An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta

2014-07-23 21:12:42 | BioPortfolio


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 to severe forms of Osteogenesis Imperfecta (OI). This trial has included only children above one year of age. The aim of the current study is to extend the observations of that currently finished study to infants below 1 year of age. Moreover, it is possible to administer zoledronate in a single short infusion instead of the three-day cycles with Pamidronate, therefore decreasing patient and family burdens with shorter stays in the hospital.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Osteogenesis Imperfecta


Zoledronic Acid


Shriners Hospital for Children
H3G 1A6




Shriners Hospitals for Children

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:12:42-0400

Clinical Trials [1074 Associated Clinical Trials listed on BioPortfolio]

Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

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.

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. Diagnosis will be esta...

Pregnancy in Osteogenesis Imperfecta (OI) Registry

The purpose of this study is to learn about pregnancy outcomes in osteogenesis imperfecta (OI). Patients enrolled in the Brittle Bone Disorders (BBD) Contact Registry (CR) will be invited ...

Open-label Extension Denosumab Study in Children and Young Adults With Osteogenesis Imperfecta

To evaluate long-term safety of denosumab in subjects with pediatric osteogenesis imperfecta(OI) completing Study 20130173.

An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta

The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. ...

PubMed Articles [6757 Associated PubMed Articles listed on BioPortfolio]

Acute and long-term effects of zoledronate in adult patients with osteogenesis imperfecta. An observational Spanish study with five years of follow-up.

Osteogenesis imperfecta (OI) is an inherited disorder that causes low mineral density and bone fragility. Previous studies have shown the efficacy of bisphosphonates to increase bone mineral density (...

Osteogenesis Imperfecta: Muscle-Bone Interactions when Bi-directionally Compromised.

Osteogenesis imperfecta (OI) is a hereditary connective tissue disorder of skeletal fragility and more recently muscle weakness. This review highlights our current knowledge of the impact of compromis...

Gamma knife radiosurgery for trigeminal neuralgia associated with osteogenesis imperfecta.

Trigeminal neuralgia is a rare feature of basilar impression, a complication of osteochondrodysplastic disorders. Microvascular decompression is difficult in medically refractory cases. Gamma knife ra...

Osteogenesis imperfecta and the teeth, eyes, and ears-a study of non-skeletal phenotypes in adults.

Osteogenesis imperfecta (OI) is a disease causing bone fragility; however, it potentially affects all organs with a high content of collagen, including ears, teeth, and eyes. The study is cross-sectio...

Cumulative radiation exposure from medical imaging and associated lifetime cancer risk in children with osteogenesis imperfecta.

To estimate the cumulative effective dose of radiation (E) and additional lifetime attributable risk (LAR) of cancer from ionizing radiation in children with osteogenesis imperfecta (OI), who require ...

Medical and Biotech [MESH] Definitions

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.

An Sp transcription factor that contains three CYS2-HIS2 ZINC FINGERS. It binds to GC RICH SEQUENCES and performs an essential function in regulating gene expression for differentiation of OSTEOBLASTS. Mutations in the SP7 gene are associated with type 12 OSTEOGENESIS IMPERFECTA.

A clinically and genetically heterogeneous group of hereditary conditions characterized by malformed DENTAL ENAMEL, usually involving DENTAL ENAMEL HYPOPLASIA and/or TOOTH HYPOMINERALIZATION.

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.

The process of bone formation. Histogenesis of bone including ossification.

More From BioPortfolio on "An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta"

Quick Search


Relevant Topic

Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...

Searches Linking to this Trial