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Creatine on Bone Mass in Postmenopausal Women

This study is currently recruiting participants.
Verified January 2015 by Bruno Gualano, University of Sao Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT01472393
First Posted: November 16, 2011
Last Update Posted: January 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
AlzChem AG
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 Bruno Gualano, University of Sao Paulo:

Primary Outcome Measures:
  • bone mineral density (BMD) [ Time Frame: 12 and 24 months ]

Secondary Outcome Measures:
  • bone markers [ Time Frame: 12 and 24 months ]
    will include CTX and P1NP

  • 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 ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472393


Contacts
Contact: Bruno Gualano, PhD 551130913096 gualano@usp.br

Locations
Brazil
University of Sao Paulo - School of Medicine Recruiting
Sao Paulo, Brazil, 01246-903
Contact: Melisa Madureira, PhD    5511 30617158    melisamadureira@usp.br   
Principal Investigator: Bruno Gualano, PhD         
Principal Investigator: Rosa M' Pereira, PhD         
Sponsors and Collaborators
University of Sao Paulo
AlzChem AG
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01472393     History of Changes
Other Study ID Numbers: USP.BONE
First Submitted: November 8, 2011
First Posted: November 16, 2011
Last Update Posted: January 30, 2015
Last Verified: January 2015

Keywords provided by Bruno Gualano, University of Sao Paulo:
creatine supplementation
bone mass
postmenopausal women
muscle function
bone markers