Osteoporosis in Children With ALL
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00330538 |
Recruitment Status :
Completed
First Posted : May 29, 2006
Last Update Posted : April 6, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Hypothesis:
Pediatric patients with acute lymphoblastic leukemia, treated with chronic glucocorticoids as a part of the leukemia treatment protocol, will have an increased incidence and severity of osteoporosis.
Condition or disease |
---|
Leukemia, Lymphocytic, Acute, L1 |
Osteoporosis is a disease characterized by low bone mass and microarchitectural deterioration of bone tissue. Osteoporosis is a devastating disorder with significant physical, psychosocial and financial consequences. Intensive chemotherapy and radiotherapy have led to significant improvements in long term, disease-free survival of children with malignancies. Unfortunately, there are many deleterious side effects associated with this therapy. Little is known about the longitudinal changes in bone mass accumulation and bone metabolism in these patients.
The purpose of this study is to evaluate the timing and severity of changes in bone mineral metabolism for children treated for childhood leukemia. Data will be used to establish treatment protocols with the goal of preventing severe fractures and pain in the acute treatment stage and severe osteoporosis and related pathology in the chronic stage.
Study Type : | Observational |
Enrollment : | 20 participants |
Observational Model: | Defined Population |
Time Perspective: | Prospective |
Official Title: | Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy |
Study Start Date : | March 2004 |
Actual Study Completion Date : | October 2006 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 4 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All pediatric patients with a new diagnosis of ALL between ages 4-18
- Patients who are expected to receive glucocorticoids as part of the leukemia treatment protocol
- Bone density measurements must be performed at the diagnosis visit or maximally within 48 hours after the first dose of glucocorticoids
Exclusion Criteria:
- Patients under 4 years of age are excluded due to lack of age appropriate standards for bone mineral density
- Glucocorticoid therapy of at least one month or longer within the six months prior to DX
- History of connective tissue or musculoskeletal disorders
- Biphosphonate therapy within the past 6 months
- Acute renal failure
- Serum creatinine equal to or higher than 4.5mg/dl
- Positive serum pregnancy test in adolescent females

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330538
United States, Missouri | |
Children's Mercy Hospital | |
Kansas City, Missouri, United States, 64108 |
Principal Investigator: | Jadranka Popovic, MD | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00330538 |
Other Study ID Numbers: |
03 08-085 |
First Posted: | May 29, 2006 Key Record Dates |
Last Update Posted: | April 6, 2007 |
Last Verified: | April 2007 |
Osteoporosis Childhood acute lymphoblastic leukemia |
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Osteoporosis Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |