Osteoporosis FractureNCT03798444
Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women
An observational study of Osteoporosis Fracture, run by Central South University at 1 site in China.
Trial summary
This is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in Chinese postmenopausal women 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 Fracture
- What is being tested?
- dual energy X-ray absorptiometry and lateral spine imaging from T4 to L4 on X-ray
- Type of treatment
- Surgery or procedure
- How many people
- 255 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Sep 2017
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017.
Who may be able to join
- Postmenopausal women aged ≥50 years (Menopause was defined as the absence of menstrual cycles for at least one year)
Who cannot join
- Morphological abnormalities or skeletal distortions
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Xiangya Hospital, Central South University
Changsha, Hunan, 410011
About this study
Official title: An Observational and Cross-sectional Study on Prevalence of Vertebral Fractures in Postmenopausal Women Living in Chinese Communities
This is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in Chinese postmenopausal women
Read the detailed description
Postmenopausal women (N=255) aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs All participants were interviewed using a standard questionnaire. Body weight and height were measured to the closest 0.1 kg and 0.5 cm, respectively, with subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. All subjects provided basic information, including current age, age at the start of menopause, years since menopause (YSM), weight, and their tallest recalled height. The current measured height subtracted from the tallest recalled height was subjects' HHL.The RPD, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. For the kyphosis assessment, subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance (C7WD) , and wall-tragus-distance (WTD) was defined as the horizontal distance from the participant's tragus to the wall . All RPD and anthropometric indicators of kyphosis were measured in increments of 0.1 cm by two trained physicians.BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. VFs were assessed using lateral spine imaging from T4 to L4 on X-ray.
- Conditions
- Osteoporosis Fracture
- Being tested
- dual energy X-ray absorptiometry, lateral spine imaging from T4 to L4 on X-ray
- Keywords
- Height loss, Kyphosis, Osteoporosis, Vertebral fracture, Postmenopausal women
- Medical subject headings
- Osteoporotic Fractures, Kyphosis, Osteoporosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual energy X-ray absorptiometryRadiation
BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. The lumbar spine, left femoral neck, or total hip of T-score ≤-2.5 as the osteoporosis
lateral spine imaging from T4 to L4 on X-rayRadiation
VFs were assessed using lateral spine imaging from T4 to L4 on X-ray .A visual semi-quantitative method was used, with fractures defined as a vertebral Vertebral fractures should be diagnose if height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra
| Study group | Role | What they receive |
|---|---|---|
| Bone mineral denstiy | BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry in all subjects.Accroding to The World Health Organization, we defined osteoporosis as a T-score ≤-2.5,and the non osteoporosis as T-score>-2.5. Receives: Radiation: dual energy X-ray absorptiometry | |
| Vertebral fractures | VFs were assessed using lateral spine imaging from T4 to L4 on X-ray. A visual semi-quantitative method was used, with fractures defined as a vertebral height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra. Receives: Radiation: lateral spine imaging from T4 to L4 on X-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. Height were measured to the closest 0.5 cm,
Measured: 4 weeks
Weight
Body weight was measured with subjects wearing light clothing and no shoes
Measured: 4 weeks
Rib to pelvis distance
The rib to pelvis distance, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. Measured in increments of 0.1 cm by two trained physicians.
Measured: 4 weeks
Wall-occiput distance
Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. Measured in increments of 0.1 cm by two trained physicians.
Measured: 4 weeks
7th cervical vertebra-wall distance
Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance. Measured in increments of 0.1 cm by two trained physicians.
Measured: 4 weeks
Wall-tragus-distance
Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown.Wall-tragus-distance was defined as the horizontal distance from the participant's tragus to the wall. Measured in increments of 0.1 cm by two trained physicians.
Measured: 4 weeks
Historical height loss
The current measured height subtracted from the tallest recalled height was subjects' historical height loss
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Sep 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis FractureStudies 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenRong, Central South University
- Investigators
- sheng zhifeng, MD, Principal investigator, Central south of university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798444
- Sponsor's protocol ID
- CRong
- Status last verified
- Jan 2019
- First submitted
- 20 Nov 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yoh K, Kuwabara A, Tanaka K. Detective value of historical height loss and current height/knee height ratio for prevalent vertebral fracture in Japanese postmenopausal women. J Bone Miner Metab. 2014 Sep;32(5):533-8. doi: 10.1007/s00774-013-0525-y.
PubMed 24122280Siminoski K, Warshawski RS, Jen H, Lee K. The accuracy of historical height loss for the detection of vertebral fractures in postmenopausal women. Osteoporos Int. 2006 Feb;17(2):290-6. doi: 10.1007/s00198-005-2017-y. Epub 2005 Sep 6.
PubMed 16143833Siminoski K, Warshawski RS, Jen H, Lee KC. Accuracy of physical examination using the rib-pelvis distance for detection of lumbar vertebral fractures. Am J Med. 2003 Aug 15;115(3):233-6. doi: 10.1016/s0002-9343(03)00299-7. No abstract available.
PubMed 12935830Mizukami S, Abe Y, Tsujimoto R, Arima K, Kanagae M, Chiba G, Aoyagi K. Accuracy of spinal curvature assessed by a computer-assisted device and anthropometric indicators in discriminating vertebral fractures among individuals with back pain. Osteoporos Int. 2014 Jun;25(6):1727-34. doi: 10.1007/s00198-014-2680-y. Epub 2014 Mar 14.
PubMed 24627138Suwannarat P, Amatachaya P, Sooknuan T, Tochaeng P, Kramkrathok K, Thaweewannakij T, Manimmanakorn N, Amatachaya S. Hyperkyphotic measures using distance from the wall: validity, reliability, and distance from the wall to indicate the risk for thoracic hyperkyphosis and vertebral fracture. Arch Osteoporos. 2018 Mar 12;13(1):25. doi: 10.1007/s11657-018-0433-9.
PubMed 29532182Ralston SH, Urquhart GD, Brzeski M, Sturrock RD. Prevalence of vertebral compression fractures due to osteoporosis in ankylosing spondylitis. BMJ. 1990 Mar 3;300(6724):563-5. doi: 10.1136/bmj.300.6724.563.
PubMed 2108749
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational and Cross-sectional Study on Prevalence of Vertebral Fractures in Postmenopausal Women Living in Chinese Communities
- ClinicalTrials.gov ID
- NCT03798444
- Acronym / sponsor ID
- CRong
- Conditions
- Osteoporosis Fracture
- Keywords
- Height loss, Kyphosis, Osteoporosis, Vertebral fracture, Postmenopausal women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 10 Jan 2019 (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.
This is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in Chinese postmenopausal women
Detailed description
Postmenopausal women (N=255) aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017. Menopause was defined as the absence of menstrual cycles for at least one year. All subjects were noninstitutionalized and in good health.The criteria for exclusion were morphological abnormalities or skeletal distortions that prohibited either clinical measurements or morphometric assessments of skeletal radiographs All participants were interviewed using a standard questionnaire. Body weight and height were measured to the closest 0.1 kg and 0.5 cm, respectively, with subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. All subjects provided basic information, including current age, age at the start of menopause, years since menopause (YSM), weight, and their tallest recalled height. The current measured height subtracted from the tallest recalled height was subjects' HHL.The RPD, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. For the kyphosis assessment, subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance (C7WD) , and wall-tragus-distance (WTD) was defined as the horizontal distance from the participant's tragus to the wall . All RPD and anthropometric indicators of kyphosis were measured in increments of 0.1 cm by two trained physicians.BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. VFs were assessed using lateral spine imaging from T4 to L4 on X-ray.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone mineral denstiy | – | Radiation: dual energy X-ray absorptiometryBMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry in all subjects.Accroding to The World Health Organization, we defined osteoporosis as a T-score ≤-2.5,and the non osteoporosis as T-score>-2.5. |
| Vertebral fractures | – | Radiation: lateral spine imaging from T4 to L4 on X-rayVFs were assessed using lateral spine imaging from T4 to L4 on X-ray. A visual semi-quantitative method was used, with fractures defined as a vertebral height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017.
Key inclusion criteria (1 listed)
- Postmenopausal women aged ≥50 years (Menopause was defined as the absence of menstrual cycles for at least one year)
Key exclusion criteria (1 listed)
- Morphological abnormalities or skeletal distortions
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 |
|---|---|---|
| dual energy X-ray absorptiometryBMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. The lumbar spine, left femoral neck, or total hip of T-score ≤-2.5 as the osteoporosis | Radiation | Bone mineral denstiy |
| lateral spine imaging from T4 to L4 on X-rayVFs were assessed using lateral spine imaging from T4 to L4 on X-ray .A visual semi-quantitative method was used, with fractures defined as a vertebral Vertebral fractures should be diagnose if height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra | Radiation | Vertebral fractures |
Primary outcome
Height
Time frame: 4 weeks
Subjects wearing light clothing and no shoes. Current height was measured using a wall-mounted stadiometer, with a horizontal plate pressed on the head, and hair flattened. Height were measured to the closest 0.5 cm,
Weight
Time frame: 4 weeks
Body weight was measured with subjects wearing light clothing and no shoes
Rib to pelvis distance
Time frame: 4 weeks
The rib to pelvis distance, which was the vertical distance between the lowest margin of the ribs and the superior surface of the iliac crest along the mid-axillary line, was measured twice by a physician who stood behind the subject. Measured in increments of 0.1 cm by two trained physicians.
Wall-occiput distance
Time frame: 4 weeks
Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The wall-occiput distance was defined as the horizontal distance between the wall and the back of the head. Measured in increments of 0.1 cm by two trained physicians.
7th cervical vertebra-wall distance
Time frame: 4 weeks
Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown. The distance between the prominence of the 7th cervical vertebra and the wall was defined as 7th cervical vertebra-wall distance. Measured in increments of 0.1 cm by two trained physicians.
Wall-tragus-distance
Time frame: 4 weeks
Subjects were measured without shoes, with their heels, buttocks, and back to the wall, and head in a horizontal position with a double chin shown.Wall-tragus-distance was defined as the horizontal distance from the participant's tragus to the wall. Measured in increments of 0.1 cm by two trained physicians.
Historical height loss
Time frame: 4 weeks
The current measured height subtracted from the tallest recalled height was subjects' historical height loss
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 10 Jan 2019.
- Background: PubMed 24122280Yoh K, Kuwabara A, Tanaka K. Detective value of historical height loss and current height/knee height ratio for prevalent vertebral fracture in Japanese postmenopausal women. J Bone Miner Metab. 2014 Sep;32(5):533-8. doi: 10.1007/s00774-013-0525-y.
- Background: PubMed 16143833Siminoski K, Warshawski RS, Jen H, Lee K. The accuracy of historical height loss for the detection of vertebral fractures in postmenopausal women. Osteoporos Int. 2006 Feb;17(2):290-6. doi: 10.1007/s00198-005-2017-y. Epub 2005 Sep 6.
- Background: PubMed 12935830Siminoski K, Warshawski RS, Jen H, Lee KC. Accuracy of physical examination using the rib-pelvis distance for detection of lumbar vertebral fractures. Am J Med. 2003 Aug 15;115(3):233-6. doi: 10.1016/s0002-9343(03)00299-7. No abstract available.
- Background: PubMed 24627138Mizukami S, Abe Y, Tsujimoto R, Arima K, Kanagae M, Chiba G, Aoyagi K. Accuracy of spinal curvature assessed by a computer-assisted device and anthropometric indicators in discriminating vertebral fractures among individuals with back pain. Osteoporos Int. 2014 Jun;25(6):1727-34. doi: 10.1007/s00198-014-2680-y. Epub 2014 Mar 14.
- Background: PubMed 29532182Suwannarat P, Amatachaya P, Sooknuan T, Tochaeng P, Kramkrathok K, Thaweewannakij T, Manimmanakorn N, Amatachaya S. Hyperkyphotic measures using distance from the wall: validity, reliability, and distance from the wall to indicate the risk for thoracic hyperkyphosis and vertebral fracture. Arch Osteoporos. 2018 Mar 12;13(1):25. doi: 10.1007/s11657-018-0433-9.
- Background: PubMed 2108749Ralston SH, Urquhart GD, Brzeski M, Sturrock RD. Prevalence of vertebral compression fractures due to osteoporosis in ankylosing spondylitis. BMJ. 1990 Mar 3;300(6724):563-5. doi: 10.1136/bmj.300.6724.563.
- Individual participant dataSharing planned: Undecided
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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.
sheng zhifeng, MD principal investigator
Central south of university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis Fracture, run by Central South University at 1 site in China.
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 1 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 10 Jan 2019. 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 China. 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?
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?
Height (time frame: 4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798444, which also lists 6 linked publications.
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 10 Jan 2019.