OsteoporosisPhase 2NCT00643331
The Effect of Exercise in Postmenopausal Women with Low Bone Density
A Phase 2 study testing Exercise in people with Osteoporosis and Osteopenia, run by University of Melbourne at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2001to Nov 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Exercise
- Keywords
- Osteoporosis, Exercise, Low bone density, Falls
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Exercise performed at gym and at home comprising strength, balance and impact exercise
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise performed at the gym and at home Receives: Behavioral: Exercise |
| 2 | No intervention | Usual care no additional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone density measured using DXA at the lumbar spine and proximal femur
Measured: 12 months
Secondary outcomes (1)
Falls risk factors
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startFeb 2001
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Swisse Vitamins Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Kim L Bennell, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643331
- Sponsor's protocol ID
- 2001.075
- Status last verified
- Mar 2008
- First submitted
- 24 Mar 2008
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise in Postmenopausal Women with Low Bone Density
- ClinicalTrials.gov ID
- NCT00643331
- Acronym / sponsor ID
- 2001.075
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Osteoporosis, Exercise, Low bone density, Falls
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Swisse Vitamins Pty Ltd
- Study start
- Feb 2001
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: ExerciseExercise performed at the gym and at home |
| 2 | No intervention | –Usual care no additional exercise |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise performed at gym and at home comprising strength, balance and impact exercise | Behavioural | 1 |
Primary outcome
Bone density measured using DXA at the lumbar spine and proximal femur
Time frame: 12 months
1 secondary outcome
Falls risk factors
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim L Bennell, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise in people with Osteoporosis and Osteopenia, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone density measured using DXA at the lumbar spine and proximal femur (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.