Phase 2
N=171
Green Tea and Tai Chi for Bone Health
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00625391 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker — 106.1; 103.6; 112.3; 113.0 percentage change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Green Tea Polyphenols (GTP) (Drug); Placebo+Tai Chi (TC) (Drug); GTP+TC (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Texas Tech University Health Sciences Center
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker |
106.1; 103.6; 112.3; 113.0 | — |
| SECONDARY Oxidative Stress Damage Biomarker |
73.5; 33.5; 29.7; 20.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00625391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.