Actively Recruiting
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
Led by Amgen · Updated on 2026-05-01
106
Participants Needed
65
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.
CONDITIONS
Official Title
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has provided informed consent or assent prior to any study activities
- Legally authorized representative has provided consent for participants too young, with participant assent as required
- Ambulatory male and female children and adolescents aged 5 to less than 18 years, including those ambulatory with assistance
- Clinical diagnosis of osteogenesis imperfecta types I, III, or IV based on clinical history and phenotype
- If familial, OI must be autosomal dominant
- Must have either 3 or more fractures in the past 2 years, or 1 or more nonvertebral fracture plus at least 1 vertebral fracture in the past 2 years, or 2 or more prevalent vertebral fractures
You will not qualify if you...
- Electrophoresis pattern not consistent with type I, III, or IV osteogenesis imperfecta
- Known mutation in a gene other than collagen type I alpha 1 or alpha 2 causing OI or other metabolic bone disease
- History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 65 locations
1
Childrens Hospital of Alabama
Birmingham, Alabama, United States, 35233
Terminated
2
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
University of California, Los Angeles Interventional Clinical Trials
Los Angeles, California, United States, 90095
Actively Recruiting
4
Nemours Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
5
Nemours Childrens Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
6
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
Tampa, Florida, United States, 33606
Actively Recruiting
7
Emory University
Atlanta, Georgia, United States, 30322
Terminated
8
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
9
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
Mayo Clinic Childrens Center
Rochester, Minnesota, United States, 55905
Terminated
12
Gillette Childrens Hospital and Clinic Saint Paul
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
13
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-3157
Actively Recruiting
14
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
15
Monash Childrens Hospital
Clayton, Victoria, Australia, 3168
Actively Recruiting
16
Perth Childrens Hospital
Nedlands, Western Australia, Australia, 6909
Actively Recruiting
17
Kepler Universitaetsklinikum GmbH
Linz, Austria, 4020
Actively Recruiting
18
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Actively Recruiting
19
Childrens Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
20
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
21
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
22
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
23
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China, 518053
Actively Recruiting
24
Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
25
Childrens Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
26
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
27
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Actively Recruiting
28
West China Hospital Sichuan University
Chengdu, Sichuan, China, 610044
Actively Recruiting
29
Shanghai Sixth Peoples Hospital
Shanghai, China, 200233
Actively Recruiting
30
Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin
Bordeaux, France, 33076
Actively Recruiting
31
Centre Hospitalier Regional Universitaire de Lille
Lille, France, 59037
Actively Recruiting
32
Hopital Necker Enfants Malades
Paris, France, 75743
Actively Recruiting
33
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
34
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97074
Actively Recruiting
35
Semmelweis Egyetem
Budapest, Hungary, 1094
Actively Recruiting
36
IRCCS Istituto Giannina Gaslini
Genova, Italy, 16147
Actively Recruiting
37
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona, Italy, 37134
Actively Recruiting
38
Okayama Saiseikai Outpatient Center Hospital
Okayama, Okayama-ken, Japan, 700-0013
Actively Recruiting
39
Okayama University Hospital
Okayama, Okayama-ken, Japan, 700-8558
Actively Recruiting
40
Osaka Womens and Childrens Hospital
Izumi-shi, Osaka, Japan, 594-1101
Actively Recruiting
41
Tokyo Metropolitan Children's Medical Center
Fuchu-shi, Tokyo, Japan, 183-8561
Actively Recruiting
42
National Center for Child Health and Development
Setagaya-ku, Tokyo, Japan, 157-8535
Actively Recruiting
43
Tottori University Hospital
Yonago-shi, Tottori, Japan, 683-8504
Actively Recruiting
44
Centermed Krakow Sp zoo
Krakow, Poland, 31-530
Actively Recruiting
45
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny UMeds
Lodz, Poland, 91-738
Actively Recruiting
46
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland, 93-338
Actively Recruiting
47
Centrum Medyczne Medyk Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
Rzeszów, Poland, 35-326
Actively Recruiting
48
Szpital Miejski w Tychach Spolka z ograniczona odpowiedzialnoscia
Tychy, Poland, 43-100
Actively Recruiting
49
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia, 11564
Actively Recruiting
50
Narodny ustav detskych chorob
Bratislava, Slovakia, 833 40
Actively Recruiting
51
Hospital de Cruces
Barakaldo, Basque Country, Spain, 48903
Actively Recruiting
52
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
53
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain, 08950
Actively Recruiting
54
Hospital Universitario de Getafe
Getafe, Madrid, Spain, 28905
Actively Recruiting
55
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
56
Hospital Universitario Infantil Niño Jesus
Madrid, Spain, 28009
Actively Recruiting
57
Universitaets-Kinderspital beider Basel
Basel, Switzerland, 4031
Actively Recruiting
58
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, 1011
Actively Recruiting
59
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi
Ankara, Turkey (Türkiye), 06500
Actively Recruiting
60
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye), 34890
Actively Recruiting
61
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
62
Karadeniz Teknik Universitesi Tip Fakultesi
Trabzon, Turkey (Türkiye), 61080
Actively Recruiting
63
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
64
Royal Manchester Childrens Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
65
Sheffield Childrens Hospital
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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