The Effect of Exercise in Postmenopausal Women with Low Bone Density

NCT ID: NCT00643331

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2007-11-30

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.

Conditions

Osteoporosis; Osteopenia

Keywords

Osteoporosis; Exercise; Low bone density; Falls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Exercise performed at the gym and at home

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Exercise performed at gym and at home comprising strength, balance and impact exercise

2

Usual care no additional exercise

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

Exercise performed at gym and at home comprising strength, balance and impact exercise

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swisse Vitamins Pty Ltd

UNKNOWN

Sponsor Role: collaborator

University of Melbourne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim L Bennell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

University of Melbourne

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

2001.075

Identifier Type: -

Identifier Source: org_study_id