The Effect of Exercise in Postmenopausal Women with Low Bone Density

NCT00643331 | Completed Phase 2

• 1 other identifier: 2001.075
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Bone density measured using DXA at the lumbar spine and proximal femur

  12 months

Secondary Outcomes (1)

• Falls risk factors

  12 months

Study Arms (2)

1

EXPERIMENTAL

Exercise performed at the gym and at home

Behavioral: Exercise

2

NO INTERVENTION

Usual care no additional exercise

Interventions

Exercise BEHAVIORAL

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

1

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Melbourne: lead
• Swisse Vitamins Pty Ltd: collaborator

Study Sites (1)

University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kim L Bennell, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: February 1, 2001
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: December 9, 2024

Record last verified: 2008-03

Locations

AU (1)