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The Effect of Exercise in Postmenopausal Women with Low Bone Density

U

University of Melbourne

Status and phase

Completed
Phase 2

Conditions

Osteopenia
Osteoporosis

Treatments

Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT00643331
2001.075

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

Female

Ages

50+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

38 participants in 2 patient groups

1
Experimental group
Description:
Exercise performed at the gym and at home
Treatment:
Behavioral: Exercise
2
No Intervention group
Description:
Usual care no additional exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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