Creatine on Bone Mass in Postmenopausal Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by University of Sao Paulo
AlzChem AG
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo Identifier:
First received: November 8, 2011
Last updated: January 29, 2015
Last verified: January 2015
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.

Condition Intervention
Postmenopausal Women
Dietary Supplement: Creatine supplementation
Dietary Supplement: dextrose (placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • bone mineral density (BMD) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bone markers [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    will include CTX and P1NP

  • history of falls [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • bone microarchitecture [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • muscle function [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • lean mass [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • laboratory parameters [ Time Frame: 12 and 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Creatine supplementation Dietary Supplement: Creatine supplementation
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.
Placebo Comparator: Placebo Dietary Supplement: 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.


Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01472393

Contact: Bruno Gualano, PhD 551130913096

University of Sao Paulo - School of Medicine Recruiting
Sao Paulo, Brazil, 01246-903
Contact: Melisa Madureira, PhD    5511 30617158   
Principal Investigator: Bruno Gualano, PhD         
Principal Investigator: Rosa M' Pereira, PhD         
Sponsors and Collaborators
University of Sao Paulo
AlzChem AG
Principal Investigator: Bruno Gualano, PhD University of Sao Paulo
Principal Investigator: Rosa M Pereira, PhD University of Sao Paulo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bruno Gualano, Professor, University of Sao Paulo Identifier: NCT01472393     History of Changes
Other Study ID Numbers: USP.BONE 
Study First Received: November 8, 2011
Last Updated: January 29, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
creatine supplementation
bone mass
postmenopausal women
muscle function
bone markers processed this record on April 27, 2016