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

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ClinicalTrials.gov Identifier: NCT02632903
Recruitment Status : Withdrawn (While the clinical need for and the scientific merit remain valid, this regulated drug trial was not feasible logistically due to limited funds.)
First Posted : December 17, 2015
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Leanne Ward, Children's Hospital of Eastern Ontario

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteonecrosis Acute Lymphoblastic Leukemia Drug: Zoledronic acid Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
Study Start Date : October 2016
Estimated Primary Completion Date : March 2018
Actual Study Completion Date : August 20, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Intravenous Zoledronic Acid
Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months
 Drug: Zoledronic acid


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632903


Locations
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Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
More Information
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Responsible Party: Dr. Leanne Ward, MD, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02632903    
Other Study ID Numbers: ZA8DEC2015
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Osteoporosis
Osteonecrosis
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Necrosis
Pathologic Processes
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs