NCT00000413

Brief Summary

This study will test an osteoporosis prevention program aimed at preadolescent girls between the ages of 10 and 12 who have not yet started their menstrual periods. Girls in this age group are adding large amounts of new bone to their skeletons. Adding more bone at this time of life can reduce a person's chances of developing osteoporosis (thinning bones) in later years. We will look at how this osteoporosis prevention program affects the amount of calcium in the girls' diets, the amount of weight-bearing exercise they do, and their bone mass measured using ultrasound testing of the heel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 1998

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
Last Updated

December 29, 2006

Status Verified

February 1, 2003

First QC Date

November 3, 1999

Last Update Submit

December 28, 2006

Conditions

Osteoporosis

Keywords

Osteoporosis preventionBehavioral/educational interventionPreadolescentCalciumExercisePeak bone massBone density

Interventions

Psychoeducational programBEHAVIORAL

Eligibility Criteria

Age9 Years - 13 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • and 10-year-old premenarchal girls (girls who have not started their periods).

You may not qualify if:

  • Comorbid conditions or medications that are associated with decreased bone density such as the following: corticosteroids; anticonvulsants; thiazide diuretics; history of cancer; Type I diabetes; thyrotoxicosis; hyperparathyroidism; Cushing's syndrome; juvenile rheumatoid arthritis; connective tissue disease or hemolytic anemia; asthma which may limit ability to participate in the exercise intervention; known history of dietary disorder, including anorexia, bulimia or lactose intolerance; postmenarchal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Ievers-Landis CE, Burant C, Drotar D, Morgan L, Trapl ES, Kwoh CK. Social support, knowledge, and self-efficacy as correlates of osteoporosis preventive behaviors among preadolescent females. J Pediatr Psychol. 2003 Jul-Aug;28(5):335-45. doi: 10.1093/jpepsy/jsg023.

    PMID: 12808010BACKGROUND

MeSH Terms

Conditions

OsteoporosisBehaviorMotor Activity

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • C. Kent Kwoh, MD

    Case Western Reserve Univ. and Univ. Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

July 1, 1998

Study Completion

June 1, 2002

Last Updated

December 29, 2006

Record last verified: 2003-02

Locations

US(1)