OsteoporosisNCT04768712
Effect of Physical Activity in Women With Manifest Osteporosis
A study testing Weight bearing aerobic exercise in people with Osteoporosis, run by Sahlgrenska University Hospital.
Trial summary
Objectives: To investigate if a physical activity intervention (one year) can reduce the risk of falls (primary endpoint), improve physical function (balance and muscle strength) and cortical bone geometry as well as trabecular microarchitecture (secondary endpoints) in women, 70-80 years old, with manifest… Read more about this study
- Who is it for?
- Ages 70 to 80 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Weight bearing aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2012to 10 Jun 2012
- 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 70 to 80 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 70-80 years of age
- manifest osteoporosis, BMD T-score ≤2.5 SD at the lumbar spine and/or hip
- female
- walk without walking aid
Who cannot join
- male
- high level of exercise, ≥2 times/week, at baseline
- secondary osteoporosis
- previous treatment with bisphosphonate or other osteoporosis induced medicine
About this study
Official title: The Effect of Physical Activity on Physical Function, Falls and Bone Geometry - a Randomized Control Trial in Women With Manifest Osteoporosis
Objectives: To investigate if a physical activity intervention (one year) can reduce the risk of falls (primary endpoint), improve physical function (balance and muscle strength) and cortical bone geometry as well as trabecular microarchitecture (secondary endpoints) in women, 70-80 years old, with manifest osteoporosis, treated with zoledronic acid, calcium and vitamin D.
Strategic goal: To include 200 patients (100 intervention and 100 controls) during 2010 and 2011 and randomize 100 patients to a one year physical activity intervention (3 hours weekly). The results will be published in an international scientific peer-review journal. All patients will receive standard medical treatment with calcium, vitamin D and yearly zoledronic acid.
Read more
Study rationale: The role of physical activity intervention has not previously been evaluated in patients with manifest osteoporosis and zoledronic acid treatment.
Methodology: Randomized controlled trial. All included patients (women 70-80 years of age) will have manifest osteoporosis, be treatment naïve, and will be treated on clinical indication with yearly infusions of zoledronic acid (approved treatment, for this patient category, by the Swedish Medical Products Agency). Patients with secondary osteoporosis, with disabilities, and with high levels of exercise at the baseline visit will be excluded. Intention to treat analysis will be used. Physical activity intervention includes 3 hours of weight bearing aerobic exercise per week, using a standardized program. Patients in both groups will be contacted monthly and asked about their exercise habits. Frequency of falls, physical activity level will be ascertained using questionnaires. Balance and muscle strength will be assessed using standardized tests. Bone geometry at the tibia diaphysis will be determined using an XCT2000 pQCT device (Stratec, Germany) and trabecular microarchitecture at the tibia metaphysis will be determined using an XtremeCT device (Scanco Medical AG, Switzerland). These examinations will be performed on all patients prior to the intervention and after the completion of the study.
- Conditions
- Osteoporosis
- Being tested
- Weight bearing aerobic exercise
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight bearing aerobic exerciseBehavioural
Weight bearing aerobic exercise three times per week.
| Study group | Role | What they receive |
|---|---|---|
| Weight bearing aerobic exercise | Experimental | Not described Receives: Behavioral: Weight bearing aerobic exercise |
| Lifestyle counseling | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propensity to fall
Frequency of falls during time of intervention.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Physical function (Balance and muscle strength)
Measured: Prior to the intervention and after the completion (an average of 1 year) of the study
Trabecular microarchitecture
Measured: Prior to the intervention and after the completion (an average of 1 year) of the study
Cortical bone geometry
Measured: Prior to the intervention and after the completion (an average of 1 year) of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start10 Jun 2012 (estimated)
- Primary completion10 Jun 2012 (estimated)
- Study completion10 Jun 2012
Why it stopped: Lack of funding
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 Sahlgrenska University HospitalThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattias Lorentzon, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768712
- Sponsor's protocol ID
- VGFOUREG-81091
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity on Physical Function, Falls and Bone Geometry - a Randomized Control Trial in Women With Manifest Osteoporosis
- ClinicalTrials.gov ID
- NCT04768712
- Acronym / sponsor ID
- VGFOUREG-81091
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 10 Jun 2012 (estimated)
- Primary completion
- 10 Jun 2012 (estimated)
- Study completion
- 10 Jun 2012 (actual)
- First posted
- 24 Feb 2021 (actual)
- 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.
Objectives: To investigate if a physical activity intervention (one year) can reduce the risk of falls (primary endpoint), improve physical function (balance and muscle strength) and cortical bone geometry as well as trabecular microarchitecture (secondary endpoints) in women, 70-80 years old, with manifest osteoporosis, treated with zoledronic acid, calcium and vitamin D.
Strategic goal: To include 200 patients (100 intervention and 100 controls) during 2010 and 2011 and randomize 100 patients to a one year physical activity intervention (3 hours weekly). The results will be published in an international scientific peer-review journal. All patients will receive standard medical treatment with calcium, vitamin D and yearly zoledronic acid.
Study rationale: The role of physical activity intervention has not previously been evaluated in patients with manifest osteoporosis and zoledronic acid treatment.
Methodology: Randomized controlled trial. All included patients (women 70-80 years of age) will have manifest osteoporosis, be treatment naïve, and will be treated on clinical indication with yearly infusions of zoledronic acid (approved treatment, for this patient category, by the Swedish Medical Products Agency). Patients with secondary osteoporosis, with disabilities, and with high levels of exercise at the baseline visit will be excluded. Intention to treat analysis will be used. Physical activity intervention includes 3 hours of weight bearing aerobic exercise per week, using a standardized program. Patients in both groups will be contacted monthly and asked about their exercise habits. Frequency of falls, physical activity level will be ascertained using questionnaires. Balance and muscle strength will be assessed using standardized tests. Bone geometry at the tibia diaphysis will be determined using an XCT2000 pQCT device (Stratec, Germany) and trabecular microarchitecture at the tibia metaphysis will be determined using an XtremeCT device (Scanco Medical AG, Switzerland). These examinations will be performed on all patients prior to the intervention and after the completion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight bearing aerobic exercise | Experimental | Behavioral: Weight bearing aerobic exercise |
| Lifestyle counseling | No intervention | – |
Who may qualify
- Ages
- 70 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 70-80 years of age
- manifest osteoporosis, BMD T-score ≤2.5 SD at the lumbar spine and/or hip
- female
- walk without walking aid
Key exclusion criteria (4 listed)
- male
- high level of exercise, ≥2 times/week, at baseline
- secondary osteoporosis
- previous treatment with bisphosphonate or other osteoporosis induced medicine
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 |
|---|---|---|
| Weight bearing aerobic exerciseWeight bearing aerobic exercise three times per week. | Behavioural | Weight bearing aerobic exercise |
Primary outcome
Propensity to fall
Time frame: Through study completion, an average of 1 year
Frequency of falls during time of intervention.
3 secondary outcomes
Physical function (Balance and muscle strength)
Time frame: Prior to the intervention and after the completion (an average of 1 year) of the study
Trabecular microarchitecture
Time frame: Prior to the intervention and after the completion (an average of 1 year) of the study
Cortical bone geometry
Time frame: Prior to the intervention and after the completion (an average of 1 year) of the study
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 24 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Weight bearing aerobic exercise in people with Osteoporosis, run by Sahlgrenska University Hospital.
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 4 inclusion and 4 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 24 Feb 2021. 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?
Propensity to fall (time frame: Through study completion, an average of 1 year). 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 24 Feb 2021.