OsteoporosisPhase 2NCT00000399
Bone Estrogen Strength Training
A Phase 2 study testing Hormone replacement therapy and Strength training in people with Osteoporosis, run by University of Arizona at 1 site in United States.
Trial summary
We started the Bone, Estrogen, Strength Training (BEST) study in the fall of 1995 at the University of Arizona, Tucson, Arizona. The BEST study is the largest of its kind. It looks at the effects of hormone replacement therapy and strength training exercise on bone mineral density. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Hormone replacement therapy and Strength training
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1995to Jan 2001
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-65 years.
- Post-menopause (3-10.9 years) due to hysterectomy or natural menopause.
- 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.
- Nonsmoker.
- Cancer free for the last 5 years (treatment free for last 5 years) excluding skin cancers.
- Resident of Tucson (48 out of 52 weeks of year).
Who cannot join
- History of bone fractures or currently have osteoporosis.
- Currently taking medications that control cholesterol or alter bone mineral density.
- Currently taking beta-blockers or steroids in large quantities/frequencies.
- Currently participating in any other research study.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ina Gittings Bldg. Body Composition Laboratory
Tucson, Arizona, 85721
About this study
Official title: Bone Estrogen Strength Training (BEST)
We started the Bone, Estrogen, Strength Training (BEST) study in the fall of 1995 at the University of Arizona, Tucson, Arizona. The BEST study is the largest of its kind. It looks at the effects of hormone replacement therapy and strength training exercise on bone mineral density. (Bone mineral density affects bone strength and the risk of osteoporosis.) Six groups of about 300 women each participated in this osteoporosis prevention study. In 1998, the BEST study received additional funding to examine for another 2 years the long-term effects of strength training on bone mineral density. By 2001 we will have finished analyzing the results for all study groups on the 1-year effects of exercise on bone, as well as additional analyses on the effects of 2, 3, and 4 years of strength training and weight-bearing exercise on bone.
Read the detailed description
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.
- Conditions
- Osteoporosis
- Being tested
- Hormone replacement therapy, Strength training
- Keywords
- Estrogen, Hormone therapy, Strength training, Exercise, Postmenopause, Disorder prevention, Osteoporosis, Bone mineral density, Bone mass, Cholesterol, Body composition
- Medical subject headings
- Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone replacement therapyDrug
Strength trainingProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startAug 1995
- Study completionJan 2001
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 OsteoporosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Timothy G. Lohman, PhD, Principal investigator, University of Arizona College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000399
- Sponsor's protocol ID
- R01AR039559
- Other IDs
- R01AR039559, NIAMS-006
- Status last verified
- May 2013
- First submitted
- 3 Nov 1999
- Last updated
- 20 May 2013
- Results posted
- No
Publications
Harris MM, Houtkooper LB, Stanford VA, Parkhill C, Weber JL, Flint-Wagner H, Weiss L, Going SB, Lohman TG. Dietary iron is associated with bone mineral density in healthy postmenopausal women. J Nutr. 2003 Nov;133(11):3598-602. doi: 10.1093/jn/133.11.3598.
PubMed 14608080Harris M, Farrell V, Houtkooper L, Going S, Lohman T. Associations of polyunsaturated Fatty Acid intake with bone mineral density in postmenopausal women. J Osteoporos. 2015;2015:737521. doi: 10.1155/2015/737521. Epub 2015 Feb 17.
PubMed 25785226
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Estrogen Strength Training (BEST)
- ClinicalTrials.gov ID
- NCT00000399
- Acronym / sponsor ID
- R01AR039559
- Conditions
- Osteoporosis
- Keywords
- Estrogen, Hormone therapy, Strength training, Exercise, Postmenopause, Disorder prevention, Osteoporosis, Bone mineral density
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Aug 1995
- Study completion
- Jan 2001
- First posted
- 4 Nov 1999 (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.
We started the Bone, Estrogen, Strength Training (BEST) study in the fall of 1995 at the University of Arizona, Tucson, Arizona. The BEST study is the largest of its kind. It looks at the effects of hormone replacement therapy and strength training exercise on bone mineral density. (Bone mineral density affects bone strength and the risk of osteoporosis.) Six groups of about 300 women each participated in this osteoporosis prevention study. In 1998, the BEST study received additional funding to examine for another 2 years the long-term effects of strength training on bone mineral density. By 2001 we will have finished analyzing the results for all study groups on the 1-year effects of exercise on bone, as well as additional analyses on the effects of 2, 3, and 4 years of strength training and weight-bearing exercise on bone.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 40-65 years.
- Post-menopause (3-10.9 years) due to hysterectomy or natural menopause.
- 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.
- Nonsmoker.
- Cancer free for the last 5 years (treatment free for last 5 years) excluding skin cancers.
Key exclusion criteria (5 listed)
- History of bone fractures or currently have osteoporosis.
- Currently taking medications that control cholesterol or alter bone mineral density.
- Currently taking beta-blockers or steroids in large quantities/frequencies.
- Currently participating in any other research study.
- 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.
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 |
|---|---|---|
| Hormone replacement therapy | Drug | – |
| Strength training | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2013.
- Background: PubMed 14608080Harris MM, Houtkooper LB, Stanford VA, Parkhill C, Weber JL, Flint-Wagner H, Weiss L, Going SB, Lohman TG. Dietary iron is associated with bone mineral density in healthy postmenopausal women. J Nutr. 2003 Nov;133(11):3598-602. doi: 10.1093/jn/133.11.3598.
- Derived from this study: PubMed 25785226Harris M, Farrell V, Houtkooper L, Going S, Lohman T. Associations of polyunsaturated Fatty Acid intake with bone mineral density in postmenopausal women. J Osteoporos. 2015;2015:737521. doi: 10.1155/2015/737521. Epub 2015 Feb 17.
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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.
Timothy G. Lohman, PhD principal investigator
University of Arizona College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hormone replacement therapy and Strength training in people with Osteoporosis, run by University of Arizona at 1 site 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 20 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000399, 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 20 May 2013.