Clinical trials: Bone Formation
Osteogenesis Imperfecta, Osteoporosis
Bisphosphonate Therapy for Osteogenesis Imperfecta
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral…
- Conditions
- Osteogenesis Imperfecta, Osteoporosis, Paget Disease of Bone
- Trial name
- NCT00159419
- Testing
- Alendronate, Pamidronate
- Volunteers
- 18 people
- Sponsor
- Indiana University
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
Achondroplasia
A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia
This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of…
- Trial name
- PROPEL3 (NCT06164951)
- Testing
- Infigratinib 0.25 mg/kg/day
- Where
- 27 sites in United States, Argentina and 8 more
- Volunteers
- 114 people
- Sponsor
- QED Therapeutics, a BridgeBio company
Limb Length Discrepancy
Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
- Trial name
- PINS (NCT01601301)
- Testing
- PRECICE System
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Ellipse Technologies, 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
Brittle Bone Disease
Preventive Fixation of Lower Limbs in Osteogenesis Imperfecta (Brittle Bone Disease) With the Highlight of the Fassier-Duval
Osteogenesis imperfecta (or brittle bone disease) is a rare genetic disease characterized by fragile bone and a low mass ossue, secondary to abnormal collagen synthesis. This is a real congenital osteoporosis.
- Trial name
- Fassier-Duval (NCT02868294)
- Testing
- Fassier-Duval Nail
- Where
- France
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Assistance Publique Hopitaux De Marseille
Nonunion Fractures
Treatment of Non Union of Long Bone Fractures by Autologous Mesenchymal Stem Cell
Treatment of nonunion, delayed union and malunion fractures of long bones remains problematic. The definition of nonunion is a failure of the fracture to heal in six months in a patient in whom progressive repair had not been…
- Trial name
- NCT01206179
- Testing
- cell injection
- Where
- Iran
- Volunteers
- 6 people
- Sponsor
- Royan Institute
Osteogenesis Imperfecta Type II, Osteogenesis Imperfecta Type III
Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis Imperfecta
This is a study to evaluate the safety and effectiveness of repeated Mesenchymal Stromal Cells (MSC) infusions to patients with Type II or III osteogenesis imperfecta (OI).
- Trial name
- STOD3 (NCT01061099)
- Testing
- Mesenchymal Stromal Cells
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Nationwide Children's Hospital
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
Osteoporosis, Cerebral Palsy
Prevention of Post Operative Bone Loss in Children
Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density Plan: children with chronic disease such as CP, spina bifida, etc.
- Conditions
- Osteoporosis, Cerebral Palsy, Spina Bifida, Osteopenia
- Trial name
- NCT00655681
- Testing
- pamidronate, saline
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of New Mexico
Duchenne / Becker Muscular Dystrophy, Osteogenesis Imperfecta (OI)
Social Cognition in Dystrophinopathies and Neurodevelopmental Disorders
The primary aim of this observational study is to investigate specific aspects of social cognition in dystrophinopathies. Body awareness, interpersonal distance and emotional processing will be measured in a sample of patients…
- Conditions
- Duchenne / Becker Muscular Dystrophy, Osteogenesis Imperfecta (OI), Social Cognition
- Trial name
- NCT06874166
- Testing
- Electroencephalography (EEG), Social Cognition Tasks
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- IRCCS Eugenio Medea
Osteodysplasia
Stromal Therapy of Osteodysplasia After Allogeneic Bone Marrow Transplantation
Osteodysplasia or poorly formed bones, "brittle bones" is a genetic disease with no known proven treatments. Some forms of osteodysplasia may cause severe disability and even death.
- Trial name
- NCT00186914
- Testing
- Marrow stromal cell infusion
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- St. Jude Children's Research Hospital
Bone Disease, Metabolic
Diagnosis of Osteogenesis Imperfecta in Children
The study will be conducted at Assiut university children hospital and it will include patients with history of repeated fractures due to mild or irrelevant trauma.
- Trial name
- NCT03169192
- Testing
- Zoledronic Acid
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Assiut University
Bilateral or Unilateral Deficient Ramus-condyle Unit
Transport Distraction Osteogenesis for Ramus-Condyle Unit
this study was done to evaluate the use of transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with unilateral or bilateral TMJ ankylosis to correct the resultant deformity
- Trial name
- NCT04383964
- Testing
- Distraction Osteogenesis for Reconstruction of Ramus-Condyle
- Where
- Egypt
- Volunteers
- 10 people
- Sponsor
- Hams Hamed Abdelrahman
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Osteogenesis Imperfecta
Audio-vestibular Evaluation of Children and Young Adults With Osteogenesis Imperfecta
The aim is to determine whether vestibular deficits are present in OI, then to establish whether a correlation exists between genetic type, severity of OI and audiovestibular phenotype.
- Trial name
- AVOI (NCT05419960)
- Testing
- Vestibular Assessment, Petrous bone Computed Tomography (CT), Magnetic Resonance Imaging (MRI)
- Where
- France
- Volunteers
- 44 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Osteogenesis Imperfecta
Pamidronate to Treat Osteogenesis Imperfecta in Children
This study will evaluate the effect of pamidronate a drug that decreases bone resorption (breakdown) on osteogenesis imperfecta. This is a genetic disorder of collagen, the major protein in bone.
- Trial name
- NCT00005901
- Testing
- Pamidronate (Aredia)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Osteoporosis, Osteopenia
Encouraging Calcium Absorption and Bone Formation During Early Puberty
Increasing bone mass during puberty can ultimately decrease the risk of developing osteoporosis, which causes bones to weaken and break more easily later in life.
- Trial name
- NCT00022867
- Testing
- Nondigestible oligosaccharide (NDO)
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Baylor College of Medicine
Fibrodysplasia Ossificans Progressiva
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects
Fibrodysplasia ossificans progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) that result in abnormal bone formation in muscles, tendons, and…
- Trial name
- NCT02190747
- Testing
- Palovarotene
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Clementia Pharmaceuticals Inc.
Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency
Auditory Brainstem Implantation in Young Children
To purpose of this feasibility study is to demonstrate the safety and efficacy of the Nucleus 24 Multichannel Auditory Brainstem Implant (ABI, Cochlear Corp, Sydney, AUS) in children without the diagnosis of neurofibromatosis…
- Conditions
- Developmental Cochlear Nerve Deficiency, Acquired Cochlear Nerve Deficiency, Cochlear Aplasia, Post-meningitis Cochlear Ossification
- Trial name
- NCT01904448
- Testing
- Auditory Brainstem Implantation in Children
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of North Carolina, Chapel Hill