As baby boomers age, interest in osteoporosis and bone loss treatments is increasing. Women (and some men) taking bisphosphonates received a scare in March, when major news outlets reported links between these drugs and hip fractures. University of Missouri (Kansas City), School of Pharmacy Professor, researcher and author Jack Fincham discussed these issues with Suite 101.
Bone Basics
Like it or not, everyone is aging, and the body changes over time. The body constantly creates and destroys bone. This is normal. Aging, however, spurred on in women by the loss of estrogen in menopause, changes the balance in the two sides of this scale, as bone is destroyed faster than it is created.
As the term osteoporosis suggests, bones become porous, like honeycombs with empty spaces where bone should be. This makes them brittle and subject to fracture. Hip fractures in the elderly often lead to hospitalization, pneumonia and death, Fincham explains.
Reports of Hip Fractures
Sudden hip fractures have occurred in women taking Fosamax. Though rare, these reports are alarming. After all, the drugs are supposed to help prevent fractures not cause them. Fincham explains that, when a medication seems to be causing the problem it was designed to prevent, researchers must consider "patient noncompliance." Bisphosphonates are difficult drugs to take. Patients must be fasting and cannot bend over, lie down or eat for half an hour. If patients weren't taking the drugs as prescribed, that could be a factor.
"This does not seem to be the case, however," Fincham states.
There are warning signs. Women who have had these catastrophic fractures have had bone, muscle and or joint pain as a reaction to the medication. This can start soon after treatment begins or not happen for years.
"There are instances of patients who discontinued the medication," says Fincham, who obtained his Ph.D. in Social and Administrative Pharmacy at the University of Minnesota, "and the pain went away. Some have gone back on the drugs after a rest and the pains have returned, so we know it is the medication causing the problem in these cases."
Why Didn't Anyone Know?
The goal of treating osteoporosis is to stop bone loss. Either the rate at which bone is broken down must be slowed or the rate at which it is built must be increased. The class of drugs known as bisphosphonates (including Fosamax, Actonel and Boniva,) work by inhibiting osteoclasts, slowing down the rate at which bone is destroyed.
Bisphosphonates have been shown to improve bone density as measured by bone density scans. The more important measure from the patient's perspective, however, is whether or not this clinical improvement actually reduces the risk of fracture. Again, studies show that it does.
The issues of hip fracture and bone, muscle and/or joint pain did not and could not have come up in clinical trials, because they involve what happens down the road. The process through which researchers are now learning about these adverse effects is known as "post marketing surveillance," Jack Fincham's specialty.
A Different Kind of Researcher
Jack Fincham doesn't do research in a laboratory. He deals with outcomes of drug therapies. He has written many books, including Taking Your Medicine: A Guide to Medication Regimens and Compliance for Patients and Caregivers (The Haworth Press, 2005), Everyday Guide to Managing Your Medicines (Jones and Bartlett Publishers, 2007) and e-Prescribing: The Electronic Transformation of Medicine (Jones and Bartlett Publishers, 2009). Fincham, who earned a Post-Graduate Certificate Degree in Health Economics at the University of Aberdeen (Scotland), served on the U.S. FDA's Non-prescription Drug Advisory Committee (2003-2008).
Fincham grew up in north central Kansas. He enjoys trying to help people and says, "I've been very fortunate and feel blessed in that capacity."
Osteoporosis, Fosamax and Difficult Choices
According to Fincham, several factors make dealing with bone loss drugs complicated. First, many patients have bone, muscle and/or joint pain prior to taking bisphosphonates. The symptoms go away and then return. The patients don't see the medication as the cause. People also have different levels of pain sensitivity. Additionally, they may see the return of symptoms as their fault.
"They don't need to blame themselves," Fincham states, "They have enough problems without adding guilt."
Making the decision to stop taking Fosamax or to continue taking it despite the pain and risk of hip fracture is a tough one. If the patient is at greater risk for fractures caused by the medication, does that risk trump the risk of fracture without the drugs? If a patient is still losing bone density despite being on the drug, is it because the drug isn't working, or would the rate of loss be even greater without it?
Recommendations for Fosamax Users
Fincham recommends that anyone taking bisphosphonates who experiences bone, muscle and/or joint pain, skin rash, itching, swelling of the face, lips or tongue, heartburn, pain swallowing, black stool, chest pain or jaw pain (especially after dental work) should talk to their doctor about discontinuing the drug.
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