NCT00000399

Brief 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. (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 1995

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1995

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2001

Completed
Last Updated

May 20, 2013

Status Verified

May 1, 2013

First QC Date

November 3, 1999

Last Update Submit

May 17, 2013

Conditions

Osteoporosis

Keywords

EstrogenHormone therapyStrength trainingExercisePostmenopauseDisorder preventionOsteoporosisBone mineral densityBone massCholesterolBody composition

Interventions

Hormone replacement therapyDRUG
Strength trainingPROCEDURE

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ina Gittings Bldg. Body Composition Laboratory

Tucson, Arizona, 85721, United States

Location

Related Publications (2)

  • 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.

    PMID: 14608080BACKGROUND

  • Harris 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.

    PMID: 25785226DERIVED

MeSH Terms

Conditions

OsteoporosisMotor Activity

Interventions

Hormone Replacement TherapyResistance Training

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Timothy G. Lohman, PhD

    University of Arizona College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 1, 1995

Study Completion

January 1, 2001

Last Updated

May 20, 2013

Record last verified: 2013-05

Locations

US(1)