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Home > "B" Clinical Trials Conditions > Building Better Bones in Children  Building Better Bones in Children
Building Better Bones in Children
For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Center for Research Resources (NCRR)
Synopsis: Calcium is important for healthy bone growth in children. Poor bone growth and development during childhood can lead to osteoporosis later in life. This study will evaluate a nutrition education program designed to increase the amount of calcium children receive. The study will determine whether the program will result in long-term dietary changes and healthier bones in children.
Details: Increased calcium intake is effective in increasing bone mineral density in children, but the effect disappears when calcium supplements are discontinued. Increased dietary calcium from daily food sources may have a greater impact on bone density than that achieved by calcium supplements. However, studies have not yet demonstrated sustained achievement of increased calcium from food sources. In addition, the effects of baseline calcium intake, bone density, and puberty status may influence bone response to increased dietary calcium. This study will develop, implement, and evaluate a Behavioral Modification-Nutrition Education (BM-NE) Intervention Program designed to promote sustained increases in dietary calcium. The study will quantify the impact of increased dietary calcium on bone density during growth and development and will determine whether the presence of risk factors for low bone density influences compliance with the program. Participants will be recruited into two groups: a group of healthy children with no known risk factors for low bone density (i.e., no known chronic disease or previous oral steroid exposure), and a group of healthy children with potential risk factors for low bone density (previous fracture from usual childhood activities, daily dietary calcium refusal, lactose intolerance, family history of osteoporosis). Children with and without risk factors will be randomly assigned to participate in an intensive BM-NE intervention group or a usual care group that will receive counseling on bone health. The BM-NE Program will consist of five group sessions for parents and children over 6 weeks. The program will use individualized plans to increase children's calcium intake to 1500 mg per day. Children will be followed for 3 years. Primary outcome measures will include daily calcium intake and bone mineral density. Data on height, weight, sexual and skeletal maturation, and physical activity will also be collected.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 7 Years/10 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Height or weight above the third percentile for age - Normal weight (< 130% of desirable body weight) - English speaking Exclusion Criteria - Significant health condition - Medication known to affect growth (e.g., thyroxin, growth hormone, steroid medication) - Ritalin or Adderall medication - Significant developmental or delay impairment (e.g., autism, cerebral palsy, mental retardation)
Total Enrollment: 139
Location and Contact Information:
Overall Study Official:
BabetteZemel, Principal Investigator, Children's Hospital of Philadelphia
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399
United States
Additional Information:
Study ID Numbers: R01HD37748;
Study Start Date: June 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063037
Other Osteoporosis Studies:
1. Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer
2. Zometa - Femara Adjuvant Synergy Trial (ZFAST) - Cancer Treatment Related Bone Loss in Postmenopausal Women with Estrogen Receptor Positive and/or Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
3. Parathyroid Hormone (PTH) with Alendronate for Osteoporosis
4. PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
5. Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis
Related Studies:
Other Osteoporosis Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Building Better Bones in Children
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