Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Summary
This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Osteogenesis Imperfecta
Intervention
Zoledronic Acid
Location
UCLA Medical Center-Dept of Pediatric Nephrology
Los Angeles
California
United States
90095
Status
Completed
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00131118
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Osteogenesis Imperfecta
Autosomal dominant COLLAGEN DISEASES resulting from defective biosynthesis of COLLAGEN TYPE I and characterized by brittle, osteoporotic, and easily fractured bones. It may also present with blue sclerae, loose joints, and imperfect dentin formation. There are four major types, I-IV.
Chondrogenesis
The formation of cartilage. This process is directed by CHONDROCYTES which continually divide and lay down matrix during development. It is sometimes a precursor to OSTEOGENESIS.
Amelogenesis Imperfecta
A clinically and genetically heterogeneous group of hereditary conditions characterized by malformed DENTAL ENAMEL, usually involving DENTAL ENAMEL HYPOPLASIA and/or TOOTH HYPOMINERALIZATION.
Osteogenesis
The process of bone formation. Histogenesis of bone including ossification.
Dentinogenesis Imperfecta
An autosomal dominant disorder of tooth development characterized by opalescent dentin resulting in discoloration of the teeth, ranging from dusky blue to brownish. The dentin is poorly formed with an abnormally low mineral content; the pulp canal is obliterated, but the enamel is normal. The teeth usually wear down rapidly, leaving short, brown stumps. (Dorland, 27th ed)
Clinical Trials
The investigators have currently finished conducting an international multi-center trial that compares the efficacy and safety of pamidronate and zoledronate in the treatment of moderate t...
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 ch...
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There are no approved drugs for the treatment of OI in children, even though some intravenous (IV) b...
Neoadjuvant Zoledronic Acid in Patients With Resectable Pancreas Cancer
The overall purpose of this research is to evaluate the safety and side effects of zoledronic acid (also known as Zometa) in patients before they have surgery to remove the cancer.
Marrow Mesenchymal Cell Therapy for Osteogenesis Imperfecta: A Pilot Study
Osteogenesis imperfecta (OI) is a genetic disease for which there is currently no known cure. OI causes the osteoblasts (bone-forming cells in the body) to grow poorly, which slows the gro...
PubMed Articles
Distal patellar tendon avulsion fracture in a football player with osteogenesis imperfecta.
Proximal patellar tendon ruptures have been described in adults with osteogenesis imperfecta, but distal avulsions from the tibial tubercle have not. This is the first case reporting a distal patellar...
New perspectives on osteogenesis imperfecta.
A new paradigm has emerged for osteogenesis imperfecta as a collagen-related disorder. The more prevalent autosomal dominant forms of osteogenesis imperfecta are caused by primary defects in type I co...
The genetic basis for skeletal disease. Osteogenesis imperfecta and genetic abnormalities.
Patients with osteogenesis imperfecta (OI) represent various degrees of bone fragility and accompany many clinical manifestations such as dentinogenesis imperfecta, blue sclera, growth disturbance, he...
Recent Advances in Osteogenesis Imperfecta.
"Osteogenesis imperfecta" is a term used to describe a group of genetic disorders of variable phenotype usually defined by recurrent fractures, low bone mass, and skeletal fragility. Most cases are as...
The genetic basis for skeletal disease. Osteogenesis imperfecta.
Osteogenesis imperfecta (OI) is characterized by its bone fragility. But the spectrum of the severity of the fragility is widely distributed. Recently, amino-bisphosphonate has been introduced into th...
