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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

March 24, 2008
March 24, 2008
February 2001
November 2007   (final data collection date for primary outcome measure)
Bone density measured using DXA at the lumbar spine and proximal femur [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Falls risk factors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Exercise in Postmenopausal Women With Low Bone Density
The Effect of Exercise in Postmenopausal Women With Low Bone Density

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoporosis
  • Osteopenia
Behavioral: Exercise
Exercise performed at gym and at home comprising strength, balance and impact exercise
  • Experimental: 1
    Exercise performed at the gym and at home
    Intervention: Behavioral: Exercise
  • No Intervention: 2
    Usual care no additional exercise
    Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
November 2007
November 2007   (final data collection date for primary outcome measure)

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
Female
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00643331
2001.075
No
Professor Kim Bennell, University of Melbourne
University of Melbourne
Swisse Vitamins Pty Ltd
Principal Investigator: Kim L Bennell, PhD University of Melbourne
University of Melbourne
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP