http://www.effectivehealthcare.ahrq.gov/ehc/products/160/1007/CER53_LowBoneDensity_FinalReport_20120329.pdf

Pain is one of the geriatric syndromes known to cause impaired mobility, reduce quality of life, contribute to falls, increase the risk for depression, and lead to adverse drug events when analgesics of all types are prescribed to manage the pain. As with all geriatric syndromes, the pain may be assumed to be a “normal part of aging” and lead to inappropriate treatment. NSAIDs are known to cause gastrointestinal bleeding, hypertension, precipitate heart failure and cause kidney damage. NSAIDS can interact with warfarin and increase the risk of bleeding. Opiates can increase the risk of falls and also that of delirium. So if a bisphosphonate is the cause of bone and joint pain, followed by the prescribing of analgesics, this is a prescribing cascade that is worthy of attention.

If you suspect bone or joint pain from a bisphosphonate, consideration should be made to hold the bisphosphonate and reevaluate for symptoms of pain. This should occur ONLY after having a discussion with your physician. For health care practitioners, prescribing cascades are a very real problem in geriatric medicine and careful consideration should be made to ensure unnecessary drug treatment does not occur by assuming the drug to be the cause until proven otherwise.

Prolia (denosumab) is a monoclonal antibody which is very effective at increasing bone density, at least as effective as bisphosphonates and Forteo. It is easily administered by a subcutaneous injection (fatty tissue under the skin) twice a year. Many of the side-effects seen with bisphosphonates are not there, and the complexity of taking an orally administered bisphosphonate clearly disappears with an injection. The drug-drug interaction between proton pump inhibitors, e.g. Prilosec and others, is non-existent, which otherwise render bisphosphonates ineffective. It also doesn’t have the risk for renal failure, as is seen with Reclast injection. There are some data that suggest eczema and serious skin infections may occur, and more needs to be known about that. However, Prolia has been on the market, for other uses and other names for about 8 years. So the safety data are quite well established. For those that have very low bone density, and are at high fall and fracture risk, Prolia just might be a very reasonable alternative, to combine with an effective fall prevention strategy.

One can then ask the question about whether the PPI is still needed, since it is not uncommon that PPIs are used well beyond their needed time to benefit. However, it can be challenging to stop a PPI due to rebound hyperacidity when stopping the drug abruptly, thereby giving one the impression they still need the drug. A slow taper is warranted when trying to stop a PPI. If a PPI is needed, then perhaps there are other osteoporosis therapies that do not interact with PPIs. We have Reclast (zoledronic acid) that is given intravenously. But that seems like a drastic step  to avoid a drug interaction. There is Prolia (denosumab), a monoclonal antibody that has very good fracture risk reduction data. It is a subcutaneous injection that is given twice a year and without the kidney issues that exist with Reclast.

The real benefit in knowing of this drug interaction is that users of the two drugs then know not to rely upon the bisphosphonate thereby leading the user and their physician to find an effective strategy to reduce fracture risk. This then segues into the conversation about fracture risk reduction in the old-old cohort, the 80 or 90-something group, which may be best achieved through fall prevention strategies.

Reclast is an intravenous medication used to treat those with osteoporosis. Those who are scheduled to receive Reclast, a once-yearly intravenously administered drug, should have a discussion with their physician to find out if they are considered “at risk”.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229244.htm

The first and most concerning side-effect reported is osetonecrosis of the jaw or (ONJ). This side-effect, however, was seen almost exclusively in those who were using injectable (intravenous) forms of the drugs and/or were being actively treated for cancer. Also worth noting is that most of the rare cases of ONJ, when the oral form of the drug was used, were in those with who had major dental surgery such as a tooth extraction.

These variables are a far cry from the typical user of an oral Fosamax (alendronate) or Actonel in the older adult population. Nevertheless, some people were immediately frightened and stopped taking their medication. Stopping a medication based on information read in the newspaper or found in the lay press is not a safe thing to do.

Osteonecrosis of the jaw is rare in users who take the oral form of these drugs and practicing good oral hygiene reduces the risk of  developing this rare side-effect. The chances of developing ONJ are about 1 in 100,000 for each year of use.  However, if you are going to have a major dental procedure performed, then you should talk with your doctor and dentist to review what are the next appropriate steps.

More recently the side-effect of atrial fibrillation from Fosamax-like drugs was in the newspaper. We received an update from the Food and Drug Administration, and all conclusions show that the risk of this heart rhythm disturbance is very, very small. In fact, the conclusion of these findings is such that we can say, in general, the benefits of the use of these drugs in older adults in preventing fractures greatly outweighs the risk of developing atrial fibrillation.  Nevertheless, general statements don’t always represent all older adults. If you have a history of atrial fibrillation or are at high risk for the condition, it may be prudent to discuss the benefits and the risks with your physician. We have the references on file for you or your physician to view.

Last but not least, there has been some discussion about stopping these bone health drugs if you have been on one for at least 5 years. In the original study in which Fosamax was proven to reduce hip fractures, it was suggested that after 5 years there was no further reduction in hip fractures when compared to placebo. There can be several flaws in drawing a firm conclusion from that limited evidence. First, one study does not form a consensus opinion and more studies would be needed to support such a claim.

Second, bone density did go down in the placebo group, yet they didn’t fracture at a higher rate which can not be explained. Also, we don’t know if after a long period the behaviors changed in study participants and they actually fell less because they were working at fitness and overall fracture prevention, like they should be! Falling wasn’t measured in the Fracture Intervention Trial, or at least it wasn’t reported, but fractures were the measured outcome. Lastly, everyone is different in where they are at with their bone health. These general findings are not always relevant to one self.

For me, if I had osteoporosis, I would take a bone health drug BUT I would also work very hard at fall prevention and risk factor reduction such as minimizing caffeine intake, eating foods rich in calcium and taking vitamin D. In fact, vitamin D deficiency is common in older adults and is shown to correlate with increased falls and fractures. Talk to your doctor about having your vitamin D level checked.

In closing, fracture prevention is not just about taking a prescription medication but the medication can be extremely important in preventing that disabling hip fracture.