OsteoporosisNCT00431002
Provincial Roll-Out Bone Health Strategy
A study testing Resistance training in people with Osteoporosis, run by University of British Columbia.
Trial summary
The main purpose of this study is to investigate the effect of two different group-based exercise programs on fall risk (muscular strength and balance) and bone strength in older women aged over 65-75 years who have low bone mass. Read more about this study
- Who is it for?
- Ages 65 to 75 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2008
- Phase
- Interventional
- 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 65 to 75 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- inactive (less than twice weekly exercising) women aged 65-75 years old
Who cannot join
None listed.
About this study
The main purpose of this study is to investigate the effect of two different group-based exercise programs on fall risk (muscular strength and balance) and bone strength in older women aged over 65-75 years who have low bone mass. We are also trying to determine if once a week exercise is as effective on health outcomes as twice a week. We hypothesize that twice a week exercise will be more effective than once a week or sham exercise.
- Conditions
- Osteoporosis
- Being tested
- Resistance training
- Keywords
- Exercise, Resistance training
- Medical subject headings
- Osteoporosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
See Detailed Description.
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic Profile Assessment (Fall Risk)
Secondary outcomes (1)
Bone strength using peripheral quantitative computed tomography (pQCT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study completionSep 2008
Why it stopped: Withdrawn
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maureen C. Ashe, University of British Columbia
- Investigators
- K M Khan, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431002
- Sponsor's protocol ID
- H05-70624
- Status last verified
- May 2017
- First submitted
- 31 Jan 2007
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provincial Roll-Out Bone Health Strategy
- ClinicalTrials.gov ID
- NCT00431002
- Acronym / sponsor ID
- H05-70624
- Conditions
- Osteoporosis
- Keywords
- Exercise, Resistance training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study completion
- Sep 2008
- First posted
- 2 Feb 2007 (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.
The main purpose of this study is to investigate the effect of two different group-based exercise programs on fall risk (muscular strength and balance) and bone strength in older women aged over 65-75 years who have low bone mass. We are also trying to determine if once a week exercise is as effective on health outcomes as twice a week. We hypothesize that twice a week exercise will be more effective than once a week or sham exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- inactive (less than twice weekly exercising) women aged 65-75 years old
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Resistance trainingSee Detailed Description. | Behavioural | – |
Primary outcome
Physiologic Profile Assessment (Fall Risk)
1 secondary outcome
Bone strength using peripheral quantitative computed tomography (pQCT)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
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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.
K M Khan, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Osteoporosis, run by University of British Columbia.
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 1 inclusion and 0 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: withdrawn, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Physiologic Profile Assessment (Fall Risk). 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 16 May 2017.