Clinical trial NCT01039012: Tai Chi for Osteopenic Women
Official title: Tai Chi for Osteopenic Women: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteopenia
Keywords: bone mineral density
osteoporosis
exercise
bone remodeling
biomotion analysis
Lead sponsor: Harvard University Faculty of Medicine
Sponsor class: OTHER
First posted: 2009-12-24
Enrollment: 86
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Serum markers of bone resorption (CTX, C-terminal cross linking telopeptide of type I collagen), and bone formation (osteocalcin).
timeFrame: Baseline, 3 months, 9 months
measure: Bone mass density of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry).
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: 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).
timeFrame: Baseline, 3 months, 9 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
citation: 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.
citation: Wayne 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.