The Effect of Exercise in Postmenopausal Women With Low Bone Density

June 2, 2015 updated by: University of Melbourne
This clinical trial aims to evaluate the effects of a 12 month gym- and home-based exercise program on bone density and falls risk factors in postmenopausal women with low bone density. It is hypothesised that the exercise program will lead to improvements in bone density and falls risk factors such as balance and muscle strength compared with usual care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3010
        • University of Melbourne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Be aged greater than 50 years
  • Be at least 5 years post menopause (defined as the last normal menstrual bleed)
  • Have osteopenia of the hip defined as a DXA T-score between -1 and -2.5 in one or more regions of the proximal femur (total hip, neck or trochanter regions).
  • Have primary osteopenia
  • Be community dwelling (not in residential care)
  • Be able to attend an exercise program 3 times per week over the 12-month period
  • Be able to read and write English

Exclusion Criteria:

  • Secondary causes of bone loss such as osteomalacia, glucocorticoid medication
  • Co-morbidities that would interfere with participation in exercise such as severe heart or pulmonary disease, inflammatory joint disease, severe osteoarthritis, psychiatric condition
  • Physical or orthopaedic disabilities that would place the subject at risk or limit their ability to perform exercise
  • Spinal osteoporosis defined as DXA T-score <-2.5
  • A past vertebral fracture
  • Body mass index > 35 or < 18.
  • Currently on hormone replacement therapy (HRT)
  • Current smoker
  • Past use of HRT within the past 3 years and for more than 6 months duration
  • Taking medication known to affect bone including oestrogen or steroid hormones
  • Known clinically significant liver or renal disease
  • Cancer within the past 5 years
  • Doing regular strength training and/or weight-bearing exercise at least once per week in past 6 months
  • Unlikely to comply with the intervention protocol

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Exercise performed at the gym and at home
Behavioral: Exercise
Exercise performed at gym and at home comprising strength, balance and impact exercise
No Intervention: 2
Usual care no additional exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone density measured using DXA at the lumbar spine and proximal femur
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Falls risk factors
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Collaborators

Swisse Vitamins Pty Ltd

Investigators

  • Principal Investigator: Kim L Bennell, PhD, University of Melbourne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001.075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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