Posts Tagged ‘Osteoporosis’
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
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
Treat to Target of NO NEW FRACTURES. How do we find that target? DXA >-2.5 is a start. Fragility fractures increase new fracture risk. FRAX adds many more risk factors to the calculation and TBS refines FRAX.
Vertebral Fracture Assessment (VFA) looks at the spine from the side and independently identifies additional fracture risk. This can be done on a DXA machine or by x-ray. A single vertebral compression fracture of 25% or more pre-empts DXA, BMD, and FRAX in diagnosing Clinical Osteoporosis and recommending treatment.
VFA should be done because the majority of vertebral compression fractures are first noticed by x-ray or DXA VFA imaging. If you do not personally view the images, be sure the radiologist specifically checked for vertebral deformities as described by Genant.
I recently published my retrospective review of 1259 sequential first time VFA patients in Endocrine Practice 2017:23:1375-8.
VFA identified many patients not identified as high fracture risk (Clinical Osteoporosis) by DXA or fragility fracture or height loss or kyphosis or FRAX.
We should consider including VFA in every first time Complete Bone Health Evaluation.
And how should we treat? Next time…
Jay Ginther, MD