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View Clinical Trial (Medical Research Study)
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Bone Health of Obese Adolescents During Weight Loss - NCT00609713-19104 (Clinical Trial 201810)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy201810.aspx
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| City: |
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Philadelphia |
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State:
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PA |
| Zip Code: |
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19104 |
| Conditions: |
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Pediatric Obesity |
| Purpose: |
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The long-term goal of this proposal is to understand the impact of obesity and obesity
treatment on bone health during adolescence and how to preserve it. The recent pediatric
obesity epidemic raises important clinical and public health questions about the effects of
childhood-onset obesity and its treatment on bone health. Osteoporotic fractures are a major
cause of morbidity and mortality in the aged, and peak bone mass (PBM), achieved shortly
after puberty, is a key determinant of bone strength and lifetime fracture risk. Given the
current obesity epidemic, obesity treatment during adolescence will continue to be
necessary. The benefits of pediatric obesity treatment are unquestionable. However, the
potential detrimental effects of weight loss on bone density and dimensions are not known in
adolescents and are the focus of this proposal.
This study will focus on the impact of pediatric-onset obesity and its treatment on bone
health, using two approaches: comparing obese and non-obese adolescents and comparing obese
adolescents before and after weight loss. We hypothesize that (a) compared to non-obese
controls, obese adolescents have stronger bones, and that (b) bone strength of obese
adolescents decreases during weight loss compared to usual care, which would suggest a need
to promote bone health during successful weight loss in obese adolescents.
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| Study summary: |
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Context: The childhood obesity epidemic raises important clinical and public health
questions about the effects of both obesity and obesity treatment on bone development.
Osteoporotic fractures are a major cause of morbidity and mortality in the aged. However,
peak bone mass, achieved shortly after puberty, is the key determinant of lifetime
osteoporotic fracture risks. The size and direction of effects of obesity and weight loss
on bone health in childhood are unclear, partly because of bone ascertainment issues. Obese
children and adolescents may have elevated fracture risks, contrary to expectations based on
adult data. Objectives: Primary aims of the proposed study are to: 1) characterize and
compare bone health of obese and non-obese adolescents using the most accurate methods
available, and 2) investigate the impact of comprehensive behavior weight control program on
the bone health of obese adolescents. Study Design: Aim 1 will use a case-control design
to compare bone status measures of 88 obese adolescents (ages 10 to 14 years), to be
recruited for a randomized obesity treatment trial, with the same measurements of 51
contemporary non-obese control adolescents. For Aim 2, the 88 obese adolescents will be
enrolled in a 12-month randomized trial, with 1:1 assignment, of a comprehensive behavioral
weight control program vs. individualized nutrition education (usual care). This randomized
trial is the object of this registration. Study Measures: For both aims the primary outcome
will be bone strength, estimated by stress-strength index, and measured by peripheral
quantitative computerized tomography (pQCT) at the tibia, a weight-bearing site. |
| Criteria: |
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Inclusion Criteria:
Eligible participants will be 10.0 to 14.9 years of age, with a body mass index (BMI)
above the 97th percentile for age (~ +1.88 SD) and below +3.00 SD or less than 300 lb (~
136 kg), whichever is lower.
Exclusion Criteria:
1. Syndromic or secondary obesity,
2. Developmental delay requiring special education,
3. Depression, psychosis,
4. Eating disorders that involve insufficient or excessive food intake, such as anorexia
nervosa or bulimia,
5. Orthopedic problems interfering with moderate to vigorous physical activity,
6. Diabetes,
7. Polycystic ovary syndrome,
8. History of systemic corticosteroids use for more than three months cumulatively, use
of immunomodulators, anticonvulsivants, weight loss medications (including diet
supplements) and any other medications, or chronic conditions that could interfere
with the intervention or with bone health.
9. Weight loss in the preceding six months of 5% or more, participation in another
weight loss program,
10. Cigarette smoking (smoking and smoking cessation can affect weight and bones),
11. Sexual activity without contraception and/or pregnancy,
12. Subjects without a primary care provider or with a provider unwilling to provide to
the research team medical information on the child will be excluded. |
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| Study is available at: |
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The Children's Hospital of Philadelphia
Philadelphia, PA 19104
United States
Primary Contact:
Snejana Nihtianova, MS, MS
Email: nihtianova@email.chop.edu
Phone: 215-590-4042
Secondary Contact:
Nicolas Stettler, MD, MSCE
Email: nstettle@upenn.edu
Phone: 215-590-1686 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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