Overview

This trial is active, not recruiting.

Condition osteoporosis
Treatments calcium rich diet, weight bearing exercise
Phase phase 1/phase 2
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date May 1998
Trial size 107 participants
Trial identifier NCT00063011, R01HD36601

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose prevention

Eligibility Criteria

Female participants from 9 years up to 10 years old.

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

Additional Information

Official title Calcium and Exercise Effect on Pubertal Bone Gain
Principal investigator Joan M. Lappe, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).