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The Effect of Exercise in Postmenopausal Women With Low Bone Density

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00643331
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Behavioral: Exercise Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Exercise in Postmenopausal Women With Low Bone Density
Study Start Date : February 2001
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Bone density measured using DXA at the lumbar spine and proximal femur [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Falls risk factors [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643331


Locations
Australia, Victoria
University of Melbourne
Melbourne, Victoria, Australia, 3010
Sponsors and Collaborators
University of Melbourne
Swisse Vitamins Pty Ltd
Investigators
Principal Investigator: Kim L Bennell, PhD University of Melbourne
More Information

Responsible Party: Professor Kim Bennell, University of Melbourne
ClinicalTrials.gov Identifier: NCT00643331     History of Changes
Other Study ID Numbers: 2001.075
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: March 2008

Keywords provided by University of Melbourne:
Osteoporosis
Exercise
Low bone density
Falls

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases