Postmenopausal WomenNCT01472393
Creatine on Bone Mass in Postmenopausal Women
A study testing Creatine supplementation in people with Postmenopausal Women, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- Creatine supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Dec 2017
- 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 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy postmenopausal women
- T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD
Who cannot join
- drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation)
- low BMI (< 18.5 Kg/m2).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo - School of Medicine
São Paulo, São Paulo, 01246-903
Melisa Madureira, PhD, 5511 30617158, melisamadureira@usp.br
Bruno Gualano, PhD
About this study
Official title: A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women
Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.
- Conditions
- Postmenopausal Women
- Being tested
- Creatine supplementation, dextrose (placebo)
- Keywords
- creatine supplementation, bone mass, postmenopausal women, muscle function, bone markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine supplementationDietary supplement
The CR group will receive either 1g or 3g of Cr monohydrate (Creapure®) per day throughout the trial. The dose of creatine will be formulated in a tablet.
dextrose (placebo)Dietary supplement
The placebo group will be given the same dose of dextrose formulated in a tablet to be consumed under the same conditions. The two types of tablets will not be distinguishable from each other having the same appearance, taste and smell.
| Study group | Role | What they receive |
|---|---|---|
| Creatine supplementation | Experimental | Not described Receives: Dietary Supplement: Creatine supplementation |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: dextrose (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density (BMD)
Measured: 12 and 24 months
Secondary outcomes (6)
bone markers
will include CTX and P1NP
Measured: 12 and 24 months
history of falls
Measured: 24 months
bone microarchitecture
Measured: 12 and 24 months
muscle function
Measured: 12 and 24 months
lean mass
Measured: 12 and 24 months
laboratory parameters
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- AlzChem AG
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Bruno Gualano, PhD, Principal investigator, University of Sao PauloRosa M Pereira, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472393
- Sponsor's protocol ID
- USP.BONE
- Status last verified
- Jan 2015
- First submitted
- 8 Nov 2011
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sales LP, Pinto AJ, Rodrigues SF, Alvarenga JC, Goncalves N, Sampaio-Barros MM, Benatti FB, Gualano B, Rodrigues Pereira RM. Creatine Supplementation (3 g/d) and Bone Health in Older Women: A 2-Year, Randomized, Placebo-Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):931-938. doi: 10.1093/gerona/glz162.
PubMed 31257405Lobo DM, Tritto AC, da Silva LR, de Oliveira PB, Benatti FB, Roschel H, Niess B, Gualano B, Pereira RM. Effects of long-term low-dose dietary creatine supplementation in older women. Exp Gerontol. 2015 Oct;70:97-104. doi: 10.1016/j.exger.2015.07.012. Epub 2015 Jul 17.
PubMed 26192975Gualano B, Macedo AR, Alves CR, Roschel H, Benatti FB, Takayama L, de Sa Pinto AL, Lima FR, Pereira RM. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial. Exp Gerontol. 2014 May;53:7-15. doi: 10.1016/j.exger.2014.02.003. Epub 2014 Feb 13.
PubMed 24530883
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01472393
- Acronym / sponsor ID
- USP.BONE
- Conditions
- Postmenopausal Women
- Keywords
- creatine supplementation, bone mass, postmenopausal women, muscle function, bone markers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- AlzChem AG
- Study start
- Nov 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Nov 2011 (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.
Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creatine supplementation | Experimental | Dietary Supplement: Creatine supplementation |
| Placebo | Placebo comparator | Dietary Supplement: dextrose (placebo) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy postmenopausal women
- T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD
Key exclusion criteria (2 listed)
- drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation)
- low BMI (< 18.5 Kg/m2).
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 supplementationThe CR group will receive either 1g or 3g of Cr monohydrate (Creapure®) per day throughout the trial. The dose of creatine will be formulated in a tablet. | Dietary supplement | Creatine supplementation |
| dextrose (placebo)The placebo group will be given the same dose of dextrose formulated in a tablet to be consumed under the same conditions. The two types of tablets will not be distinguishable from each other having the same appearance, taste and smell. | Dietary supplement | Placebo |
Primary outcome
bone mineral density (BMD)
Time frame: 12 and 24 months
6 secondary outcomes
bone markers
Time frame: 12 and 24 months
history of falls
Time frame: 24 months
bone microarchitecture
Time frame: 12 and 24 months
muscle function
Time frame: 12 and 24 months
lean mass
Time frame: 12 and 24 months
laboratory parameters
Time frame: 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Derived from this study: PubMed 31257405Sales LP, Pinto AJ, Rodrigues SF, Alvarenga JC, Goncalves N, Sampaio-Barros MM, Benatti FB, Gualano B, Rodrigues Pereira RM. Creatine Supplementation (3 g/d) and Bone Health in Older Women: A 2-Year, Randomized, Placebo-Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Apr 17;75(5):931-938. doi: 10.1093/gerona/glz162.
- Derived from this study: PubMed 26192975Lobo DM, Tritto AC, da Silva LR, de Oliveira PB, Benatti FB, Roschel H, Niess B, Gualano B, Pereira RM. Effects of long-term low-dose dietary creatine supplementation in older women. Exp Gerontol. 2015 Oct;70:97-104. doi: 10.1016/j.exger.2015.07.012. Epub 2015 Jul 17.
- Derived from this study: PubMed 24530883Gualano B, Macedo AR, Alves CR, Roschel H, Benatti FB, Takayama L, de Sa Pinto AL, Lima FR, Pereira RM. Creatine supplementation and resistance training in vulnerable older women: a randomized double-blind placebo-controlled clinical trial. Exp Gerontol. 2014 May;53:7-15. doi: 10.1016/j.exger.2014.02.003. Epub 2014 Feb 13.
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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.
Bruno Gualano, PhD principal investigator
University of Sao Paulo
Rosa M Pereira, 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 in people with Postmenopausal Women, 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: status not confirmed, as of the sponsor's last update on 30 Jan 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno Gualano, PhD (551130913096, gualano@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (BMD) (time frame: 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01472393, which also lists 3 linked publications.
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 30 Jan 2015.