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

NCT02632903 | Withdrawn Phase 2 DMC

• 1 other identifier: ZA8DEC2015
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Osteonecrosis; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Intravenous Zoledronic Acid

EXPERIMENTAL

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

Drug: Zoledronic acid

Interventions

Zoledronic acid DRUG

Intravenous Zoledronic Acid

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject or subject's legally acceptable representative has provided informed consent.
• Children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (ALL).
• Children with vertebral fractures or osteonecrotic lesions according to the following criteria:
• 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
• 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).

You may not qualify if:

• Any child for whom the treating physician feels participation is not advised.
• Prior treatment with an osteoporosis agent (e.g. bisphosphonate).
• Co-morbidities affecting musculoskeletal health (e.g. cerebral palsy).
• Children with renal failure (eGFR\<60ml/min/1.73m2).
• Children with untreated vitamin D deficiency (vitamin D \<50nmol/L).
• Children with hypocalcemia.
• Children planning dental procedures and/or dental surgery during the course of the study.
• Children with asthma who are acetylsalicylic acid (ASA) sensitive.
• Children with a documented history of atrial fibrillation.
• Currently pregnant or planning a pregnancy during the study.
• Currently breastfeeding or planning on breastfeeding during the study.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Osteoporosis; Osteonecrosis; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: August 20, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)