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Creatine Supplementation and Bone Mass

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ClinicalTrials.gov Identifier: NCT01163370
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : November 10, 2011
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief Summary:
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 or disease Intervention/treatment Phase
Osteopenia Osteoporosis Dietary Supplement: creatine supplementation Other: exercise training Other: placebo (dextrose) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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

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



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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

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

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01163370     History of Changes
Other Study ID Numbers: creatine and bone
First Posted: July 15, 2010    Key Record Dates
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