Osteogenesis Imperfecta Clinical Trial
Official title:
TRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMAB
Pilot study to assess the efficacy of a therapy with the RANKL-antibody denosumab in
children 5-10 years of age with mutation in COL1A1 or COL1A2 leading to Osteogenesis
imperfecta. Efficacy will be assessed by DXA measurements at the lumbar spine of the areal
bone mineral density (BMD) which is the most frequently used parameter in trials
investigating osteoporosis.
The hypothesis of the study is:
Osteoclastic activity which is increased in OI could be reduced by inhibition of osteoclast
maturation. Denosumab inhibits maturation of the osteoclasts by inhibiting RANKL. BMD could
be increased during a 36 week treatment course with denosumab measured after 48 weeks.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03557567 -
NGS Strategy Effectiveness in Molecular Diagnosis
|
||
Active, not recruiting |
NCT02531087 -
Urinary Biomarkers of OI Pathobiology
|
||
Completed |
NCT01713231 -
Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta
|
Phase 4 | |
Completed |
NCT00655681 -
Prevention of Post Operative Bone Loss in Children
|
N/A | |
Recruiting |
NCT06065111 -
Study of Osteogenesis Imperfecta Tendon
|
||
Withdrawn |
NCT03216486 -
An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
|
Phase 2 | |
Recruiting |
NCT06086613 -
A First-in-Human Study Evaluating AGA2115 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04009733 -
Epigenetic Regulation of Osteogenesis Imperfecta Severity : miROI Study
|
N/A | |
Completed |
NCT04231916 -
High Resolution Thermal Imaging to Identify Vertebral Fractures in Children and Young People With Osteogenesis Imperfecta
|
N/A | |
Active, not recruiting |
NCT02814591 -
Development of a Non-invasive Assessment of Human Bone Quality Using Spatially Offset Raman Spectroscopy
|
||
Completed |
NCT00982124 -
An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta
|
Phase 3 | |
Completed |
NCT00001305 -
Growth Hormone Therapy in Osteogenesis Imperfecta
|
Phase 3 | |
Completed |
NCT04119388 -
Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta
|
N/A | |
Terminated |
NCT01679080 -
The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
|
Phase 2 | |
Completed |
NCT00106028 -
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
|
Phase 3 | |
Recruiting |
NCT04152551 -
Effects of Bisphosphonates on OI-Related Hearing Loss
|
Phase 4 | |
Completed |
NCT00705120 -
Treatment of Severe Osteogenesis Imperfecta by Allogeneic Bone Marrow Transplantation
|
Phase 1 | |
Recruiting |
NCT04169568 -
Osteogenesis Imperfecta Blood Pressure Study
|
||
Completed |
NCT03064074 -
Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta
|
Phase 1 | |
Not yet recruiting |
NCT05258019 -
Site Preservation After Tooth Extraction
|