Bisphosphonate Treatment of Osteogenesis Imperfecta

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Novartis

Status and phase

Completed
Phase 2

Conditions

Osteogenesis Imperfecta

Treatments

Drug: Zoledronic Acid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00063479
CZOL446H2202

Details and patient eligibility

About

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.

Sex

All

Ages

3 months to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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