NCT01163370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 10, 2011

Status Verified

November 1, 2011

Enrollment Period

1.1 years

First QC Date

July 14, 2010

Last Update Submit

November 9, 2011

Conditions

OsteopeniaOsteoporosis

Keywords

creatine supplementationresistance trainingosteopeniaosteoporosisbone mineral density

Outcome Measures

Primary Outcomes (1)

  • bone mineral density

    six months

Secondary Outcomes (2)

  • cognition

    six months

  • physical capacity

    six months

Study Arms (4)

control and exercise

PLACEBO COMPARATOR

this is trained and receives placebo

Other: exercise trainingOther: placebo (dextrose)

creatine

EXPERIMENTAL

this is non-exercise trained and receives creatine supplementation

Dietary Supplement: creatine supplementation

exercise and creatine

EXPERIMENTAL

this is exercised trained and receives creatine supplementation

Dietary Supplement: creatine supplementationOther: exercise training

placebo

PLACEBO COMPARATOR

this only receives placebo (dextrose)

Other: placebo (dextrose)

Interventions

creatine supplementationDIETARY_SUPPLEMENT

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

creatineexercise and creatine
exercise trainingOTHER

resistance training twice a week for 24 weeks

control and exerciseexercise and creatine
placebo (dextrose)OTHER

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

control and exerciseplacebo

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • osteopenia and osteoporosis
  • women older than 60 years old

You may not qualify if:

  • cardiovascular diseases or muscular disturbances precluding exercise training
  • drugs affecting bone metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine - Division of Rheumatology

São Paulo, São Paulo, 01246-903, Brazil

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosis

Interventions

CreatineExerciseGlucose

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Rosa MR Pereira, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Bruno Gualano, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

July 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 10, 2011

Record last verified: 2011-11

Locations

BR(1)