Glucocorticoid-induced Osteopenia in Children

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00289328
First received: February 8, 2006
Last updated: March 1, 2010
Last verified: March 2010
  Purpose

The purpose of this study is to characterize the skeletal deficits and risk factors for impaired skeletal development in children requiring glucocorticoid therapy.

We will compare the bone health of children treated with prednisone for nephrotic syndrome (NS with those treated with prednisone for Crohn's Disease (CD). Childhood NS usually responds to prednisone and is not characterized by pathologies that can impact on bone. In contrast, CD is treated with prednisone, but is independently associated with poor growth and maturation, nutritional deficiencies and inflammation. Due to the differences in the diseases, this comparison will allow us to distinguish between the prednisone-related and disease-related effects on bone in the two disease states.


Condition
Crohn's Disease
Nephrotic Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment: 550
Study Start Date: November 2001
Study Completion Date: April 2006
Detailed Description:

Prednisone, a glucocorticoid medication, is widely used for many pediatric disorders. Studies have shown that this drug decreases bone formation, decreasing bone density and bone thickness in children. Prednisone induced osteopenia, or low bone density, can be worsened by the effects of the underlying disease, such as delayed growth and maturation, malnutrition, and increased bone resorption (removal) by inflammatory compounds. The combined effects of decreased bone formation and increased resorption may be particularly detrimental to the growing skeleton.

Subjects will include 15 newly diagnosed NS patients, 60 patients with pre-existing NS, 90 patients with newly diagnosed CD, 45 patients diagnosed within the last two years and 200 healthy controls of similar age, gender and ethnicity. Participants will visit the Children's Hospital of Philadelphia (CHOP) three times over a 12-month period for assessment of bone mineralization and turnover, fracture history, dietary calcium intake, physical activity, growth, body composition, muscle strength and glucocorticoid exposure.

  Eligibility

Ages Eligible for Study:   5 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 5-21
  • clinical and pathological diagnosis of Crohn's Disease within the last 2 years
  • clinical diagnosis of nephrotic syndrome and taking corticosteroids within the last year
  • normal renal function GFR>75 ml/min/1.73m2
  • healthy controls

Exclusion Criteria:

  • other major medical conditions affecting growth and/or bone health
  • significant cognitive or developmental disorders (if child is unable to cooperate sufficiently)
  • nonambulatory
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289328

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19096
Sponsors and Collaborators
Investigators
Principal Investigator: Mary B Leonard, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00289328     History of Changes
Other Study ID Numbers: DK60030 (completed)
Study First Received: February 8, 2006
Last Updated: March 1, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Crohn Disease
Nephrotic Syndrome
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Nephrosis
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014