Height Loss, Kyphosis Indicators, Bone Mineral Density and Vertebral Fractures in Chinese Postmenopausal Women

NCT ID: NCT03798444

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 255 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2017-09-30

Brief 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

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

dual energy X-ray absorptiometry

Intervention Type: RADIATION

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.

lateral spine imaging from T4 to L4 on X-ray

Intervention Type: RADIATION

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

Interventions

dual energy X-ray absorptiometry

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

Intervention Type: RADIATION

lateral spine imaging from T4 to L4 on X-ray

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

ChenRong

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sheng zhifeng, MD

Role: PRINCIPAL_INVESTIGATOR

Central south of university

Locations

The 2nd Xiangya Hospital, Central South University

Changsha, Hunan, China

Countries

China

References

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Reference Type: BACKGROUND

PMID: 24122280 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16143833 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 24627138 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29532182 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2108749 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CRong

Identifier Type: -

Identifier Source: org_study_id