Osteoporosis
Conditions
Keywords
postmenopausal, bone, dietary supplement, mind-body exercise
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.
Interventions
DRUGPlacebo
500 mg medicinal starch pills daily
DRUGGreen Tea Polyphenols (GTP)
500 mg green tea polyphenols daily
DRUGPlacebo+Tai Chi (TC)
500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks
DRUGGTP+TC
500 mg GTP daily plus TC exercise (3x/week) for 24 weeks
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker | 24 weeks | Bone formation biomarker: bone-specific alkaline phosphatase (BAP) Bone resorption biomarker: tartrate-resistant acid phosphatase (TRAP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative Stress Damage Biomarker | 24 weeks | Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test |
Countries
United States
Participant flow
Recruitment details
Recruitment period: March 2008 - December 2008. Location: community setting
Pre-assignment details
There was no any significant events arranged.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo group receiving 500 mg medicinal starch daily for 24 weeks. | 44 |
| Green Tea Polyphenols (GTP) Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks. | 47 |
| Placebo+Tai Chi Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks. | 42 |
| GTP+Tai Chi GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks. | 38 |
| Total | 171 |
Baseline characteristics
| Characteristic | Green Tea Polyphenols (GTP) | Placebo+Tai Chi | Placebo | GTP+Tai Chi | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 6 Participants | 5 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 36 Participants | 38 Participants | 33 Participants | 149 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 5.5 | 58.3 years STANDARD_DEVIATION 7.7 | 57.6 years STANDARD_DEVIATION 7.5 | 57.6 years STANDARD_DEVIATION 6.7 | 57.4 years STANDARD_DEVIATION 6.9 |
| Region of Enrollment United States | 47 participants | 42 participants | 44 participants | 38 participants | 171 participants |
| Sex: Female, Male Female | 47 Participants | 42 Participants | 44 Participants | 38 Participants | 171 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 37 |
Outcome results
Primary
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)
Time frame: 24 weeks
Population: Analyzed on those who completed the study. Percent change relative to the baseline for each group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker | 106.1 percentage change from baseline | Standard Deviation 3.7 |
| Green Tea Polyphenols | Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker | 103.6 percentage change from baseline | Standard Deviation 2.9 |
| Placebo + Tai Chi | Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker | 112.3 percentage change from baseline | Standard Deviation 3 |
| Green Tea Polyphenol + Tai Chi | Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker | 113.0 percentage change from baseline | Standard Deviation 3 |
Secondary
Oxidative Stress Damage Biomarker
Oxidative stress damage biomarker: urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG) test
Time frame: 24 weeks
Population: Analyzed who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Oxidative Stress Damage Biomarker | 73.5 ng/mg creatinine | Standard Deviation 50.9 |
| Green Tea Polyphenols | Oxidative Stress Damage Biomarker | 33.5 ng/mg creatinine | Standard Deviation 33.1 |
| Placebo + Tai Chi | Oxidative Stress Damage Biomarker | 29.7 ng/mg creatinine | Standard Deviation 21.9 |
| Green Tea Polyphenol + Tai Chi | Oxidative Stress Damage Biomarker | 20.6 ng/mg creatinine | Standard Deviation 19.8 |