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CompletedNCT01163370Updated Nov 10, 2011

Creatine Supplementation and Bone Mass

An interventional study of creatine supplementation and exercise training in Osteopenia and Osteoporosis, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2011-11-10.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Osteopenia
  • Osteoporosis

Keywords

  • creatine supplementation
  • resistance training
  • osteopenia
  • osteoporosis
  • bone mineral density
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 60 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • osteopenia and osteoporosis
  • women older than 60 years old

Exclusion criteria

Exclusion Criteria:

  • cardiovascular diseases or muscular disturbances precluding exercise training
  • drugs affecting bone metabolism
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Placebo comparator
    control and exercise

    this is trained and receives placebo

    Other: exercise training · Other: placebo (dextrose)

  • Experimental
    creatine

    this is non-exercise trained and receives creatine supplementation

    Dietary Supplement: creatine supplementation

  • Experimental
    exercise and creatine

    this is exercised trained and receives creatine supplementation

    Dietary Supplement: creatine supplementation · Other: exercise training

  • Placebo comparator
    placebo

    this only receives placebo (dextrose)

    Other: placebo (dextrose)

Interventions

  • Dietary supplementcreatine supplementation

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

  • Otherexercise training

    resistance training twice a week for 24 weeks

  • Otherplacebo (dextrose)

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

06

What researchers measure

Primary outcomes

  1. bone mineral density

    Time frame: six months

Secondary outcomes

  1. cognition

    Time frame: six months

  2. physical capacity

    including muscle strength, balance and muscle function

    Time frame: six months

07

Study locations

1 site
  • School of Medicine - Division of Rheumatology
    Sao Paulo, 01246-903, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01163370
Lead sponsor
University of Sao Paulo
Responsible party
Bruno Gualano (Professor, University of Sao Paulo) — Principal investigator
First posted
Jul 15, 2010
Start date
Jul 2010
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Nov 10, 2011

Study contacts

Rosa MR Pereira, PhD
principal investigator · University of Sao Paulo
Bruno Gualano, PhD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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