OsteoporosisNCT00848159
Postural Assessment by Photogrammetry
An observational study of Osteoporosis, run by Universidade de Franca.
Trial summary
This study aimed to measure the degree of thoracic kyphosis in elderly women with those affected by osteoporosis in the spine, through photogrammetry computer and check the difference between the values obtained with the assumption of greater thoracic kyphosis in osteoporotic women. Read more about this study
- Who is it for?
- Ages 65 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Feb 2009
- 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 65 to 74 years
- Women only
- Healthy volunteers accepted
- Older adult
Study population: The investigators evaluated 12 women with mean age of 68.5 years (range 65 to 74 years), divided into two groups. Group 1 consists of six women with a densitometric diagnosis of osteoporosis in column (SD: -2.70 to -4.97) and group 2 consists of six women with a densitometric diagnosis of osteopenia in column (DP: 1.07 to -2 , 09), both compared with young adults.
Who may be able to join
- age between 50 and 80 years
- with examination of bone densitometry
- with densitometric diagnosis of osteopenia in the first group, the second group for osteoporosis,
- willing to participate in the study
Who cannot join
- presence of severe scoliosis, ankylosing spondylitis, obesity
- presence of neurological diseases serious
About this study
Official title: Evaluation of Thoracic Kyphosis in Elderly Women Affected by Osteoporosis Through Computerized Photogrammetry
This study aimed to measure the degree of thoracic kyphosis in elderly women with those affected by osteoporosis in the spine, through photogrammetry computer and check the difference between the values obtained with the assumption of greater thoracic kyphosis in osteoporotic women.
Read the detailed description
The decrease in bone density of vertebrae leads to a reduction of the anterior vertebral bodies, resulting in compression and collapse of vertebrae, with narrowing of intervertebral disc spaces and, determining a number of deformities in the spine and postural changes, among which can highlight the increase in thoracic kyphosis. This becomes significantly higher with age and after menopause, defined as an increase in curvature in the sagittal plane of the thoracic spine.
Radiographic images have been used for the measurement of thoracic kyphosis, but with some drawbacks of this method such as radiation exposure, radiographic image quality unsatisfactory hampering its analysis and the lack of equipment in the physical environment to monitor clinical evolution of the treatment, causing thus the search for noninvasive methods for evaluating the curves of the spine, including the photogrammetry computed.
According to the American Society of Photogrammetry, the computed photogrammetry is "the art, science and technology of information on physical objects and environment through processes of recording, measuring and interpreting photographic images and patterns of electromagnetic radiant energy and other sources." It is a widely used tool for assessment by quantifying the postural changes through the application of photogrammetric principles to photographic images obtained in body movements, adding to the diagnostic evaluation for physical therapy in different areas.
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, kyphosis, photogrammetry
- Medical subject headings
- Osteoporosis, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group 1 was composed of six women with a densitometric diagnosis of osteoporosis in column (DP =- 2.70 to -4.97), with an average weight of 57.5 (+6.9) kg, mean height of 1 , 4 (+ 0.07) my body mass index (BMI) of 26.1 (+1.8) Kg/m2 | |
| 2 | Group 2 consists of six women with a densitometric diagnosis of osteopenia in column (DP =- 1.07 to -2.09), with an average weight of 62.1 (+9.9) kg, mean height of 1, 5 (+0.03) I BMI 25.3 (3.3) kg/m2, both compared with young adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Photogrammetry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startApr 2007
- Primary completionNov 2007
- Study completionFeb 2009
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
- Observational
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Universidade de Franca
- Sponsor type
- University, hospital or other
- Investigators
- Ana Cristina Rodrigues, Principal investigator, Universidade de FrancaLislei Patrizzi, Principal investigator, Universidade de Franca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848159
- Sponsor's protocol ID
- 041/07
- Status last verified
- Feb 2009
- First submitted
- 19 Feb 2009
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thoracic Kyphosis in Elderly Women Affected by Osteoporosis Through Computerized Photogrammetry
- ClinicalTrials.gov ID
- NCT00848159
- Acronym / sponsor ID
- 041/07
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, kyphosis, photogrammetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Universidade de FrancaUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 20 Feb 2009 (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 study aimed to measure the degree of thoracic kyphosis in elderly women with those affected by osteoporosis in the spine, through photogrammetry computer and check the difference between the values obtained with the assumption of greater thoracic kyphosis in osteoporotic women.
Detailed description
The decrease in bone density of vertebrae leads to a reduction of the anterior vertebral bodies, resulting in compression and collapse of vertebrae, with narrowing of intervertebral disc spaces and, determining a number of deformities in the spine and postural changes, among which can highlight the increase in thoracic kyphosis. This becomes significantly higher with age and after menopause, defined as an increase in curvature in the sagittal plane of the thoracic spine.
Radiographic images have been used for the measurement of thoracic kyphosis, but with some drawbacks of this method such as radiation exposure, radiographic image quality unsatisfactory hampering its analysis and the lack of equipment in the physical environment to monitor clinical evolution of the treatment, causing thus the search for noninvasive methods for evaluating the curves of the spine, including the photogrammetry computed.
According to the American Society of Photogrammetry, the computed photogrammetry is "the art, science and technology of information on physical objects and environment through processes of recording, measuring and interpreting photographic images and patterns of electromagnetic radiant energy and other sources." It is a widely used tool for assessment by quantifying the postural changes through the application of photogrammetric principles to photographic images obtained in body movements, adding to the diagnostic evaluation for physical therapy in different areas.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Group 1 was composed of six women with a densitometric diagnosis of osteoporosis in column (DP =- 2.70 to -4.97), with an average weight of 57.5 (+6.9) kg, mean height of 1 , 4 (+ 0.07) my body mass index (BMI) of 26.1 (+1.8) Kg/m2 |
| 2 | – | –Group 2 consists of six women with a densitometric diagnosis of osteopenia in column (DP =- 1.07 to -2.09), with an average weight of 62.1 (+9.9) kg, mean height of 1, 5 (+0.03) I BMI 25.3 (3.3) kg/m2, both compared with young adults |
Who may qualify
- Ages
- 65 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The investigators evaluated 12 women with mean age of 68.5 years (range 65 to 74 years), divided into two groups. Group 1 consists of six women with a densitometric diagnosis of osteoporosis in column (SD: -2.70 to -4.97) and group 2 consists of six women with a densitometric diagnosis of osteopenia in column (DP: 1.07 to -2 , 09), both compared with young adults.
Key inclusion criteria (4 listed)
- age between 50 and 80 years
- with examination of bone densitometry
- with densitometric diagnosis of osteopenia in the first group, the second group for osteoporosis,
- willing to participate in the study
Key exclusion criteria (2 listed)
- presence of severe scoliosis, ankylosing spondylitis, obesity
- presence of neurological diseases serious
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
Computerized Photogrammetry
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 20 Feb 2009.
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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.
Ana Cristina Rodrigues principal investigator
Universidade de Franca
Lislei Patrizzi principal investigator
Universidade de Franca
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Universidade de Franca.
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 2 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 20 Feb 2009. 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 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?
Computerized Photogrammetry. 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 20 Feb 2009.