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| Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00063011 |
Purpose
Osteoporosis is a major public health problem. Prevention of osteoporosis depends in part on good bone development in childhood and adolescence. This study will evaluate a weight-bearing exercise program and high-calcium diet on bone development in adolescent girls.
| Condition | Intervention | Phase |
|
Osteoporosis |
Behavioral: Calcium rich diet Behavioral: Weight bearing exercise |
Phase I Phase II |
| MedlinePlus related topics: | Exercise and Physical Fitness Osteoporosis |
| Drug Information available for: | Calcium gluconate |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
| Official Title: | Calcium and Exercise Effect on Pubertal Bone Gain |
| Estimated Enrollment: | 107 |
| Study Start Date: | May 1998 |
There are currently few safe and effective methods for restoring lost bone to the osteoporotic skeleton. Therefore, prevention of osteoporosis is crucial. If skeletal development can be maximized during growth, young people will begin adulthood with optimal bone mass and will be less likely to develop osteoporosis in later years. This study will determine the effects of weight-bearing physical activity and a high-calcium diet on bone mass in adolescent girls.
Participants in this study will be randomized to one of three study arms. Girls in Arm 1 will consume their usual diets and will participate in a weight-bearing exercise program that meets 3 times per week. Girls in Arm 2 will also participate in a weight-bearing exercise program that meets 3 times per week and will be given high calcium foods to supply 1500 mg of calcium per day. Girls in Arm 3 will consume their usual diet and maintain their customary activity level. Study visits occur every 6 months; participants will be followed for 4 ½ years. Assessments will include a medical and social history and measurements of spine, hip, radius, and total body bone mineral content (BMC); calcaneal speed of sound (SOS); height; weight; and Tanner stage.
Eligibility
| Ages Eligible for Study: | 9 Years to 10 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
More Information
Click here for more information about Osteoporosis research at Creighton University. 
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| Study ID Numbers: | R01HD36601 |
| First Received: | June 19, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00063011 |
| Health Authority: | United States: Federal Government |
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