Posts Tagged ‘Prolia’
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
Recent studies have shown that the order in which we use osteoporosis medications matters. Traditionally most docs have used Antirsorptives first to preserve bone. All osteoporosis medications except one are Antiresorptives. Only when that failed, would they consider the Anabolic medication, Forteo, to build new bone.
As a practicing orthopedic surgeon, I started treating osteoporosis in the worst of my fracture patients. It was obvious that they needed to build bone first since there was very little bone to preserve. Therefore, I usually started with the Anabolic, Forteo. Once I had built up the bone, I preserved that improved bone with an Antiresorptive osteoporosis medication.
As the National and International Osteoporosis Foundations, (NOF and IOF) are now focusing on preventing second fractures, many more practioners are treating patients with one or more fractures. They are facing the dillema of how to prevent fractures in bone that is not good enough. None of the Antiresorptives work as well in patients with multiple fractures as they do in patients who have not yet fractured.
This year studies have shown that using Forteo after an Antiresorptive usually results in Forteo taking several months to overcome the previous slowing of bone turnover, Therefore, 2 years of Forteo results in less improvement when used AFTER the Antiresorptives tested, than we normally see in a patient who uses Forteo first.
At NOF and IOF this year speakers suggested that we change our approach. They suggested using an Anabolic first, and an Antiresorptive second should be the standard sequence for best results.
Would you rather only trying to preserve your bones after they have proven insufficient in multiple fractures? Or would you want to improve your bone first, and then prserve that improved bone matrix and improving BMD?
Do everything you can to improve and preserve your Bone Health.
Jay Ginther, MD
You have started taking Osteoporosis Medication. You think you have entirely eliminated your Fracture Risk. Then, WHAM – you have a Fracture! What went wrong?
It is time to re-evaluate. There are many possible reasons for your fracture.
First, all osteoporosis medications gradually become effective over months. Therefore, if you fracture within the first few months, there has not been enough time for it to become fully effective.
By two to three years, all osteoporosis medications Decrease Fracture Risk by 1/2 to 2/3. That is very good, but not perfect.
Second, you need to be sure you are getting enough Absorbable Calcium in 3 doses of 400-500 mg In Foods or With Foods – every day. You need to have a high enough Vitamin D level to absorb the Calcium. You need Magnesium too – a Multiple Vitamin and Mineral (taken with a full meal) should be enough. You also need Protein (1gram per kg of body weight). If you had Secondary HyperParathyroidism, it must be resolved.
Third, Bisphosphonate pills are sometimes not absorbed adequately. When they work, we actually absorb less than 1% of the drug taken. If this is a problem, Reclast or Prolia can get around the absorption issue. Of course, skipped doses do not work at all.
Fourth, there may be other issues causing fragility. A Complete Bone Health Evaluation will usually identify Diabetes, HypoThyroidism, Colitis, Irritable Bowel Syndrome, Lactose or Gluten sensitivities, etc. These need to be fixed too.
Finally, your Osteoporosis may be too severe to be ideally treated with Antiresorptives. Very low BMD and T-scores, multiple Fragility Fractures, Vertebral Fracture Deformities (especially multiple) are all indications that you probably should start with the Anabolic, Forteo, to build up your Bone Matrix enough that a Antiresorptive can then be the best treatment.
Fracture while on medication? Time to re-evaluate. Then modify your program if needed.
Jay Ginther, MD
Several patients have concerns about oral surgery while taking Prolia. This is not a problem – if you follow guidelines.
Prolia is different from other Antiresorptives. Prolia does not accumulate in bone. 5 to 6 months after your last dose, Prolia has lost its effect of slowing bone turnover. Therefore, it is safe to proceed with surgery on bone (including dental surgery) 6 months after your last dose.
Patients worry about OsteoNecrosis of the Jaw (ONJ), but this is very rare. In fact ONJ virtually never occurs without a tooth extraction or serious periodontal disease. Even then, it is rare unless you also have cancer, have poorly controlled diabetes, or are seriously Deficient in Vitamin D3, or Calcium, or Protein intake.
Elective Orthopedic Surgery timing is the same. If you need a Total Hip Replacement (THR) or Total Knee Replacement (TKR), schedule the surgery for 6 months after your last dose of Prolia.
Any time you plan to have surgery on bone, you should Optimize Your Bone Health First. Get a Complete Bone Health Evaluation. Optimize your Vitamin D level (at 40 to 80 ng/ml). Optimize your Calcium intake in foods and supplements combined (at 400 to 500 mg at all 3 meals daily). Optimize your daily Protein intake (1 g Protein for every kg body weight).
Sometimes you will also need the Anabolic, Forteo, to increase bone matrix and improve healing. More about that another time.
Get the best possible result from orthopedic or dental surgery. Wait 6 months after Prolia, and do your part to optimize your bone health.
Jay Ginther, MD