Who can take part in Romosozumab clinical trials? The trials listed include children and adolescents with osteogenesis imperfecta, people with osteoporosis, and women with postmenopausal osteoporosis. Each study has its own rules for who can join.
  • What are the trials studying? The trials are studying fracture rates, bone mineral density, safety, and, in one study, coronary atherosclerotic damage. They also compare Romosozumab with other treatments such as bisphosphonates and denosumab.
  • What trial phases are included? The data include Phase 3 studies and one Phase IV study. One study is also described as a low-intervention trial.
  • Which conditions are being studied? The main conditions are osteogenesis imperfecta, osteoporosis, and postmenopausal osteoporosis. One study focuses on coronary atherosclerotic status in women with postmenopausal osteoporosis.
  • What outcomes are measured in these trials? The outcomes include the number of fractures, changes in lumbar spine and total hip bone mineral density, adverse events, and change in coronary CT score. These outcomes help researchers judge benefit and safety.

Ongoing Clinical Trials on Romosozumab

  • A safety study of romosozumab in children and adolescents with osteogenesis imperfecta

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Germany Hungary Italy Slovakia +1

  • Study on the Use of Romosozumab and Zoledronic Acid for Treating Osteoporosis in Patients

    Recruiting

    3 1 1 1
    Investigated drugs:
    Denmark

  • Comparing the effect of romosozumab and denosumab on coronary artery damage in women with postmenopausal osteoporosis

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Effects of Romosozumab and Bisphosphonates in Children and Adolescents with Osteogenesis Imperfecta

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Austria Belgium France Germany Hungary Italy +3

Glossary

  • Osteogenesis Imperfecta: A condition that makes bones break more easily than normal.
  • Osteoporosis: A condition where bones become weak and less dense, so they can break more easily.
  • Postmenopausal osteoporosis: Osteoporosis that happens after menopause, when hormone changes can affect bone strength.
  • Phase 3: A later stage of clinical research that usually compares a treatment with another treatment or standard care in a larger group.
  • Phase IV: A study done after a treatment is already in use, often to learn more about its effects in real-world care.
  • Interventional study: A study where participants receive a treatment or comparison treatment chosen by the researchers.
  • Low-intervention study: A study that uses treatments as part of usual care with limited extra research procedures.
  • Bone mineral density (BMD): A measure of how much mineral is in the bones. Higher values usually mean stronger bones.
  • Lumbar spine: The lower part of the back, where the study measures bone density.
  • DXA: A scan used to measure bone mineral density. It is a common way to check bone strength.
  • Adverse events: Unwanted medical problems that happen during a study, whether or not they are caused by the treatment.
  • Coronary CT score: A score from a heart scan that helps researchers measure damage in the coronary arteries, which supply blood to the heart.

References

  1. https://clinicaltrials.gov/study/2023-503294-37-00
  2. https://clinicaltrials.gov/study/2023-505940-20-00
  3. https://clinicaltrials.gov/study/2023-503293-21-00
  4. https://clinicaltrials.gov/study/2025-522592-29-00