Archive for the ‘Medications’ Category
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
Clinical Osteoporosis 2017, NOF and ISCD joint meeting had a different emphasis this year. Fracture Risk, rather than Bone Mineral Density (BMD) is now the key metric. Several speakers emphasizd the importance of VFA in making the diagnosis of Clinical Osteoporosis. This is something I have presented in poster exhibits 2015, 2016 and 2017. I am now mainstream!
“Treat to Target” was the big new message this year. We should set a target of decreased Fracture Risk for each patient and alter treatment until we reach it. This has been routine for years in diabetes, hypertension, cholesterol, etc. This is recognition that Osteoporosis is a chronic disease that we can control, but never cure, just like many others.
Take Control Naturally is the necessary first step, as I have outlined over the last few months. This is often sufficient for prevention and in mild disease.
Advanced Osteoporosis, especially after fragility fractures, or vertebral compression fractures seen on VFA, is usually beyond nutrition and exercise only. This will usually require medications to significantly reduce fracture risk.
The huge change is the recommendation to use an Anabolic medication first, to markedly reduce fracture risk, when BMD is very low or multiple fractures have already occured. Then follow up with an Antiresorptive to maintain a low fracture risk. Traditionally Medicare and other insurances have demanded we try Antiresorptives first to maintain bone as it is, even when multiple fractures have proven the bone to NOT be good enough at curent BMD.
We are entering a new age of Fracture Prevention!!
Jay Ginther, MD
Recent studies have shown that the order in which we use osteoporosis medications matters. Traditionally most docs have used Antirsorptives first to preserve bone. All osteoporosis medications except one are Antiresorptives. Only when that failed, would they consider the Anabolic medication, Forteo, to build new bone.
As a practicing orthopedic surgeon, I started treating osteoporosis in the worst of my fracture patients. It was obvious that they needed to build bone first since there was very little bone to preserve. Therefore, I usually started with the Anabolic, Forteo. Once I had built up the bone, I preserved that improved bone with an Antiresorptive osteoporosis medication.
As the National and International Osteoporosis Foundations, (NOF and IOF) are now focusing on preventing second fractures, many more practioners are treating patients with one or more fractures. They are facing the dillema of how to prevent fractures in bone that is not good enough. None of the Antiresorptives work as well in patients with multiple fractures as they do in patients who have not yet fractured.
This year studies have shown that using Forteo after an Antiresorptive usually results in Forteo taking several months to overcome the previous slowing of bone turnover, Therefore, 2 years of Forteo results in less improvement when used AFTER the Antiresorptives tested, than we normally see in a patient who uses Forteo first.
At NOF and IOF this year speakers suggested that we change our approach. They suggested using an Anabolic first, and an Antiresorptive second should be the standard sequence for best results.
Would you rather only trying to preserve your bones after they have proven insufficient in multiple fractures? Or would you want to improve your bone first, and then prserve that improved bone matrix and improving BMD?
Do everything you can to improve and preserve your Bone Health.
Jay Ginther, MD