Creatine on Bone Mass in Postmenopausal Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by University of Sao Paulo
Sponsor:
Collaborator:
AlzChem AG
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01472393
First received: November 8, 2011
Last updated: November 15, 2011
Last verified: November 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 2-year 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: 24 months ] [ Designated as safety issue: No ]

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

  • history of falls [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Creatine supplementation Dietary Supplement: Creatine supplementation
The CR group will receive 3g of Cr monohydrate (Creapure®) per day throughout the trial. The amount will be taken as three single doses of 1 g creatine MH during the day (morning, lunch, evening). 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

Ages Eligible for Study:   50 Years to 80 Years
Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided by University of Sao Paulo

Additional 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
Study First Received: November 8, 2011
Last Updated: November 15, 2011
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

ClinicalTrials.gov processed this record on August 21, 2014