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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02632903
Other study ID # ZA8DEC2015
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date October 2016
Est. completion date August 20, 2018

Study information

Verified date August 2018
Source Children's Hospital of Eastern Ontario
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 20, 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 8 Years to 16 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Zoledronic acid


Locations

Country Name City State
Canada Children's Hospital of Eastern Ontario Ottawa Ontario

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 15 months post-diagnosis (12 months after baseline visit)
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