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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-08-20

Brief Summary

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This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.

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Detailed Description

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Conditions

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Osteoporosis Osteonecrosis Acute Lymphoblastic Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous Zoledronic Acid

Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Interventions

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Zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No