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Bone Development in Adolescent Girls: Effects of Calcium and Exercise

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ClinicalTrials.gov Identifier: NCT00063011
Recruitment Status : Unknown
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Active, not recruiting
First Posted : June 20, 2003
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Behavioral: Calcium rich diet Behavioral: Weight bearing exercise Phase 1 Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Calcium and Exercise Effect on Pubertal Bone Gain
Study Start Date : May 1998

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U.S. FDA Resources





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Ages Eligible for Study:   9 Years to 10 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063011


Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Joan M. Lappe, Ph.D. Creighton University

Additional Information:
ClinicalTrials.gov Identifier: NCT00063011     History of Changes
Other Study ID Numbers: R01HD036601 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Weight-bearing exercise
Calcium-rich diet
Adolescents
Females
Bone mass
Osteopenia

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs