Green Tea and Tai Chi for Bone Health

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This is a 24-week, randomized, and placebo-controlled intervention trial to investigate the effects of green tea polyphenols (GTP) and Tai Chi (TC) on relevant primary and secondary endpoints in postmenopausal women with osteopenia. Women at least 2 years after menopause, with osteopenia, will be recruited primarily from local senior independent/assisted living facilities, municipal senior community centers, and obstetrics and gynecology clinics. After screening, qualified participants will be matched for age and will be randomly assigned to one of the four treatment groups: placebo, GTP, placebo+TC, and GTP+TC. During the 24-week intervention, all participants will be provided with calcium and vitamin D daily. The participants in the placebo group will receive medicinal starch for 24 weeks. The GTP participants will receive GTP for 24 weeks. The placebo+TC participants will receive both placebo and TC treatments for 24 weeks. The GTP+TC participants will receive both GTP and TC treatments for 24 weeks. Participants will receive the primary and secondary outcome measures at baseline, 4, 12, and 24 weeks. The primary outcome measures are concentrations of bone biomarkers. The secondary outcome measure is a biomarker of oxidative stress DNA damage. Additional secondary outcome is muscle strength/physical function. Investigators evaluating the endpoints will be blinded to intervention allocation.

Official Title
-----------------
GTP and Tai Chi for Bone Health: a Pilot Study

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Green Tea Polyphenols (GTP)
* Drug: Placebo+Tai Chi (TC)
* Drug: GTP+TC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women at least 2 years after menopause (to ensure established postmenopausal status). Sedentary at baseline. Normal laboratory evaluation, thyroid function, hepatic function, renal function. Osteopenia. Exclusion Criteria: History of scoliosis, severe osteoarthritis, etc., or other spinal disease that may result in anatomy unsuitable for accurate bone densitometry. History of cancer with some exceptions. History of metabolic bone disease. Having used anabolic steroids, calcitonin, calcitriol, alfacalcidol, etc. Fluoride treatment at a dose greater than 1 mg/day any time. History of glucocorticoid treatment. Any previous treatment with bisphosphonates. Uncontrolled intercurrent illness such as symptomatic congestive heart failure, myocardial infarction or stroke, hypertension, or terminal illness. Physical conditions that preclude participation of exercise intervention. Cognitive impairment. Depression. History of malabsorption syndrome and uncontrolled diabetes mellitus.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo pill<br>24 weeks of placebo. | Drug: Placebo<br>* 500 mg medicinal starch pills daily<br>* Other names: Placebo control group;|
| Active Comparator: Green Tea Polyphenols (GTP)<br>24 weeks of green tea polyphenols | Drug: Green Tea Polyphenols (GTP)<br>* 500 mg green tea polyphenols daily<br>* Other names: Green tea polyphenols group;|
| Active Comparator: Placebo+Tai Chi (TC)<br>24 weeks of placebo plus Tai Chi exercise. | Drug: Placebo+Tai Chi (TC)<br>* 500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks<br>* Other names: Placebo plus tai chi exercise group;|
| Active Comparator: GTP+TC<br>24 weeks of green tea polyphenols plus Tai Chi exercise. | Drug: GTP+TC<br>* 500 mg GTP daily plus TC exercise (3x/week) for 24 weeks<br>* Other names: Green tea polyphenols plus tai chi exercise group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker | Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP) | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative Stress Damage Biomarker | Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postmenopausal, bone, dietary supplement, mind-body exercise