search
Back to results

The Effect of Exercise in Postmenopausal Women With Low Bone Density

Primary Purpose

Osteoporosis, Osteopenia

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Exercise, Low bone density, Falls

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Exercise performed at the gym and at home

Usual care no additional exercise

Outcomes

Primary Outcome Measures

Bone density measured using DXA at the lumbar spine and proximal femur

Secondary Outcome Measures

Falls risk factors

Full Information

First Posted
March 24, 2008
Last Updated
June 2, 2015
Sponsor
University of Melbourne
Collaborators
Swisse Vitamins Pty Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT00643331
Brief Title
The Effect of Exercise in Postmenopausal Women With Low Bone Density
Official Title
The Effect of Exercise in Postmenopausal Women With Low Bone Density
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Melbourne
Collaborators
Swisse Vitamins Pty Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
Osteoporosis, Exercise, Low bone density, Falls

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Exercise performed at the gym and at home
Arm Title
2
Arm Type
No Intervention
Arm Description
Usual care no additional exercise
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Exercise performed at gym and at home comprising strength, balance and impact exercise
Primary Outcome Measure Information:
Title
Bone density measured using DXA at the lumbar spine and proximal femur
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Falls risk factors
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim L Bennell, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3010
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

The Effect of Exercise in Postmenopausal Women With Low Bone Density

We'll reach out to this number within 24 hrs