NCT00619047

Brief Summary

Osteoporosis has been established as a major public health problem, primarily effecting women. The attainment of maximal peak bone mass is crucial in the prevention of osteoporosis, yet little is known about the specifics of bone accrual. Physical activity has been identified as an important modifiable factor controlling bone accrual. It is has been shown that increased activity during peri-pubertal years increase bone mineral content during adulthood. Thus, strategies designed to increase peak bone mass should target the peri-pubertal years of critical bone acquisition. Hypothesis 1a: The amount of bone mineral accrued during the peri-pubertal years is greater in girls who engage in impact activity than in those who do not. Hypothesis 1b: The positive effects of impact activity on bone accrual are maintained after cessation of the activity, resulting in greater bone mineral density in girls who participate in impact activity during a portion of the peri-pubertal years than in those who never participated in impact activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2002

Longer than P75 for all trials

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

January 1, 2002

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

6.6 years

First QC Date

February 6, 2008

Last Update Submit

November 18, 2009

Conditions

Study Arms (1)

Observation

Eligibility Criteria

Age10 Years - 12 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Subjects were recruited into the following three groups based on their exposure to gymnastic activity. A) control, no gymnastic activity. B)retired gymnasts, who participated at study onset, but stopped gymnastics activity during the course of the study. C) active gymnast, who continues participation in gymnastics throughout the duration of the study.

You may qualify if:

  • Subjects between the ages of 10-12 will be asked to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Human Performance

Syracuse, New York, 13210, United States

Location

Study Officials

  • Tamara A Scerpella, MD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 20, 2008

Study Start

January 1, 2002

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations