Creatine on Bone Mass in Postmenopausal Women

January 29, 2015 updated by: Bruno Gualano, University of Sao Paulo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01246-903
        • Recruiting
        • University of Sao Paulo - School of Medicine
        • Contact:
        • Principal Investigator:
          • Rosa M' Pereira, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone mineral density (BMD)
Time Frame: 12 and 24 months
12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone markers
Time Frame: 12 and 24 months
will include CTX and P1NP
12 and 24 months
history of falls
Time Frame: 24 months
24 months
bone microarchitecture
Time Frame: 12 and 24 months
12 and 24 months
muscle function
Time Frame: 12 and 24 months
12 and 24 months
lean mass
Time Frame: 12 and 24 months
12 and 24 months
laboratory parameters
Time Frame: 12 and 24 months
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

AlzChem AG

Investigators

  • Principal Investigator: Bruno Gualano, PhD, University of Sao Paulo
  • Principal Investigator: Rosa M Pereira, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (Estimate)

November 16, 2011

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • USP.BONE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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