Green Tea and Tai Chi for Bone Health (GTP-TC-Bone)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Leslie Shen, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00625391
First received: February 26, 2008
Last updated: August 1, 2014
Last verified: August 2014
Results First Received: December 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Osteoporosis
Interventions: Drug: Placebo
Drug: Green Tea Polyphenols (GTP)
Drug: Placebo+Tai Chi (TC)
Drug: GTP+TC

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: March 2008 - December 2008. Location: community setting

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no any significant events arranged.

Reporting Groups
  Description
Placebo Group Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
Green Tea Polyphenols (GTP) Group Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
Placebo + Tai Chi Group Placebo+Tai Chi group receiving both placebo treatment and Tai Chi training (60-minute group exercise, 3 times per week)for 24 weeks.
GTP + Tai Chi Group GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.

Participant Flow:   Overall Study
    Placebo Group     Green Tea Polyphenols (GTP) Group     Placebo + Tai Chi Group     GTP + Tai Chi Group  
STARTED     44     47     42     38  
COMPLETED     37     39     37     37  
NOT COMPLETED     7     8     5     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Placebo group receiving 500 mg medicinal starch daily for 24 weeks.
Green Tea Polyphenols (GTP) Green tea polyphenols (GTP) group receiving 500 mg of GTP per day for 24 weeks.
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.
GTP+Tai Chi GTP+Tai Chi group receiving both GTP and Tai Chi training for 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Green Tea Polyphenols (GTP)     Placebo+Tai Chi     GTP+Tai Chi     Total  
Number of Participants  
[units: participants]
  44     47     42     38     171  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     38     42     36     33     149  
>=65 years     6     5     6     5     22  
Age  
[units: years]
Mean ± Standard Deviation
  57.6  ± 7.5     56.5  ± 5.5     58.3  ± 7.7     57.6  ± 6.7     57.4  ± 6.9  
Gender  
[units: participants]
         
Female     44     47     42     38     171  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     44     47     42     38     171  



  Outcome Measures
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1.  Primary:   Change From Baseline (100%) in Ratio of Bone Formation Marker to Bone Resorption Marker   [ Time Frame: 24 weeks ]

2.  Secondary:   Oxidative Stress Damage Biomarker   [ Time Frame: 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitation of this study included: (1) the number of subjects in each group at the baseline was not equal. (2) The amount of dietary calcium intake for each subject was not available.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Chwan-Li Shen
Organization: Texas Tech University Health Sciences Center
phone: (806) 743-2815
e-mail: Leslie.Shen@ttuhsc.edu


Publications of Results:
Other Publications:

Responsible Party: Leslie Shen, Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00625391     History of Changes
Other Study ID Numbers: R21 AT003735-01A1, R21AT003735-01A1
Study First Received: February 26, 2008
Results First Received: December 5, 2012
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration