Archive for the ‘Clinical Trials’ 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
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