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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Recruitment Status : Withdrawn (While the clinical need for and the scientific merit remain valid, this regulated drug trial was not feasible logistically due to limited funds.)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

Tracking Information
First Submitted Date  ICMJE December 15, 2015
First Posted Date  ICMJE December 17, 2015
Last Update Posted Date August 22, 2018
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
Official Title  ICMJE Intravenous Zoledronic Acid for the Treatment of Osteoporosis and Osteonecrosis in Children With Leukemia: A Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Osteonecrosis
  • Acute Lymphoblastic Leukemia
Intervention  ICMJE Drug: Zoledronic acid
Study Arms  ICMJE Experimental: Intravenous Zoledronic Acid
Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months
Intervention: Drug: Zoledronic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 10, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2015)
4
Actual Study Completion Date  ICMJE August 20, 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02632903
Other Study ID Numbers  ICMJE ZA8DEC2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Dr. Leanne Ward, Children's Hospital of Eastern Ontario
Study Sponsor  ICMJE Children's Hospital of Eastern Ontario
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Children's Hospital of Eastern Ontario
Verification Date August 2018

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