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

NCT03798444 | Completed

• 1 other identifier: CRong
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoporosis Fracture

Keywords

Height loss, Kyphosis; Osteoporosis, Vertebral fracture; Postmenopausal women

Outcome Measures

Primary Outcomes (7)

• 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

• Weight

  Body weight was measured with subjects wearing light clothing and no shoes

  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.

  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.

  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.

  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.

  4 weeks

• Historical height loss

  The current measured height subtracted from the tallest recalled height was subjects' historical height loss

  4 weeks

Study Arms (2)

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.

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.

Radiation: lateral spine imaging from T4 to L4 on X-ray

Interventions

dual energy X-ray absorptiometry 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

Bone mineral denstiy

lateral spine imaging from T4 to L4 on X-ray 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

Vertebral fractures

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Postmenopausal women aged ≥50 years (Menopause was defined as the absence of menstrual cycles for at least one year)

You may not qualify if:

• Morphological abnormalities or skeletal distortions

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The 2nd Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

Related Publications (6)

• 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.

  PMID: 24122280 BACKGROUND

• 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.

  PMID: 16143833 BACKGROUND

• 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.

  PMID: 12935830 BACKGROUND

• 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.

  PMID: 24627138 BACKGROUND

• 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.

  PMID: 29532182 BACKGROUND

• 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.

  PMID: 2108749 BACKGROUND

MeSH Terms

Conditions

Osteoporotic Fractures; Kyphosis; Osteoporosis; Spinal Fractures

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Metabolic; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• sheng zhifeng, MD

  Central south of university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: January 10, 2019
• Study Start: September 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

CN (1)