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Creatine Supplementation and Bone Mass

Primary Purpose

Osteopenia, Osteoporosis

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

creatine supplementation

exercise training

placebo (dextrose)

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring creatine supplementation, resistance training, osteopenia, osteoporosis, bone mineral density

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

School of Medicine - Division of Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

control and exercise

creatine

exercise and creatine

placebo

Arm Description

this is trained and receives placebo

this is non-exercise trained and receives creatine supplementation

this is exercised trained and receives creatine supplementation

this only receives placebo (dextrose)

Outcomes

Primary Outcome Measures

bone mineral density

Secondary Outcome Measures

cognition

physical capacity

including muscle strength, balance and muscle function

Full Information

NCT ID

NCT01163370

First Posted

July 14, 2010

Last Updated

November 9, 2011

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01163370

Brief Title

Creatine Supplementation and Bone Mass

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteopenia, Osteoporosis

Keywords

creatine supplementation, resistance training, osteopenia, osteoporosis, bone mineral density

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control and exercise

Arm Type

Placebo Comparator

Arm Description

this is trained and receives placebo

Arm Title

creatine

Arm Type

Experimental

Arm Description

this is non-exercise trained and receives creatine supplementation

Arm Title

exercise and creatine

Arm Type

Experimental

Arm Description

this is exercised trained and receives creatine supplementation

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

this only receives placebo (dextrose)

Intervention Type

Dietary Supplement

Intervention Name(s)

creatine supplementation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

exercise training

Intervention Description

resistance training twice a week for 24 weeks

Intervention Type

Other

Intervention Name(s)

placebo (dextrose)

Intervention Description

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

Primary Outcome Measure Information:

Title

bone mineral density

Time Frame

six months

Secondary Outcome Measure Information:

Title

cognition

Time Frame

six months

Title

physical capacity

Description

including muscle strength, balance and muscle function

Time Frame

six months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rosa MR Pereira, PhD

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bruno Gualano, PhD

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Medicine - Division of Rheumatology

City

Sao Paulo

ZIP/Postal Code

01246-903

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Creatine Supplementation and Bone Mass

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