- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03798444
Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women
January 7, 2019 updated by: ChenRong, Central South University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
255
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hunan
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Changsha, Hunan, China, 410011
- The 2nd Xiangya Hospital, Central South University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
48 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Postmenopausal women aged ≥50 years were randomly selected from community centers in Changsha City, Hunan Province, China in September 2017.
Description
Inclusion Criteria:
Postmenopausal women aged ≥50 years (Menopause was defined as the absence of menstrual cycles for at least one year)
Exclusion Criteria:
Morphological abnormalities or skeletal distortions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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,
|
4 weeks
|
Weight
Time Frame: 4 weeks
|
Body weight was measured with subjects wearing light clothing and no shoes
|
4 weeks
|
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.
|
4 weeks
|
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.
|
4 weeks
|
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.
|
4 weeks
|
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.
|
4 weeks
|
Historical height loss
Time Frame: 4 weeks
|
The current measured height subtracted from the tallest recalled height was subjects' historical height loss
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: sheng zhifeng, MD, Central south of university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Siminoski 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.
- Siminoski 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.
- Mizukami 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.
- Suwannarat 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.
- Ralston 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
September 30, 2017
Study Completion (Actual)
September 30, 2017
Study Registration Dates
First Submitted
November 20, 2018
First Submitted That Met QC Criteria
January 7, 2019
First Posted (Actual)
January 10, 2019
Study Record Updates
Last Update Posted (Actual)
January 10, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRong
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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