Crohn's DiseaseNCT00289328
Glucocorticoid-induced Osteopenia in Children
An observational study of Crohn's Disease and Nephrotic Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 5 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Nephrotic Syndrome
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Apr 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- other major medical conditions affecting growth and/or bone health
- significant cognitive or developmental disorders (if child is unable to cooperate sufficiently)
- nonambulatory
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19096
About this study
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.
Read the 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.
- Conditions
- Crohn's Disease, Nephrotic Syndrome
- Medical subject headings
- Crohn Disease, Nephrotic Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startNov 2001
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 550 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Mary B Leonard, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289328
- Sponsor's protocol ID
- DK60030 (completed)
- Status last verified
- Mar 2010
- First submitted
- 8 Feb 2006
- Last updated
- 2 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoid-induced Osteopenia in Children
- ClinicalTrials.gov ID
- NCT00289328
- Acronym / sponsor ID
- DK60030 (completed)
- Conditions
- Crohn's Disease, Nephrotic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 550 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Nov 2001
- Study completion
- Apr 2006 (actual)
- First posted
- 9 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- other major medical conditions affecting growth and/or bone health
- significant cognitive or developmental disorders (if child is unable to cooperate sufficiently)
- nonambulatory
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary B Leonard, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Nephrotic Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.