Osteoporosis, OsteopeniaNCT01844154
Fracture and Fall Prevention in Elderly With Osteoporosis
An observational study of Osteoporosis, Osteopenia, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Osteopenia
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- Oct 2012to Dec 2016
- Phase
- Observational
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: osteopenia (-2.5 < t-score < -1.0) or osteoporosis (t-score <-2.5)
Who may be able to join
- able to stand and walk for 5 minutes independently
- having normal or corrected to normal vision
- having age between > 50 years
- already have DEXA and X-ray exam with osteopenia (-2.5 < t-score < -1.0) or osteoporosis (t-score <-2.5)
- able to stand and walk for 5 minutes independently
- having normal or corrected to normal vision
- having age between > 50 years
- already have DEXA and X-ray exam without osteopenia or osteoporosis (t-score > -1.0)
Who cannot join
- being pregnant
- sensory-motor deficits
- inability of communication
- lack of access to a telephone
- t-score <-2.5 combine with existing fracture
- control age-matched group:
Show all 11Show fewer
- being pregnant
- sensory-motor deficits
- inability of communication
- lack of access to a telephone
- t-score <-2.5 combine with existing fracture
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University
Taipei, Taiwan, 100
Wei-Li Hsu, PhD, wlhsu@ntu.edu.tw
- Not yet recruiting
School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei
Wei-Li Hsu, PT,PhD, 886-2-3366-8127, wlhsu@ntu.edu.tw
About this study
Official title: Fracture and Fall Prevention in Elderly With Osteoporosis: Long-term Follow up
Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.
- Conditions
- Osteoporosis, Osteopenia
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activation during balance recovery
Data collection will be carried out in 2 sessions in 2 different days within the span of a week. The first day of data collection includes basic information, anthropometric measure, clinical tests, and functional tests. The second day of data collection includes muscle and joint assessment, and biomechanical tests. Each session last approximately 2.5 hours in duration.
Measured: every 3 month, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, OsteopeniaStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Hsu, PT,PhD, Principal investigator, School of physical therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844154
- Sponsor's protocol ID
- 201204059RIC
- Status last verified
- Mar 2016
- First submitted
- 5 Oct 2012
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fracture and Fall Prevention in Elderly With Osteoporosis: Long-term Follow up
- ClinicalTrials.gov ID
- NCT01844154
- Acronym / sponsor ID
- 201204059RIC
- Conditions
- Osteoporosis, Osteopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 May 2013 (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.
Osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury or mortality. Identifying the factors related to falls occurring within this population is essential for the development of effective regimes for fall prevention. Studies have shown that muscle quality and good posture alignments are critical for balance control in older adults. People are diagnosed with osteoporosis often combining with muscles weakness, and increased spine kyphosis leading vertebral, fractures and poor balance control, even falls. Therefore, improving muscle quality, strengthening weak muscles and correcting postural alignment are essential elements for fracture and fall prevention in older adults with osteoporosis. The long-term objectives of this work are to prevent fracture and fall in older adults with osteoporosis by improving the function of degenerative muscles using exercise training.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- osteopenia (-2.5 < t-score < -1.0) or osteoporosis (t-score <-2.5)
Key inclusion criteria (8 listed)
- able to stand and walk for 5 minutes independently
- having normal or corrected to normal vision
- having age between > 50 years
- already have DEXA and X-ray exam with osteopenia (-2.5 < t-score < -1.0) or osteoporosis (t-score <-2.5)
- able to stand and walk for 5 minutes independently
Key exclusion criteria (11 listed)
- being pregnant
- sensory-motor deficits
- inability of communication
- lack of access to a telephone
- t-score <-2.5 combine with existing fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle activation during balance recovery
Time frame: every 3 month, up to 1 year
Data collection will be carried out in 2 sessions in 2 different days within the span of a week. The first day of data collection includes basic information, anthropometric measure, clinical tests, and functional tests. The second day of data collection includes muscle and joint assessment, and biomechanical tests. Each session last approximately 2.5 hours in duration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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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.
Wei-Li Hsu, PT,PhD principal investigator
School of physical therapy, National Taiwan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Osteopenia, run by National Taiwan University Hospital at 2 sites in Taiwan.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Li Hsu, PT,PhD (886-2-33668127, wlhsu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activation during balance recovery (time frame: every 3 month, up to 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 3 Mar 2016.