Bone Development in Adolescent Girls: Effects of Calcium and Exercise
Primary Purpose
Osteoporosis
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calcium rich diet
Weight bearing exercise
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Weight-bearing exercise, Calcium-rich diet, Adolescents, Females, Bone mass, Osteopenia
Eligibility 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
Sites / Locations
- Creighton University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00063011
First Posted
June 19, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00063011
Brief Title
Bone Development in Adolescent Girls: Effects of Calcium and Exercise
Official Title
Calcium and Exercise Effect on Pubertal Bone Gain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2003
Overall Recruitment Status
Unknown status
Study Start Date
May 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Weight-bearing exercise, Calcium-rich diet, Adolescents, Females, Bone mass, Osteopenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Calcium rich diet
Intervention Type
Behavioral
Intervention Name(s)
Weight bearing exercise
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan M. Lappe, Ph.D.
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bone Development in Adolescent Girls: Effects of Calcium and Exercise
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