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Posts Tagged ‘Abaloparatide’

If you fracture, your risk of a second fracture within a year is 3 to 5 times as great!  If that first or second fracture is a hip, you have a 25% chance of dying and a 25% chance of spending the rest of your life in a nursing home.  Scary.

Sometimes nutrition and lifestyle changes are enough.  Often medications are needed to effect real improvement.  The anabolic medications Teriparatide (Forteo), Abaloparatide (Tymlos), and Romosozumab (Evenity) not only prevent further fractures by increasing bone mass, but also speed healing.  The antiresorptive medications decrease fracture risk by preventing bone loss.

The NOF video at https://vimeo.com/267839997 discusses the likelihood of benefit in relation to the very small risk of harm from antiresorptive medications.

Understand the relative risks of taking a medication compared to the relative risks involved in not taking a medication.

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

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

Evenity is a Really Different Anabolic

August 8, 2019 @ 6:42 pm
posted by Dr Ginther

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