The Effect of Exercise in Postmenopausal Women with Low Bone Density

Phase 2

Completed

• Conditions: Osteoporosis; Osteopenia
• Interventions: Behavioral: Exercise

• Registration Number: NCT00643331
• Lead Sponsor: University of Melbourne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2008-03
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-26
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Exercise	Exercise performed at the gym and at home

Primary Outcome Measures

Name	Time	Method
Bone density measured using DXA at the lumbar spine and proximal femur	12 months

Secondary Outcome Measures

Name	Time	Method
Falls risk factors	12 months

Trial Locations

Locations (1)

University of Melbourne; 🇦🇺 Melbourne, Victoria, Australia