Creatine on Bone Mass in Postmenopausal Women

University of Sao Paulo

Status: Unknown

Conditions: Postmenopausal Women

Treatments: Dietary Supplement: dextrose (placebo); Dietary Supplement: Creatine supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01472393

USP.BONE

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Creatine supplementation

Experimental group

Treatment:

Dietary Supplement: Creatine supplementation

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: dextrose (placebo)