Creatine on Bone Mass in Postmenopausal Women

Postmenopausal Women Clinical Trial

Official title:

A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01472393
• Other study ID #: USP.BONE
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2011
• Last updated: January 29, 2015
• Start date: November 2011
• Est. completion date: December 2017

Study information

• Verified date: January 2015
• Source: University of Sao Paulo
• Contact: Bruno Gualano, PhD
• Phone: 551130913096
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Animal, in vitro and small-scale studies have suggested that creatine supplementation may augment bone mass. This clinical trial aims to investigate the effects of a 2-year creatine supplementation protocol on bone mass in postmenopausal women.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• healthy postmenopausal women

• T-score at lumbar spine, or femoral neck or total femur of between -1SD and -2.5SD

Exclusion Criteria:

• drugs or dietary supplements that may affect bone metabolism (e.g., bisphosphonates, AINEs, hormone replacement therapy, calcium, vitamin D, creatine supplementation)

• low BMI (< 18.5 Kg/m2).

Study Design

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

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

Dietary Supplement:
• Creatine supplementation
The CR group will receive either 1g or 3g of Cr monohydrate (Creapure®) per day throughout the trial. The dose of creatine will be formulated in a tablet.
• dextrose (placebo)
The placebo group will be given the same dose of dextrose formulated in a tablet to be consumed under the same conditions. The two types of tablets will not be distinguishable from each other having the same appearance, taste and smell.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo - School of Medicine	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	AlzChem AG

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density (BMD)		12 and 24 months	No
Secondary	bone markers	will include CTX and P1NP	12 and 24 months	No
Secondary	history of falls		24 months	No
Secondary	bone microarchitecture		12 and 24 months	No
Secondary	muscle function		12 and 24 months	No
Secondary	lean mass		12 and 24 months	No
Secondary	laboratory parameters		12 and 24 months	Yes