Not provided
Not provided
Not provided
Not provided
Not provided
While the clinical need for and the scientific merit remain valid, this regulated drug trial was not feasible logistically due to limited funds.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Zoledronic Acid | Experimental | Intravenous Zoledronic Acid 0.025mg/kg at baseline and 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D010020 | Osteonecrosis |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |