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

Phase 2

Withdrawn

• Conditions: Osteonecrosis; Acute Lymphoblastic Leukemia; Osteoporosis
• Interventions: Drug: Zoledronic acid

• Registration Number: NCT02632903
• Lead Sponsor: Children's Hospital of Eastern Ontario

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 available

Study Timeline

• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-17
• Study Start: 2016-10
• Primary Completion: 2018-03
• Status Verified: 2018-08
• Study Completion: 2018-08-20
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous Zoledronic Acid	Zoledronic acid	Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months

Primary Outcome Measures

Name	Time	Method
To assess the effect of zoledronic acid on preventing incident vertebral fractures	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.

Trial Locations

Locations (1)

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada