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Home > "B" Clinical Trials Conditions > Bone Development in Adolescent Girls: Effects of Calcium and Exercise  Bone Development in Adolescent Girls: Effects of Calcium and Exercise
Bone Development in Adolescent Girls: Effects of Calcium and Exercise
For Condition: Osteoporosis
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 9 Years/10 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - Tanner Stage of Development: Stage 1 Exclusion Criteria - History of lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any other significant health problem - Body mass index (BMI) >= 85th percentile for age and gender - Regularly have more than two practice sessions per week of dance, gymnastics, or organized team sports
Total Enrollment: 107
Location and Contact Information:
Overall Study Official:
JoanLappe, Principal Investigator, Creighton University
Creighton University
Omaha, Nebraska, 68131
United States
Additional Information:
Study ID Numbers: R01HD36601;
Study Start Date: May 1998
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063011
Other Osteoporosis Studies:
1. Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
2. Bone Development in Adolescent Girls: Effects of Calcium and Exercise
3. Hormone Replacement in Young Women with Premature Ovarian Failure
4. Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients with Prostate Cancer
5. Once Weekly Parathyroid Hormone for Osteoporosis
Related Studies:
Other Osteoporosis Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Bone Development in Adolescent Girls: Effects of Calcium and Exercise
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