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Creatine Supplementation and Bone Mass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163370
First Posted: July 15, 2010
Last Update Posted: November 10, 2011
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
  Purpose
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.

Condition Intervention
Osteopenia Osteoporosis Dietary Supplement: creatine supplementation Other: exercise training Other: placebo (dextrose)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bruno Gualano, University of Sao Paulo:

Primary Outcome Measures:
  • bone mineral density [ Time Frame: six months ]

Secondary Outcome Measures:
  • cognition [ Time Frame: six months ]
  • physical capacity [ Time Frame: six months ]
    including muscle strength, balance and muscle function


Enrollment: 60
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01163370


Locations
Brazil
School of Medicine - Division of Rheumatology
Sao Paulo, Brazil, 01246-903
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rosa MR Pereira, PhD University of Sao Paulo
Principal Investigator: Bruno Gualano, PhD University of Sao Paulo
  More Information

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01163370     History of Changes
Other Study ID Numbers: creatine and bone
First Submitted: July 14, 2010
First Posted: July 15, 2010
Last Update Posted: November 10, 2011
Last Verified: November 2011

Keywords provided by Bruno Gualano, University of Sao Paulo:
creatine supplementation
resistance training
osteopenia
osteoporosis
bone mineral density

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases