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Creatine Supplementation and Bone Mass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01163370
First received: July 14, 2010
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • bone mineral density [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cognition [ Time Frame: six months ] [ Designated as safety issue: No ]
  • physical capacity [ Time Frame: six months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   60 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01163370     History of Changes
Other Study ID Numbers: creatine and bone
Study First Received: July 14, 2010
Last Updated: November 9, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on May 21, 2013