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Bone Development in Adolescent Girls: Effects of Calcium and Exercise
This study is ongoing, but not recruiting participants.
Study NCT00063011   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: June 19, 2003   Last Updated: June 23, 2005   History of Changes

June 19, 2003
June 23, 2005
May 1998
 
 
 
Complete list of historical versions of study NCT00063011 on ClinicalTrials.gov Archive Site
 
 
 
Bone Development in Adolescent Girls: Effects of Calcium and Exercise
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.

Phase I, Phase II
Interventional
Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Osteoporosis
  • Behavioral: Calcium rich diet
  • Behavioral: Weight bearing exercise
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
107
 
 

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
Female
9 Years to 10 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00063011
 
R01HD36601
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Joan M. Lappe, Ph.D. Creighton University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP