NCT02047864

Brief Summary

Osteoporosis is an important health problem, costing the Canadian health care system over $2 billion per year. Loss of bone mineral and bone fragility is especially prevalent in postmenopausal women. Of all osteoporotic fractures, hip fractures are the most traumatic. Creatine monohydrate is a nutritional supplement that is often combined with strength training to increase strength and muscle mass. The investigators recently completed a pilot study in a small number of postmenopausal women (n=33) that showed that creatine monohydrate significantly improved hip bone mineral density during a 1-year resistance training program. In our current proposal the investigators want to determine whether creatine combined with strength training can have an even larger effect on bone mineral density at the hip if given over 2 years in a large group of postmenopausal women (n=240). The investigators also want to determine whether this leads to reduced fractures in these women for up to a year after completing the creatine and strength training program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

5 years

First QC Date

January 26, 2014

Last Update Submit

June 10, 2020

Conditions

OsteoporosisSarcopenia

Keywords

OsteoporosisSarcopeniaStrengthBoneMuscleCreatine

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in femoral neck bone mineral density

    baseline, 12 months, 24 months

Secondary Outcomes (19)

  • Change from baseline in total hip bone mineral density

    baseline, 12 months, 24 month

  • Change from baseline in trochanter bone mineral density

    baseline, 12 months, 24 month

  • Change from baseline in Wards bone mineral density

    baseline, 12 months, 24 months

  • Change from baseline in lumbar spine bone mineral density

    baseline, 12 months, 24 months

  • Change from baseline in whole body bone mineral density

    baseline, 12 months, 24 months

  • +14 more secondary outcomes

Study Arms (2)

Creatine monohydrate

EXPERIMENTAL

Creatine monohydrate to be given during a resistance training program

Dietary Supplement: Creatine monohydrate

Sugar pill

PLACEBO COMPARATOR

Placebo to be given during a resistance training program

Dietary Supplement: Creatine monohydrate

Interventions

Creatine monohydrateDIETARY_SUPPLEMENT
Creatine monohydrateSugar pill

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women
  • Low or moderate risk of fracture

You may not qualify if:

  • High risk of fracture
  • Have taken any bone-altering drugs within the previous 12 months
  • Have taken creatine monohydrate in the previous 12 months
  • Currently taking systemic corticosteroids
  • Have Crohn's Disease or Cushings Disease
  • Have severe osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5B2, Canada

Location

Related Publications (1)

  • Chilibeck PD, Candow DG, Gordon JJ, Duff WRD, Mason R, Shaw K, Taylor-Gjevre R, Nair B, Zello GA. A 2-yr Randomized Controlled Trial on Creatine Supplementation during Exercise for Postmenopausal Bone Health. Med Sci Sports Exerc. 2023 Oct 1;55(10):1750-1760. doi: 10.1249/MSS.0000000000003202. Epub 2023 May 5.

    PMID: 37144634DERIVED

MeSH Terms

Conditions

OsteoporosisSarcopenia

Interventions

Creatine

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Philip D Chilibeck, PhD

    University of Saskatchewan

    PRINCIPAL INVESTIGATOR

  • Darren Candow, PhD

    University of Regina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2014

First Posted

January 28, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2019

Study Completion

July 1, 2019

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)