Osteoporosis Clinical Trial
Official title:
Calcium and Exercise Effect on Pubertal Bone Gain
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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