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Completed

NCT Number: NCT00982124

An 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.

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Key information

Conditions

Osteogenesis Imperfecta Bone Diseases Bone Diseases, Developmental Collagen Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias Skin and Connective Tissue Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shriners Hospital for Children

Montreal, Quebec, H4A0A9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children, 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.
  • Any child classified as OI type I, V-VIII that has had at least two or more previous fractures of long bone, or vertebral compression fractures, and a low bone mineral density.
  • No previous treatment with bisphosphonates.
  • Negative urine protein as measured by dipstick. One repeat assessment of the urine protein will be allowed.

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 comply with the visit schedule.
  • Any disease or planned therapy which will interfere with the procedures or data collection of this trial.

Treatment and study plan

Zoledronic acid

Drug

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 names: Aclasta

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Shriners Hospitals for Children

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Acronym: INFOI

Important dates

Study start
2007
Primary completion
2015
Study completion
2016
First posted
Sep 22, 2009
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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