Tai Chi for Osteopenic Women

Harvard University Faculty of Medicine

Status and phase

Unknown

Phase 2

Conditions

Osteopenia

Treatments

Other: Tai Chi

Other: Standard Care

Study type

Interventional

Funder types

Other

Identifiers

NCT01039012

R21AT003503

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

Female

Ages

45 to 70 years old

Volunteers

No Healthy Volunteers

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