The Effect of Exercise in Postmenopausal Women With Low Bone Density

Osteoporosis Clinical Trial

Official title:

The Effect of Exercise in Postmenopausal Women With Low Bone Density

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643331
• Other study ID #: 2001.075
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2008
• Last updated: June 2, 2015
• Start date: February 2001
• Est. completion date: November 2007

Study information

• Verified date: March 2008
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Australia	University of Melbourne	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
University of Melbourne	Swisse Vitamins Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone density measured using DXA at the lumbar spine and proximal femur		12 months	No
Secondary	Falls risk factors		12 months	No