Bone HealthPhase 3ExkidsNCT01087138
Study to Determine How Exercise and Calcium Affect Pubertal Bone
A Phase 3 study testing exercise and exercise and calcium in people with Bone Health, run by Creighton University at 1 site in United States.
Trial summary
To determine if increasing the amount of calcium that girls eat or the degree of exercise in which they participate will increase their bone strength. Read more about this study
- Who is it for?
- Ages 9 to 9 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Health
- What is being tested?
- exercise and exercise and calcium
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Apr 2007
- Phase
- Phase 3
- 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 9 to 9 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 9-10 years of age
- Premenarcheal
- Female
Who cannot join
- corticosteroid or anticonvulsant therapy
- lactose intolerance or milk allergy
- family history of hypercholesterolemia
- mental or physical handicaps
- chronic disease
- body mass index ³ 85th percentile for age and gender
- baseline calcium intake of > 1100 mg/day
- participation in team sports > 3 times per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Exercise and Calcium Foods on Pubertal Bone Gain
To determine if increasing the amount of calcium that girls eat or the degree of exercise in which they participate will increase their bone strength.
- Conditions
- Bone Health
- Being tested
- exercise, exercise and calcium
- Keywords
- bone health, bone density, bone mass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
exercise class 3x's/week
exercise and calciumBehavioural
exercise class 3x's/week and 1500mg calcium intake
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | exercise class 3x's/week Receives: Behavioral: exercise |
| exercise and calcium intake | Experimental | exercise class 3x's/week and 1500mg calcium/day Receives: Behavioral: exercise and calcium |
| usual exercise and calcium | No intervention | usual exercise and calcium intake |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2010 (estimated)
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone HealthStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087138
- Sponsor's protocol ID
- 97-11384
- Acronym
- Exkids
- Status last verified
- Mar 2010
- First submitted
- 12 Mar 2010
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise and Calcium Foods on Pubertal Bone Gain
- ClinicalTrials.gov ID
- NCT01087138
- Acronym / sponsor ID
- Exkids / 97-11384
- Conditions
- Bone Health
- Keywords
- bone health, bone density, bone mass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 16 Mar 2010 (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.
To determine if increasing the amount of calcium that girls eat or the degree of exercise in which they participate will increase their bone strength.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: exerciseexercise class 3x's/week |
| exercise and calcium intake | Experimental | Behavioral: exercise and calciumexercise class 3x's/week and 1500mg calcium/day |
| usual exercise and calcium | No intervention | –usual exercise and calcium intake |
Who may qualify
- Ages
- 9 to 9 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 9-10 years of age
- Premenarcheal
- Female
Key exclusion criteria (8 listed)
- corticosteroid or anticonvulsant therapy
- lactose intolerance or milk allergy
- family history of hypercholesterolemia
- mental or physical handicaps
- chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseexercise class 3x's/week | Behavioural | Exercise |
| exercise and calciumexercise class 3x's/week and 1500mg calcium intake | Behavioural | exercise and calcium intake |
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 16 Mar 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing exercise and exercise and calcium in people with Bone Health, run by Creighton 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 3 inclusion and 8 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 16 Mar 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 16 Mar 2010; AzTrials last refreshed its copy on 29 Oct 2026.