National Bone Health treatment goals are changing for those patients with high fracture risk. Simply preserving bones already at a too high fracture risk never made much sense to this former orthopedic surgeon. Now the national leadership is stressing the need to lower fracture risk first, then preserve bones at a lower level of fracture risk.
We now have 3 anabolic medications which substantially lower fracture risk by increasing the thickness and strength of bone structure: Teriparatide (Forteo), Abaloparitide (Tymlos), and Romosozumab (Evenity). They all decrease fracture risk substantially more than the antiresorptive (preserving) medications alone. The difference in fracture risk grows for up to 5 years. After that the difference in fracture risk between anabolic meds followed by preserving meds vs. preserving meds alone remains the same.
Calcium can take up to 3 additional years to collect in newly formed bone matrix. DXA shows calcium in bone (Bone Mineral Density). Much of the increased BMD can only be seen on DXA after the anabolic med is completed and the antiresorptive med is started.
All of the anabolic medications must be followed by antiresorptive medication to preserve the gains made by the anabolic. No medication to grow or preserve bone can work without adequate nutrition in the form of absorbable calcium, vitamin D3, protein and other vitamins and minerals.
Jay Ginther, MD
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
American Society for Bone & Mineral Research Annual Meeting 2019 starts tomorrow.
Jon Hennings, ARNP and I will be there hoping to see and hear the latest studies about the new medications Tymlos and Evenity.
We always learn a lot.
Jay Ginther, MD
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