Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study

August 20, 2018 updated by: Dr. Leanne Ward, Children's Hospital of Eastern Ontario
This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject or subject's legally acceptable representative has provided informed consent.
  2. Children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (ALL).

  3. Children with vertebral fractures or osteonecrotic lesions according to the following criteria:

    1. children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions on MRI of the hips and/or knees identified through routine clinical screening at least 8 weeks following chemotherapy initiation OR
    2. children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions of the hips and/or knees on MRI that are identified at any time in the first 12 months after chemotherapy initiation following presentation with back pain (in the case of vertebral fractures, identified by lateral spine x-rays) and/or hip pain (in the case of osteonecrotic lesions, identified by MRI) and/or knee pain (in the case of osteonecrotic lesions, identified by MRI).

Exclusion Criteria:

  1. Any child for whom the treating physician feels participation is not advised.
  2. Prior treatment with an osteoporosis agent (e.g. bisphosphonate).
  3. Co-morbidities affecting musculoskeletal health (e.g. cerebral palsy).
  4. Children with renal failure (eGFR<60ml/min/1.73m2).
  5. Children with untreated vitamin D deficiency (vitamin D <50nmol/L).
  6. Children with hypocalcemia.
  7. Children planning dental procedures and/or dental surgery during the course of the study.
  8. Children with asthma who are acetylsalicylic acid (ASA) sensitive.
  9. Children with a documented history of atrial fibrillation.
  10. Currently pregnant or planning a pregnancy during the study.
  11. Currently breastfeeding or planning on breastfeeding during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravenous Zoledronic Acid
Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months
Drug: Zoledronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effect of zoledronic acid on preventing incident vertebral fractures
Time Frame: 15 months post-diagnosis (12 months after baseline visit)
To assess the effect of zoledronic acid on preventing incident vertebral fractures as measured by lateral spine radiographs at 15 months post-diagnosis compared to baseline (with baseline occurring 3 months post-diagnosis). An incident vertebral fracture on lateral spine radiographs will be defined as a new fracture (Genant Grade 1 or more) in a previously normal vertebral body, or worsening of an existing fracture (increase in Genant Grade by at least 1) on the follow-up x-ray that takes place 12 months after the first dose.
15 months post-diagnosis (12 months after baseline visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Eastern Ontario

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Actual)

August 20, 2018

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZA8DEC2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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