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New drug aims to slash fractures in kids with brittle bones

NCT ID NCT05972551

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called romosozumab against standard bone-strengthening medicines (bisphosphonates) in children and teens with osteogenesis imperfecta, a condition that causes fragile bones and frequent fractures. The goal is to see if romosozumab can reduce the number of fractures and improve bone density over 12 months. About 111 participants will be randomly assigned to one of the two treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

111 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures. OR * Participant's legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated. * Ambulatory male and female children and adolescents, age 5 to \<18 years, including ambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI) population. * Clinical diagnosis of OI, defined as clinical history consistent with type I, III, or IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis). o If familial, also must be autosomal dominant. * Meets at least one of the following: * 3 or more fractures within the previous 2 years, or * 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or * 2 or more prevalent vertebral fractures. Exclusion Criteria: Disease Related * History of an electrophoresis pattern inconsistent with type I, III or IV OI. * History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease. * History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.

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Conditions

The condition(s) this trial relates to.

osteogenesis imperfecta

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteogenesis imperfecta

Contacts and locations

Locations

  • Boston Childrens Hospital

    Boston, Massachusetts, 02115, United States

  • Centermed Krakow Sp zoo

    Krakow, 31-530, Poland

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, 59037, France

  • Centre Hospitalier Universitaire Sainte Justine

    Montreal, Quebec, H3T 1C5, Canada

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 1011, Switzerland

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

    Bordeaux, 33076, France

  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

    Verona, 37134, Italy

  • Centrum Medyczne Medyk Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa

    Rzeszów, 35-326, Poland

  • Childrens Hospital of Alabama

    Birmingham, Alabama, 35233, United States

  • Childrens Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1, Canada

  • Childrens Hospital of Soochow University

    Suzhou, Jiangsu, 215000, China

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100, Turkey (Türkiye)

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06500, Turkey (Türkiye)

  • Gillette Childrens Hospital and Clinic Saint Paul

    Saint Paul, Minnesota, 55101, United States

  • Hopital Necker Enfants Malades

    Paris, 75743, France

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, Catalonia, 08950, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, Valencia, 46026, Spain

  • Hospital Universitario Infantil Niño Jesus

    Madrid, 28009, Spain

  • Hospital Universitario de Getafe

    Getafe, Madrid, 28905, Spain

  • Hospital de Cruces

    Barakaldo, Basque Country, 48903, Spain

  • IRCCS Istituto Giannina Gaslini

    Genova, 16147, Italy

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Karadeniz Teknik Universitesi Tip Fakultesi

    Trabzon, 61080, Turkey (Türkiye)

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21287, United States

  • Kepler Universitaetsklinikum GmbH

    Linz, 4020, Austria

  • King Faisal Specialist Hospital and Research Centre

    Riyadh, 11564, Saudi Arabia

  • Marmara Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34890, Turkey (Türkiye)

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449, United States

  • Mayo Clinic Childrens Center

    Rochester, Minnesota, 55905, United States

  • Monash Childrens Hospital

    Clayton, Victoria, 3168, Australia

  • Narodny ustav detskych chorob

    Bratislava, 833 40, Slovakia

  • National Center for Child Health and Development

    Setagaya-ku, Tokyo, 157-8535, Japan

  • Nemours Childrens Hospital

    Orlando, Florida, 32827, United States

  • Nemours Hospital for Children

    Wilmington, Delaware, 19803, United States

  • Okayama Saiseikai Outpatient Center Hospital

    Okayama, Okayama-ken, 700-0013, Japan

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558, Japan

  • Osaka Womens and Childrens Hospital

    Izumi-shi, Osaka, 594-1101, Japan

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730, China

  • Perth Childrens Hospital

    Nedlands, Western Australia, 6909, Australia

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016, United States

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Royal Manchester Childrens Hospital

    Manchester, M13 9WL, United Kingdom

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny UMeds

    Lodz, 91-738, Poland

  • Semmelweis Egyetem

    Budapest, 1094, Hungary

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021, China

  • Shanghai Sixth Peoples Hospital

    Shanghai, 200233, China

  • Sheffield Childrens Hospital

    Sheffield, S10 2TH, United Kingdom

  • Szpital Miejski w Tychach Spolka z ograniczona odpowiedzialnoscia

    Tychy, 43-100, Poland

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053, China

  • Tokyo Metropolitan Children's Medical Center

    Fuchu-shi, Tokyo, 183-8561, Japan

  • Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Tottori University Hospital

    Yonago-shi, Tottori, 683-8504, Japan

  • Universitaets-Kinderspital beider Basel

    Basel, 4031, Switzerland

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Wuerzburg

    Würzburg, 97074, Germany

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • University of California, Los Angeles Interventional Clinical Trials

    Los Angeles, California, 90095, United States

  • University of South Florida - Carol and Frank Morsani Center for Advanced Health Care

    Tampa, Florida, 33606, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212-3157, United States

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610044, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.