Archive for the ‘Medications’ Category
Recently I wrote about our participation in a clinical trial offering the anabolic Tymlos (Abaloparatide) to men. Now we have been approved for participation in another Tymlos (Abaloparatide) trial – this one for women. Currently Tymlos is available to women as a daily shot. The new delivery system is a patch applied to the skin for 5 minutes daily. That is far more convenient than a shot.
The FDA compliant trial is being run by the Northeast Iowa Family Practice Center. They have years of experience with clinical trials. Clinical trials always have strict inclusion and exclusion criteria requiring extensive screening, interviews and multiple testings. All screening is free to the participant. If you are accepted into the trial, all treatment is also at no charge.
All participants will receive the FDA approved anabolic (increases bone matrix) medication Tymlos (Abaloparatide). Participants are randomized to the standard injection or the new patch.
Our participation in the study is that Bone Health will be doing all screening and quarterly study DXAs and ADI (Advanced Diagnostic Imaging of Iowa) will be doing the spine x-rays. We are also screening our own patients for potential to be study participants.
Remember that anabolic medications Forteo (Teriparatide), Tymlos (Abaloparatide), and Evenity (Romosozumab), primarily stimulate new bone formation. Antiresorptives Fosamax (Alendronate), Actonel/Atelvia (Risendronate), Boniva (Ibandronate), Reclast (Zolendronate), Evista (Raloxifene), and Prolia (Denosumab), primarily preserve bone.
Of course, all medications require proper nutrition to work well.
Jay Ginther, MD
We now have a third anabolic medication to build new bone. Evenity is really different from the other anabolics, Forteo (teriparatide) and Tymlos (abaloparatide). Forteo and Tymlos are daily shots based on the human hormones PTH and PTHrP. Evenity is an antibody to the human hormone sclerostin.
Sclerostin controls bone formation by telling osteoblasts to stop making new bone, and telling osteoclasts to gobble up old bone. This results in stable bone turnover remodeling (until menopause decreases control over the osteoclasts and they go wild). Evenity suppresses sclerostin.
Evenity markedly increases new bone matrix formation within the first month.However, the ability of Evenity to increase new bone formation diminishes month by month until it is mostly gone by one year. Therefore, it has been approved for use for only one year at a time. Like Forteo and Tymlos, Evenity must be followed by an antiresorptive to preserve the increase in bone.
Evenity also suppresses bone resorption by the second month. This is a less dramatic action, but it continues at the same level to the end of the year. The net result is a significant increase in bone matrix by the end of the year, in the same general order of magnitude as Forteo and Tymlos.
Evenity is a monthly shot into the subcutaneous fat on the back of both arms by a healthcare professional.
There is a possibility that Evenity may increase cardiac events in persons who have had a recent stroke or heart attack. This was found in only one of the 3 clinical trials of Evenity.
Preauthorization is required for insurance to cover Evenity. Most insurances will probably cover it within the first 3-12 months. More next time.
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