Creatine Supplementation and Bone Mass

November 9, 2011 updated by: Bruno Gualano, University of Sao Paulo
Resistance training as well as creatine supplementation may increase bone mass. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on bone mass in elderly women with osteopenia and osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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
        • School of Medicine - Division of Rheumatology

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • osteopenia and osteoporosis
  • women older than 60 years old

Exclusion Criteria:

  • cardiovascular diseases or muscular disturbances precluding exercise training
  • drugs affecting bone metabolism

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control and exercise
this is trained and receives placebo
Other: exercise training
resistance training twice a week for 24 weeks
Other: placebo (dextrose)
20g/d for 7 days followed by 5g/d for 23 weeks
Experimental: creatine
this is non-exercise trained and receives creatine supplementation
Dietary supplement: creatine supplementation
20g/d for 7 days followed by 5g/d for 23 weeks
Experimental: exercise and creatine
this is exercised trained and receives creatine supplementation
Dietary supplement: creatine supplementation
20g/d for 7 days followed by 5g/d for 23 weeks
Other: exercise training
resistance training twice a week for 24 weeks
Placebo Comparator: placebo
this only receives placebo (dextrose)
Other: placebo (dextrose)
20g/d for 7 days followed by 5g/d for 23 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bone mineral density
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognition
Time Frame: six months
six months
physical capacity
Time Frame: six months
including muscle strength, balance and muscle function
six months

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Investigators

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

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

July 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Estimate)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • creatine and 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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