Bisphosphonate Treatment of Osteogenesis Imperfecta

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00063479

Enrollment

158

Registered

2003-06-30

Start date

2003-06-30

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, OI, bone markers, fracture, bone loss, pediatric, bisphosphonate, brittle bone disease, pamidronate

Brief summary

The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.

Interventions

DRUGZoledronic Acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 17 Years

Healthy volunteers

Inclusion criteria

Inclusion * Male or Female children between 3 months and 17 years old * OI type I, III or IV Exclusion * 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/

Exclusion criteria

may apply.

Design outcomes

Primary

Measure	Time frame
Change in lumbar spine bone mineral density at month 12 relative to baseline	—

Secondary

Measure	Time frame
Change in Z score of the lumbar spine at month 12 relative to baseline	—

Countries

United States

Outcome results

None listed

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