Posts Tagged ‘anabolic’
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
Treat to Target means aiming for NO NEW FRACTURES. As discussed last time, the original target was to maintain Bone Mineral Density (BMD) at the level first tested. 25 years ago that was amended to be a T-score of -2.4 or higher, since “osteoporosis the test result” was set at -2.5.
But what if you already have fractured? Clinical Osteoporosis the diagnosis is a T-score of -1.5 plus a “Fragility Fracture” acquired in any fall from standing height, even on ice. That is because for the first year after a fracture your risk is 5 times normal. Your risk decreases to 2 times normal after 5 years, but always is higher after a fragility fracture.
If your Fragility Fracture was a Hip Fracture, you have Clinical Osteoporosis regardless of DXA BMD and T-score. You are at high risk of future fracture, especially of the other hip. You should start treatment to prevent a new fracture. At the very least you need to optimize calcium, vitamin D3, protein, and multiple vitamins & minerals intake.
If you also need a pharmaceutical, it should be one which can raise your T-score above -2.5 if you have no fractures, and above -1.5 if you already have a fracture. That usually means considering an anabolic. Your goal is NO NEW FRACTURES.
FRAX next time.
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
University of Wisconsin hosts biennially the Bare Bones of Osteoporosis Care Symposium. This year the Wisconsin Bone Club followed the symposium.
Felicia Cosman, MD from Helen Hayes in New York was the guest speaker at both. She expanded on the new thoughts and guidelines presented at NOF in April. These were a complete change of approach from just a few years ago.
Treat to Target. Anabolics first to build bone and then preserve with Antiresorptives. Reconsider VFA for all first time DXA evaluations.
More detail about these in the weeks to come.
Jay Ginther, MD