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

PHASE3CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

September 30, 2015

Study Completion Date

April 30, 2016

Conditions
Osteogenesis Imperfecta
Interventions
DRUG

Zoledronic Acid

Each patient is to receive an initial dose of zoledronic acid of 0.0125 mg per kg body weight, then subsequent doses of zoledronic acid at a dose of 0.025 mg per kg body weight once every 12 to 13 weeks for 104 weeks (total of 8 doses).

Trial Locations (1)

H4A0A9

Shriners Hospital for Children, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Shriners Hospitals for Children

OTHER

NCT00982124 - An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta | Biotech Hunter | Biotech Hunter