Posts Tagged ‘Osteoporosis medication’
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
Our goal is NO NEW FRACTURES. Therefore, Treat to Target means a FRAX score of <20% for “major osteoporotic” and <3% for hip fracture. Alternately, T-score of better than -1.5 if there are any fractures.
Antiresorptives do not substantially increase bone mass or BMD. While a 3-5% BMD improvement can be seen when a long term deficiency in calcium absorption is corrected, the function of an antiresorptive is to maintain current bone mass.
If you want to substantially increase bone mass, you must use an anabolic medication. We now have 2. Forteo (teriparatide) has been available for 15 years. Tymlos (abaloparatide) was approved late last spring, but has only achieved good coverage by a majority of insurance companies in the last month.
Both can be given for up to 24 months. Both must be followed by an antiresorptive to avoid loss of gains. Both will show continued improvement in BMD for up to 3 years after switching to an antiresorptive because calcium takes up to 3 years to fully accumulate in new bone matrix formed by an anabolic.
Both should NOT be given to anyone with open growth plates, Paget’s, radiation to bone, cancers which have or could spread to bone, elevated bone specific alkaline phosphatase other than from fracture healing, or pregnant or nursing women.
Tymlos is approved for postmenopausal women only. It does not stimulate bone turnover significantly and therefore shows faster BMD increase initially in the hip. It has not been tested for use after antiresorptives.
Forteo is approved for men and women with osteoporosis which is “age-related”, or from steroid use, or from idiopathic hypogonadism. Forteo significantly increases both osteoblast and osteoclast activity, thereby stimulating bone turnover, which is often suppressed after long-term antiresorptives. Forteo is the default treatment for ONJ and AFF.
If you are dealing with vertebral fractures on VFA, or really low BMD on DXA, or with multiple fragility fractures, you need an ANABOLIC FIRST, to decrease fracture risk. Then follow with antiresorptives to maintain a low enough fracture risk.
Remember, even these medications will fail without proper nutrition.
jay Ginther, MD
The FDA approved Tymlos (Abaloparatide) in June for use in women diagnosed with osteoporosis. Unfortunately most patients are unlikely to obtain insurance coverage for Tymlos until January or February 2018.
Tymlos is an anabolic, which means that it can stimulate osteoblasts, the cells that make new bone matrix. Until now only Forteo (Teriparatide) has been available to do that. Having a second option will be helpful.
Tymlos is similar to Forteo, yet there are distinct differences. Tymlos is almost pure osteoblast stimulation which means that BMD rises faster in areas with cortical bone, such as the hip. This potentially makes it a better choice for women never exposed to antiresorptive bisphosphonates like Fosamax (Alendronate), Actonel (Risedronate), Boniva (Ibandronate), and Reclast.
Tymlos is a daily shot (like insulin), but does not require refrigeration. It is approved for up to 24 months use and must be followed by an antiresorptive in order to not lose the benefits gained.
Patients with a single fracture of hip, or multiple fractures of other bones including spine, or with a BMD well below -2.5, or a FRAX score well above 20%and 3.0%, should be considered for an anabolic. Now we have another choice available.
For now Tymlos is approved for women only and osteoporosis only. We look forward to the FDA adding men and other indications in coming years.
Meanwhile, we wait for insurance coverage to make it affordable.
Jay Ginther, MD
Treat to Target has been standard for chronic diseases like high blood pressure and diabetes for decades. These are chronic diseases, more common as we get older, that we can control with diet, exercise, and eventually medication. We cannot cure them.
Bone health joins the Treat to Target club in 2017. Increased Fracture Risk (Clinical Osteoporosis) is a chronic disease, more common as we get older, that we can control with diet, exercise, and eventually medication. We cannot cure Increased Fracture Risk, so treatment of some sort is necessary “forever”.
What is our target? Traditionally it has been maintaining the T-score found at the first assessment. This does not necessarily make sense, especially if there already are fractures. The target should be NO NEW FRACTURES. This is a game changer.
This means that we are aiming for a Bone Mineral Density T-score higher than -2.5 in someone who has not yet fractured. How we get there requires a new approach to medications, once we have reached the limits of Take Control Naturally detailed in previous posts.
This also means we need to check the VFA for previous Vertebral Compression Fractures, most of which go un-noticed, mistaken for pulled muscles. (I did that a few years back.)
THE TARGET IS NO NEW FRACTURES.
Jay Ginther, MD