OsteopeniaNCT01163370
Creatine Supplementation and Bone Mass
A study testing creatine supplementation and exercise training in people with Osteopenia and Osteoporosis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Resistance training as well as creatine supplementation may increase bone mass. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- creatine supplementation and exercise training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Aug 2011
- Phase
- Interventional
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteopenia and osteoporosis
- women older than 60 years old
Who cannot join
- cardiovascular diseases or muscular disturbances precluding exercise training
- drugs affecting bone metabolism
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Medicine - Division of Rheumatology
São Paulo, São Paulo, 01246-903
About this study
Resistance training as well as creatine supplementation may increase bone mass. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis.
- Conditions
- Osteopenia, Osteoporosis
- Being tested
- creatine supplementation, exercise training, placebo (dextrose)
- Keywords
- creatine supplementation, resistance training, osteopenia, osteoporosis, bone mineral density
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatine supplementationDietary supplement
20g/d for 7 days followed by 5g/d for 23 weeks
exercise trainingOther
resistance training twice a week for 24 weeks
placebo (dextrose)Other
20g/d for 7 days followed by 5g/d for 23 weeks
| Study group | Role | What they receive |
|---|---|---|
| control and exercise | Placebo comparator | this is trained and receives placebo Receives: Other: exercise training; Other: placebo (dextrose) |
| creatine | Experimental | this is non-exercise trained and receives creatine supplementation Receives: Dietary Supplement: creatine supplementation |
| exercise and creatine | Experimental | this is exercised trained and receives creatine supplementation Receives: Dietary Supplement: creatine supplementation; Other: exercise training |
| placebo | Placebo comparator | this only receives placebo (dextrose) Receives: Other: placebo (dextrose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
Measured: six months
Secondary outcomes (2)
cognition
Measured: six months
physical capacity
including muscle strength, balance and muscle function
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Rosa MR Pereira, PhD, Principal investigator, University of Sao PauloBruno Gualano, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163370
- Sponsor's protocol ID
- creatine and bone
- Status last verified
- Nov 2011
- First submitted
- 14 Jul 2010
- Last updated
- 10 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Supplementation and Bone Mass
- ClinicalTrials.gov ID
- NCT01163370
- Acronym / sponsor ID
- creatine and bone
- Conditions
- Osteopenia, Osteoporosis
- Keywords
- creatine supplementation, resistance training, osteopenia, osteoporosis, bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Jul 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.
Resistance training as well as creatine supplementation may increase bone mass. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control and exercise | Placebo comparator | Other: exercise training, Other: placebo (dextrose)this is trained and receives placebo |
| creatine | Experimental | Dietary Supplement: creatine supplementationthis is non-exercise trained and receives creatine supplementation |
| exercise and creatine | Experimental | Dietary Supplement: creatine supplementation, Other: exercise trainingthis is exercised trained and receives creatine supplementation |
| placebo | Placebo comparator | Other: placebo (dextrose)this only receives placebo (dextrose) |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- osteopenia and osteoporosis
- women older than 60 years old
Key exclusion criteria (2 listed)
- cardiovascular diseases or muscular disturbances precluding exercise training
- drugs affecting bone metabolism
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 |
|---|---|---|
| creatine supplementation20g/d for 7 days followed by 5g/d for 23 weeks | Dietary supplement | creatine, exercise and creatine |
| exercise trainingresistance training twice a week for 24 weeks | Other | control and exercise, exercise and creatine |
| placebo (dextrose)20g/d for 7 days followed by 5g/d for 23 weeks | Other | control and exercise, placebo |
Primary outcome
bone mineral density
Time frame: six months
2 secondary outcomes
cognition
Time frame: six months
physical capacity
Time frame: six months
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 10 Nov 2011.
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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.
Rosa MR Pereira, PhD principal investigator
University of Sao Paulo
Bruno Gualano, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creatine supplementation and exercise training in people with Osteopenia and Osteoporosis, run by University of Sao Paulo at 1 site in Brazil.
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 2 inclusion and 2 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 10 Nov 2011. 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 Brazil. 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
bone mineral density (time frame: six months). It is what the study was designed to measure, not a finding.
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 10 Nov 2011.