Creatine on Bone Mass in Postmenopausal Women

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01472393
• Collaborator: AlzChem AG (Industry)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 73
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Women	Dietary Supplement: Creatine supplementation; Dietary Supplement: dextrose (placebo)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial: Effects of Creatine Supplementation on Bone Mass and Turnover and Muscle Function in Healthy Postmenopausal Women
• Study Start Date: Nov 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2017
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Creatine supplementation	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.
Placebo Comparator: Placebo	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

1. bone mineral density (BMD) [12 and 24 months]

Secondary Outcome Measures

1. bone markers [12 and 24 months]

   will include CTX and P1NP

2. history of falls [24 months]

3. bone microarchitecture [12 and 24 months]

4. muscle function [12 and 24 months]

5. lean mass [12 and 24 months]

6. laboratory parameters [12 and 24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Sao Paulo - School of Medicine	Sao Paulo		Brazil	01246-903

Sponsors and Collaborators

• University of Sao Paulo
• AlzChem AG

Investigators

• Principal Investigator: Bruno Gualano, PhD, University of Sao Paulo
• Principal Investigator: Rosa M Pereira, PhD, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01472393
• Other Study ID Numbers: USP.BONE
• First Posted: Nov 16, 2011
• Last Update Posted: Jan 30, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Bruno Gualano, Professor, University of Sao Paulo: creatine supplementation; bone mass; postmenopausal women; muscle function; bone markers

Study Results

No Results Posted as of Jan 30, 2015