Protocol - Spine and Femur Bone Density by Dual-Energy X-ray Absorptiometry
- Arthritis/Osteoarthritis
- Body Composition - Body Composition by Dual-Energy X-Ray Absorptiometry
- Body Composition - Subscapular Skinfold Thickness
- Body Composition - Suprailiac Skinfold Thickness
- Fracture History
Description
The Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam includes instructions for preparing the sample person for the scan, performing quality assurance procedures, and performing the scan of the hip and spine.
Specific Instructions
Given that there are multiple manufacturers and models of dual-energy X-ray absorptiometry (DXA) machines (each with associated software), investigators must report the equipment they are using and cannot directly compare bone density measurements from different DXA machines (per the International Society for Clinical Densitometry (2007) and Bonnick, S. L. (2009)). Additionally, weekly scans using DXA phantoms are recommended as an independent assessment of system calibration. Studies that use more than one DXA machine should also implement a plan to monitor inter-scanner differences at baseline and at regular intervals during the study. Additionally, for studies involving more than one technician, an average precision error that combines data from all of the technicians should be used to establish the least significant change (LSC) and the precision error for the DXA facility (per the International Society for Clinical Densitometry (2007)). Lastly, the precision error for technicians should be evaluated periodically, such as after they have received training on the specific DXA machine, have completed DXA scans on about 100 patients, if there has been a change in their skill level, or if a new DXA system is used (per the International Society for Clinical Densitometry (2007)).
Note: Manufacturers of DXA equipment are constantly striving to improve and update both their equipment and software with the latest technological advances. Hence, please refer to the DXA specifications for your model number to ensure that the level of information collected is compatible with the PhenX protocol.
Given that the selected protocol uses a GE Lunar densitometer©, the PhenX Skin, Bone, Muscle and Joint Working Group recommends that users of HologicTM densitometers find comparable protocols used by the National Health and Nutrition Examination Survey (NHANES).
DXA measurement is complex and requires costly hardware, specialized software to analyze the DXA scans, rigorous quality control, specialized examiners, continuous equipment calibration and monitoring, and scan quality control monitoring. Although excerpts of the procedure manual for the Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam (May 2008–2010) protocol are provided for informational purposes, investigators should review all facets of the protocol prior to undertaking DXA examinations in a study.
Availability
Protocol
The following is a summary of the Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam (May 2008–2010) manual. These excerpts refer to a specific make and model dual-energy X-ray absorptiometry (DXA) scanner (GE Lunar densitometer©). Several brands of DXA scanners are available and manufacturer-specific software, calibration, and quality control practices should be followed.
A downloadable procedure manual for the Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam (May 2008–2010) is available.
Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam
A. Pre-Clinic Procedures
Dual energy x-ray absorptiometry poses a radiation hazard. Thus, the Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam includes a pre-clinic pregnancy screening questionnaire which is administered to all women younger than 55 years old ten days prior to the visit. Women who are pregnant or trying to get pregnant are excluded from the exam. Women who do not use birth control are asked to abstain from sex 7 days prior to their exam.
B. Daily Quality Assurance and Phantom Procedures
A quality assurance test is performed each day using a black calibration block which consists of tissue-equivalent material and three bone-simulating chambers of known mineral content. Additionally, an encapsulated spine phantom scan is collected every day to standardize on known "vertebral heights."
C. Participants Enter Main Clinic
The lab technician collects urine for a pregnancy test on all women younger than 55 who have not had a tubal ligation or hysterectomy. The technician uses the results of the pregnancy test to complete the Pregnancy Determination form (see Appendix A of the Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam for form). The lab technician also measures/records the participants weight and height if they are not already noted.
D. Participants Enter Bone Room
Consent participant/review pregnancy issues
For men and women who are either aged 55 years or older or have had a tubal ligation or hysterectomy, the bone technician will explain and gather consent for the bone scan. For all other women, the bone technician will review the results of the pregnancy test. If the test is positive, the participant is excluded from the test and is asked to reschedule her scan. If the test is negative, the participant is asked whether she had intercourse in the past week. If the participant indicates the possibility of being pregnant, she is excluded from the test and is asked to reschedule her scan. Once the technician establishes that there is no risk of pregnancy, the technician will explain and gather consent for the bone scan.
Participant preparation
The technician asks the participant to remove any metallic items such as rings, piercings, watches, or hair clips. The technician asks the participant whether he or she has implanted metallic medical devices such as spine implants, hip replacements, pins, and screws. The technician notes the location of any metal items that are not removed before the scan.
E. Hip and AP DXA Scan Procedures
DXA scan acquisition
The technician asks the participant whether he or she has had hip implant/replacement to determine which hip to scan. If both hips have been replaced, the hip scan is not performed. The spine scan is completed regardless of any implants.
Prepare the participant for scan
The participant lies in middle of scanning table. The technician measures the participants waist thickness at the belly button and hip thickness at the inferior iliac spine. The technician records the participants name, ID, birth date, height, weight, gender, and ethnicity and notes any conditions that may affect DXA scan results.
Femur Scan
The technician makes sure that the participant is correctly positioned in the middle of the table and that the participants pelvis is flat and that the spine is straight. The technician then correctly positions the leg and stabilizes it with a foot brace and tissue equivalent bags.
The technician monitors the scan image to make sure that the participant is properly positioned. If the scan is too high or too low, the scan is aborted and started again with a new start position. A correct femur image will show the greater trochanter, the femoral neck, and the ischium.
Spine Scan
The technician removes the foot brace and tissue equivalent bags and positions the participant for the spine scan. The technician uses a support block to elevate the participants legs.
The technician monitors the scan image to make sure that the participant is properly positioned. If the scan is too high or too low, the scan is aborted and started again with a new start position. The technician notes any artifacts seen in the scan. A correct spine image will show the spine in the center, include all of L4, the top of L5 and approximately half of T12.
DXA scan analysis
Femur scan
The technician adjusts the image so that the bone edges can be clearly seen and makes sure that the bone and tissue are correctly identified by the analysis software. The technician ensures the region of interest is correctly positioned as follows:
- The Neck Region of Interest (ROI) does not include any portion of the greater trochanter
- Soft tissue is contained in both ends of the Neck Region of Interest
- The Neck Region of Interest (ROI) is perpendicular to the femoral neck.
- The Neck Region of Interest (ROI), ideally, does not contain any portion of the ischium. If the ischium is include in the Neck Region of Interest (ROI), the program automatically types the bone as Neutral.
Spine Scan
The technician adjusts the image so that the bone edges can be clearly seen and makes sure that the bone and tissue are correctly identified by the analysis software. The technician ensures the region of interest is correctly positioned as follows:
- Make sure the intervertebral markers are between the vertebral bodies
- Make sure the intervertebral markers are located at the lowest point of the bone density as indicated on the bone profile.
GE Lunar DXA systems and related software, such as enCORE, are under copyright. ©2010 General Electric Company. All rights reserved. GE and GE Monogram are trademarks of General Electric Company. GE Healthcare is a division of General Electric Company.
Personnel and Training Required
Technicians may or may not be certified radiology technologists depending on state laws. Regardless of formal education, study personnel should receive specialized training in the survey protocol and basic techniques of the operation of the specific make and model of the dual-energy X-ray absorptiometry (DXA) machine used.Device-specific education and training should be provided to the operators and interpreters prior to clinical use. Quality control procedures should be performed regularly.
Equipment Needs
Several dual-energy X-ray absorptiometry (DXA) machines are marketed commercially. According to the International Society for Clinical Densitometry (2007), "Bone density measurements from different devices cannot be directly compared." Because there are many manufacturers, models, and software versions of the DXA machine, investigators must report those they are using. Regular scans (i.e., weekly at a minimum for large studies) using DXA phantoms are recommended as an independent assessment of system calibration. Studies that use more than one scanner device should also implement a plan to monitor inter-scanner differences at baseline and at regular intervals during the study.
Note: Manufacturers of DXA equipment are constantly striving to improve and update both their equipment and software with the latest technological advances. The recommended equipment for this protocol in PhenX is current as of June 2009. Please refer to the DXA specifications for your model number to ensure that the level of information collected is compatible with the PhenX protocol.
Requirements
Requirement Category | Required |
---|---|
Major equipment | Yes |
Specialized training | Yes |
Specialized requirements for biospecimen collection | No |
Average time of greater than 15 minutes in an unaffected individual | Yes |
Mode of Administration
Noninvasive radiologic assessment
Lifestage
Adult, Senior
Participants
Adults, ages 18 years and older
Selection Rationale
The Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam was selected as the best practice methodology for the determination of bone density at the hip and lower spine by dual-energy X-ray absorptiometry. The Framingham Heart Study is a long-running, large prospective cohort study to determine the characteristics that contribute to cardiovascular disease. The Framingham Heart Study has included an osteoporosis component since 1988.
Language
Chinese, English
Standards
Standard | Name | ID | Source |
---|---|---|---|
Logical Observation Identifiers Names and Codes (LOINC) | Spine - femur bone density DXA proto | 62910-5 | LOINC |
Human Phenotype Ontology | Abnormal bone mieral density | HP:0004348 | HPO |
caDSR Form | PhenX PX170701 - Spine And Femur Bone Density By Dualenergy Xray Absorp | 6186337 | caDSR Form |
Derived Variables
None
Process and Review
Not applicable.
Protocol Name from Source
Framingham Osteoporosis Study, Generation 3, Musculoskeletal Exam
Source
U.S. Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, and Boston University. (May 2008–2010). Framingham Heart Study (FHS). Framingham Osteoporosis Study Generation 3 Musculoskeletal Exam manual. Rockville, MD: U.S. Department of Health and Human Services.
General References
International Society for Clinical Densitometry. (2007). Official positions and pediatric official positions of the International Society for Clinical Densitometry. Available at
http://www.iscd.org/Visitors/pdfs/ISCD2007OfficialPositions-Combined-AdultandPediatric.pdf.
Bonnick, S. L. (2009).Bone densitometry in clinical practice: Application and interpretation, 3rd ed. Humana Press.
Protocol ID
170701
Variables
Export VariablesVariable Name | Variable ID | Variable Description | dbGaP Mapping | |
---|---|---|---|---|
PX170701_Birth_Control | ||||
PX170701070000 | Did you use one of the following forms of more | N/A | ||
PX170701_DXA_Machine_Manufacturer | ||||
PX170701080200 | Dual-energy x-ray absorptiometry (DXA) more | N/A | ||
PX170701_DXA_Machine_Name | ||||
PX170701080100 | Dual-energy x-ray absorptiometry (DXA) more | N/A | ||
PX170701_Femur_Scan_ID | ||||
PX170701090000 | Femur scan image name (ID) | N/A | ||
PX170701_Intercourse_In_Last_Week | ||||
PX170701060000 | Have you had sexual intercourse in the past more | N/A | ||
PX170701_Last_Menstrual_Period | ||||
PX170701030100 | If no, when was your last menstrual period? | Variable Mapping | ||
PX170701_Pregnancy_Test_Required | ||||
PX170701040000 | Pregnancy Test Required? | N/A | ||
PX170701_Pregnancy_Test_Result | ||||
PX170701040100 | If yes, Result: | Variable Mapping | ||
PX170701_Pregnant | ||||
PX170701010000 | Are you pregnant? | Variable Mapping | ||
PX170701_Spine_Scan_ID | ||||
PX170701100000 | Spine scan image name (ID) | N/A | ||
PX170701_WomenOver55_Hysterectomy | ||||
PX170701030000 | For women >55 years old: Have you had a more | N/A | ||
PX170701_WomenUnder55_Hysterectomy_Tubal_Ligation | ||||
PX170701020000 | For women <55 years old: Have you had a more | N/A |
Measure Name
Spine and Femur Bone Density by Dual-Energy X-ray Absorptiometry
Release Date
November 12, 2010
Definition
This is a measure to obtain spine and femur dual-energy X-ray absorptiometry (DXA) scans to assess bone mineral density.
Purpose
Bone density (or bone mineral density; BMD) is a risk factor for fracture, and is often used to categorize individuals into disease categories such as osteoporosis or osteopenia.
Keywords
arthritis, dual-energy X-ray absorptiometry, DXA, X-rays, radiograph, body composition, bone density, bone mineral density, BMD, DEXA, osteoporosis, osteopenia, National Health and Nutrition Examination Survey, NHANES, The International Society for Clinical Densitometry, ISCD, Framingham Osteoporosis Study, Framingham Heart Study, FHS, Hologic, gerontology, aging, geriatrics, bone, joint
Measure Protocols
Protocol ID | Protocol Name |
---|---|
170701 | Spine and Femur Bone Density by Dual-Energy X-ray Absorptiometry |
Publications
There are no publications listed for this protocol.