Bone Densitometry Center of Excellence
The Atlanta Research Center is an internationally recognized center of excellence in the measurement of bone density in human subjects during phase 2, 3 and 4 clinical trials. ARC has worked with virtually all current and past DXA coordinating centers beginning in early 1990s with Synarc, the first company providing centralized DXA services. Recently we have worked on osteoporosis trials with Nordic Bioscience and BioClinica.
We have always deployed the top-of-the-line Hologic DXA products at the ARC beginning in 1986. We were the first center to have a DXA in the Southeastern US. In 1995 we were the first to upgrade to the Hologic 4500A with whole body, Body composition analysis, lateral DXA, and forearm. Since then, we have maintained our technological standard staying within the 4500A table and software suite but moving through its various iterations to our current Discover 4500A DXA.
ARC as DXA Vendor for other Research Centers
It has been our pleasure to serve as a vendor for sites in the Atlanta area whose protocols require research grade Spine, Hip or Forearm DXA or body composition analysis. We are skilled at accommodating the scheduling needs of these other sites subjects and can see them here at our center quickly with very little waiting and no paperwork. Of course, we are thoroughly conversant and comfortable working with all the DXA coordinating centers and complying with their exacting procedures and timelines precisely.
Body Composition Analysis by DXA
BCA measured by DXA is the gold standard for measurement of body fat mass surpassing the Archimedes method of underwater weighing for this purpose. With BCA by DXA, you get a color-coded visual image of the where the body fat, muscle, and bone is together with a calculation of total values for each parameter.
The print out provides long a breakdown by region of interest; head, right arm, left arm, torso, abdominal, right leg, left leg, etc. This breakdown is provided in grams of fat, muscle, and bone and is very accurate and precise. This permits meaningful repeat comparison measurements for statistical analyses.
Bone Biopsy after Double Tetracycline Labeling for Static and Dynamic Histomorphometry
Grattan Woodson, M.D., the ARC PI is skilled at this procedure. He learned to do bone biopsies from watching Robert Weinstein, M.D. when he was a medical student at MCG rotating through endocrinology. His brief exposure to the dynamic Dr. Weinstein ignited Dr. Woodson’s life-long interest in metabolic bone disease and career in osteoporosis. He was experienced doing bone marrow biopsies but that procedure used a 3 mm Jamshiti needle is obtained from the sacrum and is not a transpelvic through and through biopsy. Dr. Woodson taught himself to do transiliac bone biopsies practicing on cadavers in the Grady morgue. Once proficient enough and accompanied by a friendly orthopedist who was the actual attending surgeon, he did his first few cases closely following the instructions provided by writings of Dr. Harold Frost and others. By 1985, he was fully trained and taught the procedure to Nelson Watts, M.D. his research partner at Emory who together started the osteoporosis research program. Our first research study was with the bisphosphonate Didronel and bone biopsies were required on all 75 patients we enrolled in the study before and after treatment. Dr. Watts and I became expert at the procedure by the end of the 3-year trial. Since then, Dr. Woodson has provided bone biopsies for a number of osteoporosis registration trials and other osteoporosis studies.
The ARC has established an out patient surgical procedure suite where the biopsies are performed. We have a primary surgical procedure assistant and a secondary assistant assigned to all surgical procedures at the ARC that are trained in the procedures we offer, the supply protocol for each, and the possible adverse events that the subject might encounter during a procedure. The procedure room is outfitted with fully stocked equipment and medical cabinet, oxygen, IV setup, crash cart, timers, and eraser boards for keeping real-time local anesthesia total records. Our facility is fortunately located 2 blocks away from the Brookhaven Fire Department where our EMS is stationed.
Dr. Woodson always uses a hand operated Bordier trephine, made in Lyon, France with a 0.9 mm internal diameter to obtain the biopsy. The specimen is taken from the traditional location from 2 cm inferior and 2 cm posterior to the superior anterior iliac spine.
We use lidocaine with epinephrine to achieve local anesthesia of the superficial tissues along the anterior approach to the external iliac wing and posteriorly down the inside shelf of the iliac under the periosteum where we anticipate the trephine will exit. Prior to the case, we commonly administer a low dose of Versed IV as a sedative and an oral pain medication, tramadol and acetaminophen. This procedure does not require general anesthesia.
Dr. Woodson is mindful of the need to obtain a complete specimen that is not crushed and has intact external and internal pelvic cortices. This quality standard is required for the most to be obtained from histomorphometric analysis of the bone biopsy specimen.
To measure dynamic bone parameters requires the subject to take two courses of one of the members of the fluorescing tetracycline family separating by a definitive period. Drugs from the tetracycline family have been the traditional choice for this purpose because they are cheep, safe, taken orally, and fluoresce brightly under ultraviolet light. On the down side, they must be taken on an empty stomach several times a day. A common regimen is tetracycline HCl 250mg capsules 1 p.o. QID for 3 days, wait 14 days, then repeat tetracycline HCl 250 mg p.o. QID x 3 days then stop. The biopsy is usually obtained 7 to 14 days after the last dose of tetracycline.
From beginning to end the procedure takes about 2 hours.
Our research staff is IATA certified to ship study specimens to central laboratories for processing.
The bone biopsy laboratory that I have had the most experience with is Robert Recker’s at Creighton University. His laboratory provides 70% ethanol fixative in sterol plastic screw top containers and padded transport boxes with shipping labels that are used to directly send the specimens to his laboratory. This is the preferred procedure, in my opinion, for such a high value specimen.
The other laboratory with expertise in processing bone biopsy specimens for clinical trials is Mayo Clinic in Rochester, Mn. They have processed my clinical specimens for years and do a magnificent job. They can be contacted at this address: http://www.mayo.edu/research/labs/bone-histomorphometry/overview
Our PI, Dr. Woodson is skilled in performing this procedure having done it for multiple research trials and in his clinical practice.
Ultrasound Measurement of Vasodilatation of the Brachial Artery
Our ultrasound technologist performed this procedure for research study of how long it vasodilation took to recover in women who used tobacco who were also on estrogen compared with women who smoked not on estrogen.
Carotid Intima Medial Thickness Measurement
We learned this procedure for a cardiovascular comparator study of atrovastatin and pravastatin. Dr. Woodson found the procedure so useful clinically for diagnosis and management of patient’s with hypercholesterolemia that we perform it routinely now on our primary care patients with this condition.
Ankle Pressure Index
This simple low technology technique uses blood pressure cuffs and a Doppler to detect peripheral artery disease. It is easy to do and can be performed by a CRC after a short in-service.
We maintain standard EKG equipment. Our office equipment is maintained and calibrated by Medical Maintenance, Inc http://www.medicalmaintenance.com/equipment/
Abdominal Liposuction for Harvesting of Autologous Mesenchymal Stem Cells for Treatment of Osteoarthritis of the Knee
Dr. Woodson has developed an interest in treatment of certain chronic muscluoskeletal diseases with autologous mesenchymal stem cells and platelet rich plasma harvested from the visceral in the abdominal wall. You can learn more about this technology and the procedure by going to our website www.JointRegen.net.