Creatine on Bone Mass in Postmenopausal Women

NCT01472393 — Not applicable, Unknown, 200 participants, University of Sao Paulo

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A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women

Registry	NCT01472393
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	200 (Estimated)
Sponsor	University of Sao Paulo (Other); collaborators: AlzChem AG
Conditions	Postmenopausal Women
Interventions	Creatine supplementation, dextrose (placebo) (Dietary supplement)
Dates	start 2011-11-01, primary completion 2017-12-01 (estimated), completion 2017-12-01 (estimated), first posted 2011-11-16, last updated 2015-01-30
Locations	1 site in Brazil

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Creatine supplementation	Experimental	Dietary Supplement: Creatine supplementation
Placebo	Placebo comparator	Dietary Supplement: dextrose (placebo)

Creatine supplementation (Dietary 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.

+Outcome measures

Primary outcomes

bone mineral density (BMD) [12 and 24 months]

Secondary outcomes

bone markers [12 and 24 months]: will include CTX and P1NP
history of falls [24 months]
bone microarchitecture [12 and 24 months]
muscle function [12 and 24 months]
lean mass [12 and 24 months]
laboratory parameters [12 and 24 months]

+Eligibility

Sex: Female, ages: 50 Years to 80 Years, accepts healthy volunteers

Inclusion Criteria:

* healthy postmenopausal women
* T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD

Exclusion Criteria:

* 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).

+Locations (1)

Facility	City	Country	Status
University of Sao Paulo - School of Medicine	São Paulo, São Paulo	Brazil	Recruiting

+Publications

Results publication: 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. PMID 31257405
Results publication: Lobo 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. PMID 26192975
Results publication: Gualano 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. PMID 24530883

+Investigators

Bruno Gualano, PhD, Principal investigator, University of Sao Paulo
Rosa M Pereira, PhD, Principal investigator, University of Sao Paulo