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The Effect of Exercise in Postmenopausal Women With Low Bone Density

This study has been completed.
Sponsor:
Collaborator:
Swisse Vitamins Pty Ltd
Information provided by:
University of Melbourne
ClinicalTrials.gov Identifier:
NCT00643331
First received: March 24, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention Phase
Osteoporosis
Osteopenia
 Behavioral: Exercise
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Exercise in Postmenopausal Women With Low Bone Density

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Melbourne:

Primary Outcome Measures:
  • Bone density measured using DXA at the lumbar spine and proximal femur [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Falls risk factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: February 2001
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Behavioral: Exercise
Exercise performed at gym and at home comprising strength, balance and impact exercise

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Professor Kim Bennell, University of Melbourne
ClinicalTrials.gov Identifier: NCT00643331     History of Changes
Other Study ID Numbers: 2001.075
Study First Received: March 24, 2008
Last Updated: March 24, 2008
Health Authority: Australia: Human Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013