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

Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00131118

Enrollment

127

Registered

2005-08-17

Start date

2004-07-31

Completion date

2007-05-31

Last updated

2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteogenesis Imperfecta

Keywords

Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children

Brief 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.

Interventions

DRUGZoledronic Acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

Inclusion criteria

* Have completed the core CZOL446H2202 study * Males or females between 1-17 years of age

Exclusion criteria

* Deformity or abnormality which would prevent spine bone density from being done * Any surgical bone-lengthening procedure * Any kidney diseases or abnormalities * Low calcium or vitamin D levels in the blood Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202	—

Secondary

Measure	Time frame
Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026