Completed

Bone Estrogen Strength Training (BEST)

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What is being tested

Hormone replacement therapy

+ Strength training

DrugProcedure
Who is being recruted

Behavior+5

+ Bone Diseases

+ Bone Diseases, Metabolic

From 40 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: August 1995
See protocol details

Summary

Principal SponsorUniversity of Arizona
Last updated: May 20, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1995

Actual date on which the first participant was enrolled.

Osteoporotic fractures associated with low bone mineral density (BMD) are a significant public health problem for women, resulting in over 1 million fractures per year. The increasing incidence of fractures will make an already major health problem an even greater one in the future. Estimates of medical costs for the treatment of osteoporotic fractures are expected to increase from $14.8 billion in 1995 to $60 billion by 2020. Although the Women's Health Initiative is investigating dietary and hormonal factors in relation to bone density, it is not investigating the effects of exercise on reducing bone mineral loss in postmenopausal women. This study includes completion of a large, partially randomized clinical trial evaluating the effect of a 1-year exercise intervention on total body and regional BMD in two populations (hormone replacement therapy [HRT] versus no HRT) of postmenopausal women with a previous history of physical inactivity. A major hypothesis is that, compared to the no-exercise group, the exercise intervention will be an effective alternative to reduce the risk of osteoporosis and the exercise effects will be larger in the cohort of women on HRT than those not on HRT. The exercise program includes progressive resistance exercises using free weights and weight resistance machines and weight-bearing aerobic exercises. We carefully supervise and monitor the exercise compliance by keeping records of the amount of exercise completed at each of three weekly exercise sessions and by measuring strength gains of selected muscle groups. We will measure biochemical markers of bone formation and resorption and hormonal correlates of bone mineral density changes including sex steroids at baseline, 6 months, and 1 year. We have obtained duplicate blood collections, made one week apart, for all cohorts at each of the three measurement periods. We have also collected duplicate dual energy x-ray absorptiometry (DXA) scans at each time period to follow changes in axial and appendicular BMD and total and regional soft tissue body composition as a result of the intervention. We collected extensive dietary intake records during the first year of intervention; we will monitor dietary intake in a 2-year followup using food frequency questionnaires. We will also measure followup BMD, soft tissue, and lean and fat body composition for 2 years in all women who complete the first-year intervention program. Two-hundred sixty-six women have completed the first year of the intervention. The study has a retention rate of 92 percent in the first year for the first four cohorts. Because of the paucity of information regarding long-term effects of exercise, and because of the increased emphasis in the scientific community on evaluating the long-term efficacy of exercise interventions for osteoporosis prevention, this comprehensive 1-year clinical trial and 2-year followup will make an important contribution to determining the future role of combining progressive resistance and weight bearing aerobic exercise in the prevention of osteoporosis in two populations (HRT vs. no HRT) of postmenopausal women.

NCT00000399
Principal SponsorUniversity of Arizona
Last updated: May 20, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesMotor ActivityOsteoporosis

Criteria

6 inclusion criteria required to participate
Age 40-65 years

Cancer free for the last 5 years (treatment free for last 5 years) excluding skin cancers

Nonsmoker

Post-menopausal females, 3-10 years past menopause (natural or surgical menopause); if subjects are currently taking hormone replacement therapy (HRT), they must be taking HRT for at least 1 year but no more than 6 years. The subjects must be relatively sedentary, not currently engaged in strength-training exercises

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5 exclusion criteria prevent from participating
Amount of physical activity exceeds 120 minutes of moderate exercise per week. Moderate exercise examples: brisk walking, golfing, gardening, housework, house painting. Potential subject cannot be weight lifting

Currently participating in any other research study

Currently taking beta-blockers or steroids in large quantities/frequencies

Currently taking medications that control cholesterol or alter bone mineral density

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Ina Gittings Bldg. Body Composition Laboratory

Tucson, United StatesOpen Ina Gittings Bldg. Body Composition Laboratory in Google Maps
CompletedOne Study Center