Glucocorticoid-induced Osteopenia in Children
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Listed as NCT00289328, this observational or N/A phase trial focuses on Crohn's Disease and Nephrotic Syndrome and remains completed. Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), it has been updated 7 times since 2001, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed
-
Sep 2024 — Present [monthly]
Completed
-
Jul 2024 — Sep 2024 [monthly]
Completed
-
Jan 2021 — Jul 2024 [monthly]
Completed
-
Jun 2018 — Jan 2021 [monthly]
Completed
▶ Show 2 earlier versions
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Apr 2018 — Jun 2018 [monthly]
Completed
Phase: NA → None
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Jan 2017 — Apr 2018 [monthly]
Completed NA
First recorded
Nov 2001
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
For direct contact, visit the study record on ClinicalTrials.gov .