Bone Mineral DensityNCT00619047
The Role of Impact Activity in Peripubertal Bone Accrual
An observational study of Bone Mineral Density, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Mineral Density
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- Women only
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Subjects between the ages of 10-12 will be asked to participate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Human Performance
Syracuse, New York, 13210
About this study
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.
Read the detailed description
As above
- Conditions
- Bone Mineral Density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJan 2002
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Mineral DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Tamara A Scerpella, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619047
- Sponsor's protocol ID
- Bone Density Study
- Status last verified
- Nov 2009
- First submitted
- 6 Feb 2008
- Last updated
- 20 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Impact Activity in Peripubertal Bone Accrual
- ClinicalTrials.gov ID
- NCT00619047
- Acronym / sponsor ID
- Bone Density Study
- Conditions
- Bone Mineral Density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As above
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | – |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Subjects between the ages of 10-12 will be asked to participate
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2009.
Related trials for Bone Mineral Density
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Recruiting
Digital Eye®-Assisted Bone Density Classification and Primary Dental Implant Stability.
Bone Mineral Density, Primary Implant Stability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara A Scerpella, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Mineral Density, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2009.