OsteopeniaPhase 2NCT01039012
Tai Chi for Osteopenic Women
A Phase 2 study testing Tai Chi in people with Osteopenia, run by Harvard University Faculty of Medicine at 2 sites in United States.
Trial summary
This study will assess the effectiveness of Tai Chi to affect the rate of bone loss in post-menopausal women who have been diagnosed with the initial stages of bone thinning. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- Tai Chi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages 45-70 years
- BMD T-scores of the hip (femoral neck or trochanter) and/or spine between -1.0 and -2.5
- Post-menopausal w/out menses for ≥ 12 months
- Sedentary, i.e. do not regularly participate in physical exercise on average 1 or more times per week
Who cannot join
- Osteoporotic (T-score < -2.5) or a fracture in the past 2 years not caused by motor vehicle accident
- Prior or current use of use of medication that increase risks of fracture (e.g. steroids, anti-convulsants, anticoagulants, lithium)
- Prior or current use of medications that modify bone metabolism (e.g. bisphosphonates, selective estrogen receptor modulators such as Raloxifene)
- Use of calcium supplements above levels suggested within the recommendations of standard care (i.e., above 1200-1500 mg)
- Current or prior year use of estrogen or calcitonin
- Malignancies other than skin cancer
Show all 12Show fewer
- Diagnosis of anorexia along with a BMI of < 17.5
- Conditions that cause secondary osteoporosis (e.g. Cushing's syndrome, Marfan's syndrome)
- Tobacco use in past year
- Physical or mental disabilities that will preclude informed consent or active study participation
- Geographic or scheduling limitations that would preclude required participation in weekly Tai Chi classes and study procedures
- Current regular practice of Tai Chi
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Tai Chi for Osteopenic Women: A Pilot Randomized Controlled Trial
This study will assess the effectiveness of Tai Chi to affect the rate of bone loss in post-menopausal women who have been diagnosed with the initial stages of bone thinning.
Read the detailed description
Osteopenia is a serious and growing public health concern for women. Osteopenic women are at greater risk for fractures than women with normal bone mineral densities (BMD). Low BMD-related fractures are associated with significant long-term impairment, high morbidity rates and high medical costs. Optimal preventive and sustainable interventions for osteopenic women are not yet well-defined.
Tai Chi, a mind-body exercise that is growing in popularity in the U.S., shows may be an effective, safe and practical intervention for women with low bone density. Preliminary studies suggest Tai Chi can reduce rates of BMD decline in post-menopausal women. While suggestive, these studies have numerous design limitations.
We propose a pilot randomized controlled trial to assess the efficacy and feasibility of Tai Chi as an adjunct to standard care for post-menopausal osteopenic women. Eight-six osteopenic women ages 45-70 will be recruited from a large multi-specialty group practice. Our primary aim is to assess the feasibility for recruiting and retaining osteopenic women into a randomized controlled trial of 9 months of Tai Chi. Our secondary aim is to collect preliminary data on the efficacy of Tai Chi in reducing rates of bone loss in osteopenic women using sensitive markers of bone turnover and dual-energy x-ray absorptiometry. The results of this study will inform the design of a future trial evaluating the benefits and safety for Tai Chi for osteopenic women, as well as the physiological and biomechanical mechanisms through which Tai Chi may impact BMD and fracture risks associated with osteopenia.
- Conditions
- Osteopenia
- Being tested
- Tai Chi, Standard Care
- Keywords
- bone mineral density, osteoporosis, exercise, bone remodeling, biomotion analysis
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiOther
Participants randomized to the Tai Chi group select a Tai Chi school from a pre-screened list of community-based Tai Chi programs and enroll for 9 months. Participants are asked to attend classes twice a week for the first month and once a week for the remaining 8 months. They are also asked to practice at home, or attend more classes for 2-3 additional hours per week. While in the study they are also encouraged to follow the standard care as recommended by their physician.
Standard CareOther
Participant follow the standard care recommended by their physician.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi plus Standard Care | Other | Not described Receives: Other: Tai Chi |
| Standard Care | Other | Not described Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum markers of bone resorption (CTX, C-terminal cross linking telopeptide of type I collagen), and bone formation (osteocalcin).
Measured: Baseline, 3 months, 9 months
Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry).
Measured: Baseline, 9 months
Secondary outcomes (1)
Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n=16).
Measured: Baseline, 3 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startJan 2008
- Primary completionFeb 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University Faculty of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039012
- Sponsor's protocol ID
- R21AT003503
- Status last verified
- Dec 2009
- First submitted
- 22 Dec 2009
- Last updated
- 24 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Wayne PM, Kiel DP, Buring JE, Connors EM, Bonato P, Yeh GY, Cohen CJ, Mancinelli C, Davis RB. Impact of Tai Chi exercise on multiple fracture-related risk factors in post-menopausal osteopenic women: a pilot pragmatic, randomized trial. BMC Complement Altern Med. 2012 Jan 30;12:7. doi: 10.1186/1472-6882-12-7.
PubMed 22289280Wayne PM, Buring JE, Davis RB, Connors EM, Bonato P, Patritti B, Fischer M, Yeh GY, Cohen CJ, Carroll D, Kiel DP. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2010 Mar 1;11:40. doi: 10.1186/1471-2474-11-40.
PubMed 20193083
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi for Osteopenic Women: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01039012
- Acronym / sponsor ID
- R21AT003503
- Conditions
- Osteopenia
- Keywords
- bone mineral density, osteoporosis, exercise, bone remodeling, biomotion analysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Harvard University Faculty of MedicineUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the effectiveness of Tai Chi to affect the rate of bone loss in post-menopausal women who have been diagnosed with the initial stages of bone thinning.
Detailed description
Osteopenia is a serious and growing public health concern for women. Osteopenic women are at greater risk for fractures than women with normal bone mineral densities (BMD). Low BMD-related fractures are associated with significant long-term impairment, high morbidity rates and high medical costs. Optimal preventive and sustainable interventions for osteopenic women are not yet well-defined.
Tai Chi, a mind-body exercise that is growing in popularity in the U.S., shows may be an effective, safe and practical intervention for women with low bone density. Preliminary studies suggest Tai Chi can reduce rates of BMD decline in post-menopausal women. While suggestive, these studies have numerous design limitations.
We propose a pilot randomized controlled trial to assess the efficacy and feasibility of Tai Chi as an adjunct to standard care for post-menopausal osteopenic women. Eight-six osteopenic women ages 45-70 will be recruited from a large multi-specialty group practice. Our primary aim is to assess the feasibility for recruiting and retaining osteopenic women into a randomized controlled trial of 9 months of Tai Chi. Our secondary aim is to collect preliminary data on the efficacy of Tai Chi in reducing rates of bone loss in osteopenic women using sensitive markers of bone turnover and dual-energy x-ray absorptiometry. The results of this study will inform the design of a future trial evaluating the benefits and safety for Tai Chi for osteopenic women, as well as the physiological and biomechanical mechanisms through which Tai Chi may impact BMD and fracture risks associated with osteopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi plus Standard Care | Other | Other: Tai Chi |
| Standard Care | Other | Other: Standard Care |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women ages 45-70 years
- BMD T-scores of the hip (femoral neck or trochanter) and/or spine between -1.0 and -2.5
- Post-menopausal w/out menses for ≥ 12 months
- Sedentary, i.e. do not regularly participate in physical exercise on average 1 or more times per week
Key exclusion criteria (12 listed)
- Osteoporotic (T-score < -2.5) or a fracture in the past 2 years not caused by motor vehicle accident
- Prior or current use of use of medication that increase risks of fracture (e.g. steroids, anti-convulsants, anticoagulants, lithium)
- Prior or current use of medications that modify bone metabolism (e.g. bisphosphonates, selective estrogen receptor modulators such as Raloxifene)
- Use of calcium supplements above levels suggested within the recommendations of standard care (i.e., above 1200-1500 mg)
- Current or prior year use of estrogen or calcitonin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiParticipants randomized to the Tai Chi group select a Tai Chi school from a pre-screened list of community-based Tai Chi programs and enroll for 9 months. Participants are asked to attend classes twice a week for the first month and once a week for the remaining 8 months. They are also asked to practice at home, or attend more classes for 2-3 additional hours per week. While in the study they are also encouraged to follow the standard care as recommended by their physician. | Other | Tai Chi plus Standard Care |
| Standard CareParticipant follow the standard care recommended by their physician. | Other | Standard Care |
Primary outcome
Serum markers of bone resorption (CTX, C-terminal cross linking telopeptide of type I collagen), and bone formation (osteocalcin).
Time frame: Baseline, 3 months, 9 months
Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry).
Time frame: Baseline, 9 months
1 secondary outcome
Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n=16).
Time frame: Baseline, 3 months, 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2009.
- Derived from this study: PubMed 22289280Wayne PM, Kiel DP, Buring JE, Connors EM, Bonato P, Yeh GY, Cohen CJ, Mancinelli C, Davis RB. Impact of Tai Chi exercise on multiple fracture-related risk factors in post-menopausal osteopenic women: a pilot pragmatic, randomized trial. BMC Complement Altern Med. 2012 Jan 30;12:7. doi: 10.1186/1472-6882-12-7.
- Derived from this study: PubMed 20193083Wayne PM, Buring JE, Davis RB, Connors EM, Bonato P, Patritti B, Fischer M, Yeh GY, Cohen CJ, Carroll D, Kiel DP. Tai Chi for osteopenic women: design and rationale of a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2010 Mar 1;11:40. doi: 10.1186/1471-2474-11-40.
Related trials for Osteopenia
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tai Chi in people with Osteopenia, run by Harvard University Faculty of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum markers of bone resorption (CTX, C-terminal cross linking telopeptide of type I collagen), and bone formation (osteocalcin). (time frame: Baseline, 3 months, 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01039012, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2009.