Back to resultsIntravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
Primary Purpose
Osteoporosis, Osteonecrosis, Acute Lymphoblastic Leukemia
Status
Withdrawn
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Subject or subject's legally acceptable representative has provided informed consent.
- Children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (ALL).
Children with vertebral fractures or osteonecrotic lesions according to the following criteria:
- 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
- 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:
- Any child for whom the treating physician feels participation is not advised.
- Prior treatment with an osteoporosis agent (e.g. bisphosphonate).
- Co-morbidities affecting musculoskeletal health (e.g. cerebral palsy).
- Children with renal failure (eGFR<60ml/min/1.73m2).
- Children with untreated vitamin D deficiency (vitamin D <50nmol/L).
- Children with hypocalcemia.
- Children planning dental procedures and/or dental surgery during the course of the study.
- Children with asthma who are acetylsalicylic acid (ASA) sensitive.
- Children with a documented history of atrial fibrillation.
- Currently pregnant or planning a pregnancy during the study.
- Currently breastfeeding or planning on breastfeeding during the study.
Sites / Locations
- Children's Hospital of Eastern Ontario
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intravenous Zoledronic Acid
Arm Description
Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months
Outcomes
Primary Outcome Measures
To assess the effect of zoledronic acid on preventing incident vertebral fractures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02632903
First Posted
December 15, 2015
Last Updated
August 20, 2018
Sponsor
Children's Hospital of Eastern Ontario
1. Study Identification
Unique Protocol Identification Number
NCT02632903
Brief Title
Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
Official Title
Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
While the clinical need for and the scientific merit remain valid, this regulated drug trial was not feasible logistically due to limited funds.
Study Start Date
October 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
August 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteonecrosis, Acute Lymphoblastic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous Zoledronic Acid
Arm Type
Experimental
Arm Description
Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Primary Outcome Measure Information:
Title
To assess the effect of zoledronic acid on preventing incident vertebral fractures
Description
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.
Time Frame
15 months post-diagnosis (12 months after baseline visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject or subject's legally acceptable representative has provided informed consent.
Children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (ALL).
Children with vertebral fractures or osteonecrotic lesions according to the following criteria:
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
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:
Any child for whom the treating physician feels participation is not advised.
Prior treatment with an osteoporosis agent (e.g. bisphosphonate).
Co-morbidities affecting musculoskeletal health (e.g. cerebral palsy).
Children with renal failure (eGFR<60ml/min/1.73m2).
Children with untreated vitamin D deficiency (vitamin D <50nmol/L).
Children with hypocalcemia.
Children planning dental procedures and/or dental surgery during the course of the study.
Children with asthma who are acetylsalicylic acid (ASA) sensitive.
Children with a documented history of atrial fibrillation.
Currently pregnant or planning a pregnancy during the study.
Currently breastfeeding or planning on breastfeeding during the study.
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
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