Clinical trials: Osteogenesis
Osteoporosis
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
The study is designed as a retrospective, multicenter study for subjects previously treated with the AGN1 LOEP Kit in the proximal femur as part of standard hospital practice. This will be a non-randomized and non-blinded study.
- Trial name
- NCT07594639
- Testing
- AGN1 LOEP
- Where
- Belgium
- Volunteers
- 305 people
- Sponsor
- AgNovos Healthcare, LLC
Connective Tissue Disorders, Osteogenesis Imperfecta
Evaluation and Treatment of Patients With Connective Tissue Disease
This study offers evaluation and treatment of patients with a suspected connective tissue disorder. The protocol is not designed to test new treatments; rather, patients receive standard care.
- Conditions
- Connective Tissue Disorders, Osteogenesis Imperfecta, Bone Diseases, Metabolic, Melorheostosis
- Trial name
- NCT00076830
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Osteogenesis Imperfecta
Setrusumab vs Placebo for Osteogenesis Imperfecta
The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.
- Trial name
- Orbit (NCT05125809)
- Testing
- Setrusumab
- Where
- 43 sites in United States, Australia and 9 more
- Volunteers
- 183 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Osteogenesis Imperfecta
Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.
- Trial name
- Cosmic (NCT05768854)
- Testing
- Bisphosphonate, Setrusumab
- Where
- 20 sites in United States, Brazil and 5 more
- Volunteers
- 69 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Osteogenesis Imperfecta
Evaluation and Intervention for the Effects of Osteogenesis Imperfecta
We propose a longitudinal study of the natural history of types III and IV osteogenesis imperfecta for children age birth to 25 years.
- Trial name
- NCT00001594
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Osteogenesis Imperfecta, Short Stature
Natural History of the Collagen-Related Disorder Osteogenesis Imperfecta and Genotype Phenotype Correlation
Background: Osteogenesis Imperfecta (OI) is a connective tissue disorder. OI affects many aspects of a person s health and growth. It can cause frequent fractures, short stature, and bowing of the long bones.
- Trial name
- NCT03575221
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Osteogenesis Imperfecta
Setrusumab in Pediatric Japanese Subjects With Osteogenesis Imperfecta
The primary objective of the study is to evaluate the effect of setrusumab on reduction in fracture rate, including morphometric vertebral fractures.
- Trial name
- NCT06636071
- Testing
- setrusumab
- Where
- 3 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Osteogenesis Imperfecta (OI)
A Dose REgimen-Finding Study of AGA2115 in Chinese Patients With Osteogenesis ImpeRfecta (EIR)
This study is to evaluate the safety and efficacy of AGA2115 at three different dose regimens in Chinese adults and adolescents with Type I, III, or IV Osteogenesis imperfecta (OI).
- Trial name
- EIR (NCT07557446)
- Testing
- AGA2115
- Where
- 5 sites in China
- Volunteers
- 48 people
- Sponsor
- Angitia Biopharmaceuticals Guangzhou Limited
Osteogenesis Imperfecta
BBD Longitudinal Study of Osteogenesis Imperfecta
Osteogenesis Imperfecta (OI) is a rare disorder of increased bone fragility characterized by fractures with minimal or absent trauma, dentinogenesis imperfecta (DI), and, in adult years, hearing loss.
- Trial name
- NCT02432625
- Where
- 12 sites in United States, Canada
- Volunteers
- 1,000 people
- Sponsor
- Baylor College of Medicine
Osteogenesis Imperfecta
Clear Aligners for the Treatment of Dental Malocclusion in OI
Misalignment of teeth and jaws (also called malocclusion) is a common life altering problem facing many individuals with Osteogenesis Imperfecta (OI).
- Trial name
- NCT04815564
- Testing
- Invisalign
- Where
- 3 sites in United States, Canada
- Volunteers
- 57 people
- Sponsor
- Baylor College of Medicine
Osteogenesis Imperfecta
Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product…
- Trial name
- NCT07366086
- Testing
- Vitamin D, Calcium
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 71 people
- Sponsor
- Amgen
Osteogenesis Imperfecta
Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
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…
- Trial name
- NCT05972551
- Testing
- Romosozumab, Bisphosphonate
- Where
- 65 sites in United States, Australia and 16 more
- Volunteers
- 111 people
- Sponsor
- Amgen
Osteogenesis Imperfecta
Increasing Knowledge on Osteogenesis Imperfecta by Collecting Epidemiological Data
interventional pilot study with the enrollment of patients affected by Osteogenesis Imperfecta
- Trial name
- 4FRAILTY (NCT06193642)
- Testing
- experimental
- Where
- Italy
- Volunteers
- 33 people
- Sponsor
- Istituto Ortopedico Rizzoli
Osteogenesis Imperfecta, Osteogenesis Imperfecta Type III
Mesenchymal Cell Therapy in Osteogenesis Imperfecta (OI)
This is a Phase 1/2 study to determine the safety and efficacy of allogeneic (third party), bone-marrow derived mesenchymal stromal cells (MSCs) for the treatment of Osteogenesis Imperfecta (OI) Type 3.
- Trial name
- NCT05559801
- Testing
- Bone marrow-derived mesenchymal stromal cells (MSCs)
- Volunteers
- 12 people
- Sponsor
- Emory University
Osteogenesis Imperfecta
Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Osteogenesis Imperfecta
This research study aims to evaluate the effect of a 6-month adapted physical activity program (APA) on the endurance capacities (evaluated as the maximum oxygen consumption [VO2 peak]) of children and adolescents with…
- Trial name
- BONeMOVE (NCT05927389)
- Testing
- Adapted Physical Activity program
- Where
- 2 sites in France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Toulouse
Osteogenesis Imperfecta
Effects of Bisphosphonates on OI-Related Hearing Loss
Osteogenesis Imperfecta-related hearing loss usually occurs in individuals with mild (type I) OI and is much earlier in onset than age-related hearing loss, with the majority of individuals experiencing some minor hearing loss in…
- Trial name
- NCT04152551
- Testing
- Risedronate Oral Tablet
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hospital for Special Surgery, New York
Osteogenesis Imperfecta, Osteoporosis
REMS25: Study on the Use of REMS Technology in Diseases Commonly Associated With Reduced Bone Mineral Density (BMD)
This study evaluates bone mineral density (BMD) in pediatric patients aged 5-18 years with conditions negatively affecting bone health, using REMS (Radiofrequency Echographic Multi Spectrometry), a non-invasive and radiation-free…
- Conditions
- Osteogenesis Imperfecta, Osteoporosis, Hypogonadisms, Neoplasia
- Trial name
- NCT07412782
- Testing
- REMS
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Meyer Children's Hospital IRCCS
Osteogenesis Imperfecta
Dental Malocclusion and Craniofacial Development in OI
Osteogenesis imperfecta (OI) is a rare inherited disorder that causes bones to break easily. Individuals with osteogenesis imperfecta break bones often and may have other problems, including hearing loss and pain and difficulty…
- Trial name
- NCT02934451
- Where
- 3 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- Baylor College of Medicine
Osteogenesis Imperfecta
Post-market Observational Study on JTIN Telescopic Nail in Osteogenesis Imperfecta Pediatric Patients
This study has been planned as part of the Orthofix Srl post-market active surveillance plan for the collection of data on both the clinical performance and the safety profile of the JTIN.
- Trial name
- JTIN (NCT05612139)
- Testing
- JTIN implantation surgery
- Where
- France
- Volunteers
- 14 people
- Sponsor
- Orthofix s.r.l.
Osteogenesis Imperfecta (OI), Osteogenesis Imperfecta
Prospective Observational Cohort Study of Cardiac Structure and Function in Children and Adults With Osteogenesis Imperfecta
This prospective observational investigation will examine the incidence and progression of cardiologic findings in individuals with OI across different age groups.
- Trial name
- OI Cardio (NCT07287241)
- Testing
- Imaging evaluation, Echocardiography
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- Istituto Ortopedico Rizzoli