Creatine Supplementation and Bone Mass

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163370
• Other study ID #: creatine and bone
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: November 9, 2011
• Start date: July 2010
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

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 (dextrose)
20g/d for 7 days followed by 5g/d for 23 weeks

Locations

Country	Name	City	State
Brazil	School of Medicine - Division of Rheumatology	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density		six months	No
Secondary	cognition		six months	No
Secondary	physical capacity	including muscle strength, balance and muscle function	six months	No