Glucocorticoid-induced Osteopenia in Children

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00289328
Study type	Observational
Source	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status	Completed
Phase	N/A
Start date	November 2001
Completion date	April 2006

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03815851` - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery	N/A
Not yet recruiting	`NCT06100289` - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease	Phase 3
Completed	`NCT02883452` - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis	Phase 1
Recruiting	`NCT04777656` - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.	Phase 3
Terminated	`NCT03017014` - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting	`NCT05428345` - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Recruiting	`NCT06053424` - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease	Phase 1
Completed	`NCT02508012` - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases	N/A
Not yet recruiting	`NCT02858557` - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases	N/A
Terminated	`NCT02882841` - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients	N/A
Terminated	`NCT02417974` - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)	Phase 2
Completed	`NCT03010787` - A First Time in Human Study in Healthy Volunteers and Patients	Phase 1
Completed	`NCT02542917` - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Active, not recruiting	`NCT02316678` - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics	N/A
Completed	`NCT02154425` - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers	Phase 1
Completed	`NCT02193048` - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed	`NCT02265588` - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).	N/A
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Recruiting	`NCT02395354` - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease	N/A
Completed	`NCT01958827` - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease	Phase 3