Actively Recruiting
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Led by Angitia Incorporated Limited · Updated on 2026-04-21
80
Participants Needed
27
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will determine the effect of treatment of AGA2115 in adults with Type I, III, or IV osteogenesis imperfecta versus placebo.
CONDITIONS
Official Title
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 18 to 75 years with osteogenesis imperfecta Type I, III, or IV confirmed by genetic testing of COL1A1 or COL1A2
- Able to provide signed informed consent and comply with study requirements
- Bone mineral density T-score less than or equal to -1.0 at lumbar spine, total hip, or femoral neck
You will not qualify if you...
- Vitamin D deficiency
- Uncontrolled diseases affecting bone metabolism such as thyroid or parathyroid disorders or other endocrine problems
- Current high or low blood calcium levels
- History of rickets, osteomalacia, or other skeletal conditions causing bone deformities or fracture risk (other than osteogenesis imperfecta)
- Use of bisphosphonates within the past 6 months
- Use of teriparatide, abaloparatide, strontium ranelate, or hormone replacement therapy within the past 12 months
- Use of denosumab or its biosimilars within the past 2 years
- Use of anti-sclerostin antibody medications at any time
- History of heart attack, stroke, or significant cardiovascular event within the last 12 months
- Cancer diagnosis within the past 5 years
- Pregnant or breastfeeding women, or women planning pregnancy during the study
- Participation in another clinical study with investigational products within the past 12 months or concurrent enrollment in such studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Phoenix Children's
Phoenix, Arizona, United States, 85016
Not Yet Recruiting
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Not Yet Recruiting
3
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Not Yet Recruiting
4
Indiana University School of Medicine, Department of Medicine and Pediatrics Division of Endocrinology
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States, 63110
Not Yet Recruiting
6
University of Nebraska Medical Center (UNMC) - Diabetes and Endocrinology Center
Omaha, Nebraska, United States, 68131
Not Yet Recruiting
7
New Mexico Clinical Research & Osteoporosis Center, Inc. (NMCROC)
Albuquerque, New Mexico, United States, 87160
Actively Recruiting
8
The Ohio State University Wexner Medical Center (OSUWMC)
Columbus, Ohio, United States, 43210
Not Yet Recruiting
9
Oregon Health & Science University (OHSU) - The Harold Schnitzer Diabetes Health Center (HSDHC) - Endocrinology Clinic
Portland, Oregon, United States, 97239
Not Yet Recruiting
10
Vanderbilt University Medical Center (VUMC) - Eskind Diabetes Clinic
Nashville, Tennessee, United States, 37232
Not Yet Recruiting
11
Instituto de Investigaciones Metabolicas Dr. Zanchetta - Sede Centro
Buenos Aires, Argentina
Not Yet Recruiting
12
Monash University-Monash Medical Centre (MMC)
Melbourne, Australia
Not Yet Recruiting
13
Royal Melbourne Hospital
Parkville, Australia
Not Yet Recruiting
14
Royal North Shore Hospital (RNSH)
Saint Leonards, Australia
Not Yet Recruiting
15
Adults Westmead Hospital
Westmead, Australia
Not Yet Recruiting
16
University Health Network - Toronto General Hospital - Osteoporosis Clinic
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
17
Aarhus Universitetshospital - Medicinsk Endokrinologisk Afdeling (MEA) Ambulatoriet - Tage-Hansens Gade
Aarhus, Denmark
Not Yet Recruiting
18
Odense Universitetshospital
Odense, Denmark
Not Yet Recruiting
19
Hopital Edouard Herriot
Lyon, France
Not Yet Recruiting
20
Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
Paris, France
Not Yet Recruiting
21
Leiden University Medical Center (LUMC) - Centrum voor botkwaliteit
Leiden, Netherlands
Not Yet Recruiting
22
Erasmus MC
Rotterdam, Netherlands
Not Yet Recruiting
23
Isala ziekenhuizen
Zwolle, Netherlands
Not Yet Recruiting
24
Cambridge University Hospitals NHS Foundation Trust-Addenbrooke's Hospital
Cambridge, United Kingdom
Not Yet Recruiting
25
Lothian Health Board, Western General Hospital
Edinburgh, United Kingdom
Not Yet Recruiting
26
Royal National Orthopaedic Hospital NHS Trust
London, United Kingdom
Not Yet Recruiting
27
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Not Yet Recruiting
Research Team
K
Kimberly Brown
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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