Bone Development in Adolescent Girls: Effects of Calcium and Exercise

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00063011
First received: June 19, 2003
Last updated: June 23, 2005
Last verified: May 2003
  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 Intervention Phase
Osteoporosis
Behavioral: Calcium rich diet
Behavioral: Weight bearing exercise
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Calcium and Exercise Effect on Pubertal Bone Gain

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 107
Study Start Date: May 1998
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.

  Eligibility

Ages Eligible for Study:   9 Years to 10 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063011

Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Investigators
Principal Investigator: Joan M. Lappe, Ph.D. Creighton University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00063011     History of Changes
Other Study ID Numbers: R01HD36601
Study First Received: June 19, 2003
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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
Bone Diseases, Metabolic
Musculoskeletal Diseases
Calcium, Dietary
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014