Archive for the ‘Evaluation and Screening’ Category
FDA approved clinical trials are a well established way to gain access to medications not yet available to the general public. Most people have heard of individuals taking experimental treatments for cancers or HIV or Ebola on the news. But there is another type of FDA trials to which we now have access.
Osteoporosis medications are first tested and approved for postmenopausal women only. Men are 20-25% of the individuals with osteoporosis. However, approval for men takes a separate clinical trial. Therefore, often men have to wait an additional 3-5 years for access to a medication we know should work but has not yet been officially approved for men.
Participating in the clinical trial for men allows men with osteoporosis access to the new medication years earlier – and at no cost. The anabolic medication Tymlos (abaloparatide) is currrently conducting a national clinical trial for men. The intake process is detailed to be certain that only those men likely to benefit and not be harmed are included.
Cedar Valley Bone Health Institute of Iowa and North-East Iowa Medical Education Foundation are a test site for the clinical trial of Tymlos (abaloparatide) for Men. You may qualify. The qualification testing is all at no cost to the patient.
If you are close enough to Waterloo, IA to come in every 3 months for testing, contact us at 319-233-2663 (Shari) or 319-272-2539 (Kayla) to apply for the clinical trial.
For a bone health evaluation and treatment plan for men or women call 319-233-2663. If you are a man needing anabolic medication we will also proceed to evaluation for the clinical trial.
Jay Ginther, MD
Treat to Target of NO NEW FRACTURES. How do we find that target? DXA >-2.5 is a start. Fragility fractures increase new fracture risk. FRAX adds many more risk factors to the calculation and TBS refines FRAX.
Vertebral Fracture Assessment (VFA) looks at the spine from the side and independently identifies additional fracture risk. This can be done on a DXA machine or by x-ray. A single vertebral compression fracture of 25% or more pre-empts DXA, BMD, and FRAX in diagnosing Clinical Osteoporosis and recommending treatment.
VFA should be done because the majority of vertebral compression fractures are first noticed by x-ray or DXA VFA imaging. If you do not personally view the images, be sure the radiologist specifically checked for vertebral deformities as described by Genant.
I recently published my retrospective review of 1259 sequential first time VFA patients in Endocrine Practice 2017:23:1375-8.
VFA identified many patients not identified as high fracture risk (Clinical Osteoporosis) by DXA or fragility fracture or height loss or kyphosis or FRAX.
We should consider including VFA in every first time Complete Bone Health Evaluation.
And how should we treat? Next time…
Jay Ginther, MD
Our goal is NO NEW FRACTURES. Cancellous (spongy, like the ends of the drumstick) bone should be a strong latticework of struts called trabeculi. Clinical Osteoporosis, an increased fracture risk, occurs when some of the struts disappear.
Trabecular Bone Score (TBS) evaluates the spongy bone in the DXA images of the vertebrae (spine) looking for irregularities. When TBS finds uneven bone mineral density within the spine DXA, that indicates a higher fracture risk, regardless of the total BMD.
Adding the TBS feature to a DXA machine allows the quality of bone in the spine to influence the FRAX score, just like the BMD in the femoral neck part of the hip influences the FRAX score. Adding TBS detects more patients at high fracture risk who should be treated to avoid fractures.
Diabetes increases a person’s fracture risk for any given DXA BMD or T-score. Controlled diabetes adds about the same risk as rheumatoid arthritis, so we usually check that box in FRAX. Uncontrolled diabetes is more serious requiring further adjustment to FRAX.
FRAX is pre-empted by a hip fracture. “Do not pass GO, do not collect $200, start a pharmaceutical” Vertebral (spine) Fracture is the same, but the majority of spine fractures are not noticed clinically. “Morphometric” (first noticed on x-ray) vertebral fractures count, but how to find them?
VFA next time
Jay Ginther, MD