Bone Development in Adolescent Girls: Effects of Calcium and Exercise

Osteoporosis Clinical Trial

Official title:

Calcium and Exercise Effect on Pubertal Bone Gain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00063011
• Other study ID #: R01HD036601
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: June 19, 2003
• Last updated: June 23, 2005
• Start date: May 1998

Study information

• Verified date: May 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 107
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Behavioral:
• Calcium rich diet

• Weight bearing exercise

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

External Links

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