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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Francis H. Glorieux, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00982124
First received: September 21, 2009
Last updated: June 4, 2013
Last verified: June 2013

September 21, 2009
June 4, 2013
October 2007
May 2015   (final data collection date for primary outcome measure)
The primary objective of this trial is to assess the change in lumbar spine bone mineral density Z-score at month 24 relative to baseline in zoledronic acid treated infants compared to historical controls. [ Time Frame: 3 times during 10 visits within 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00982124 on ClinicalTrials.gov Archive Site
To assess the effect of zoledronic acid on the number of clinical fractures &/or vertebral compressions that occur over a two year period compared to untreated historical controls in infants. [ Time Frame: 3 times during 10 visits within 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta
An International, Multicenter, Open-label, Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Osteogenesis Imperfecta
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).
Other Name: Aclasta
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants, male or female 2 weeks to <12 months of age, at least at 38 weeks gestational age.
  • Any child with phenotypic OI type II, III or IV.
  • No previous treatment with bisphosphonate.
  • Negative urine protein as measured by dipstick. One repeat assessment of the urine protein will be allowed. The assessment will be made 2 weeks after the first assessment and the sample must be a urine collection after a 4 hour fast.

Exclusion Criteria:

  • Blood oxygen saturation of less than 90% in room air.
  • Serum creatinine level greater than 56 µmol/L.
  • Any clinically significant clinical laboratory abnormalities at screening.
  • Treatment with any investigational drug within the past 30 days.
  • Patients who are unlikely to be able to complete the study or to comply with the visit schedule.
  • Any disease or planned therapy which will interfere with the procedures or data collection of this trial.
Both
up to 12 Months
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00982124
SHC-INFOI, IRB - A06-M73-06A, Health Canada - 9427-S1926-24C
Not Provided
Francis H. Glorieux, Shriners Hospitals for Children
Shriners Hospitals for Children
Novartis
Principal Investigator: Francis H. Glorieux, MD, PhD McGill University
Shriners Hospitals for Children
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP