CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 171 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
Placebo 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00625391
NCT00625391Phase 2Completed

GTP and Tai Chi for Bone Health: a Pilot Study

Texas Tech University Health Sciences Center·interventional·Posted Feb 28, 2008·Updated Aug 18, 2014

In Brief

A Phase 2 clinical trial evaluating Placebo, Green Tea Polyphenols (GTP), and 2 other interventions for Osteoporosis. Completed, enrolled 171 participants across 1 site.

Detailed Summary

Osteoporosis is a major health problem in postmenopausal women. Our long-term goal is to develop a new alternative treatment that include a dietary supplement (green tea extract) and a mind-body exercise (Tai Chi) for lessening bone loss in postmenopausal women with low bone mass. A combination of dietary supplement and moderate intensity exercise now becomes a new alternative treatment in reducing bone loss in postmenopausal women with low bone mass, due to the possible stronger effects of the combination than individual treatments. Objective: To test a CAM intervention including green tea polyphenol (GTP) and Tai Chi (TC) exercise for feasibility, and to quantitatively assess their individual and conjugate effects on postmenopausal women with osteopenia. Hypotheses: (1) 24 weeks of GTP supplement, TC exercise, and their combination will benefit bone remodeling as measured by bone biomarkers and muscle strength/physical function in postmenopausal women with osteopenia compared to those receiving placebo only, and (2) the changes in bone biomarkers associated with bone remodeling will be correlated with the changes in oxidative stress.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 28, 2008
Enrollment StartFeb 1, 2008
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.3 years ago

Interventions

Placebodrug

500 mg medicinal starch pills daily

Green Tea Polyphenols (GTP)drug

500 mg green tea polyphenols daily

Placebo+Tai Chi (TC)drug

500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks

GTP+TCdrug

500 mg GTP daily plus TC exercise (3x/week) for 24 weeks