NCT00330538

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

April 6, 2007

Status Verified

April 1, 2007

First QC Date

May 26, 2006

Last Update Submit

April 5, 2007

Conditions

Leukemia, Lymphocytic, Acute, L1

Keywords

OsteoporosisChildhood acute lymphoblastic leukemia

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaOsteoporosis

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jadranka Popovic, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 26, 2006

First Posted

May 29, 2006

Study Start

March 1, 2004

Study Completion

October 1, 2006

Last Updated

April 6, 2007

Record last verified: 2007-04

Locations

US(1)