NCT00063011

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2003

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2003

First QC Date

June 19, 2003

Last Update Submit

June 23, 2005

Conditions

Osteoporosis

Keywords

Weight-bearing exerciseCalcium-rich dietAdolescentsFemalesBone massOsteopenia

Interventions

Calcium rich dietBEHAVIORAL
Weight bearing exerciseBEHAVIORAL

Eligibility Criteria

Age9 Years - 10 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Tanner Stage of Development: Stage 1

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

OsteoporosisBone Diseases, Metabolic

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Joan M. Lappe, Ph.D.

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2003

First Posted

June 20, 2003

Study Start

May 1, 1998

Last Updated

June 24, 2005

Record last verified: 2003-05

Locations

US(1)