Osteoporosis Fracture Clinical Trial
Official title:
An Observational and Cross-sectional Study on Prevalence of Vertebral Fractures in Postmenopausal Women Living in Chinese Communities
NCT number | NCT03798444 |
Other study ID # | CRong |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2017 |
Est. completion date | September 30, 2017 |
Verified date | January 2019 |
Source | Central South University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an observational and cross-sectional study on the height loss, kyphosis indicators, bone mineral density and vertebral fractures in Chinese postmenopausal women
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 |
Country | Name | City | State |
---|---|---|---|
China | The 2nd Xiangya Hospital, Central South University | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Central South University |
China,
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
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 |
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