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

Osteoporosis Fracture Clinical Trial

Official title:

An Observational and Cross-sectional Study on Prevalence of Vertebral Fractures in Postmenopausal Women Living in Chinese Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798444
• Other study ID #: CRong
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: January 2019
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Osteoporosis
• Osteoporosis Fracture
• Osteoporotic Fractures
• Spinal Fractures

Intervention

Radiation:
• 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
• 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

Locations

Country	Name	City	State
China	The 2nd Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. Epub 2005 Sep 6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,	4 weeks
Primary	Weight	Body weight was measured with subjects wearing light clothing and no shoes	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	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.	4 weeks
Primary	Historical height loss	The current measured height subtracted from the tallest recalled height was subjects' historical height loss	4 weeks