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Bone Development in Adolescent Girls: Effects of Calcium and Exercise - Article


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Clinical Trial: Bone Development in Adolescent Girls: Effects of Calcium and Exercise

This study is no longer recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

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 Treatment or Intervention Phase
Osteoporosis
 Behavior: Calcium rich diet
 Behavior: Weight bearing exercise
Phase I
Phase II

MedlinePlus related topics:  Osteoporosis

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

Further Study Details: 

Expected Total Enrollment:  107

Study start: 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   -   10 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria

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

Location Information


Nebraska
      Creighton University, Omaha,  Nebraska,  68131,  United States

Study chairs or principal investigators

Joan M. Lappe, Ph.D.,  Principal Investigator,  Creighton University   

More Information

Click here for more information about Osteoporosis research at Creighton University.

Study ID Numbers:  R01HD36601
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  June 19, 2003
ClinicalTrials.gov Identifier:  NCT00063011
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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Page Updated: October 3, 2005
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