Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063011
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-06-19
Brief Title:
Bone Development in Adolescent Girls Effects of Calcium and Exercise
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Calcium and Exercise Effect on Pubertal Bone Gain
Status:
UNKNOWN
Status Verified Date:
2003-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None