The headlines have been enthusiastic: “Osteoporosis drug Shows Promise for Fracture Prevention.” NPR ran a story that emphasized the strong evidence supporting zoledronate as a safe drug to prevent fractures. All the excitement resulted because of a new study showing positive outcomes when women received an infusion of Reclast (aka zoledronic acid) every 18 months for six years. But is there a downside to zoledronate? Let’s balance the benefits with the risks.
Bone Strength IS Important!
Do you take your bones for granted? Most of us do, unless we break one. If that happens, we often have to cope with a great deal of pain and inconvenience. If we break a leg or a hip it becomes far worse, especially for older people. The mortality rate after hip fracture ranges from 15 to 25% in the first year (New England Journal of Medicine, Nov. 1, 2007).
That’s why there was a so much excitement within the orthopedic community a few weeks ago. A study from New Zealand reported positive results from an old medication for osteoporosis (New England Journal of Medicine, online Oct. 1, 2018).
Zoledronate (Reclast) To Strengthen Bones:
Researchers recruited 2000 older women who had early signs of bone weakness (osteopenia). Half received placebo injections every 18 months. The other half received an infusion of zoledronate (Reclast) every 18 months. The study lasted six years.
The researchers reported 190 women in the placebo group experienced fragility fractures compared to 122 women receiving zoledronate. That is roughly a 30 percent reduction in fracture risk.
The authors noted that 15 women would need to be treated to prevent one broken bone. That is considered a very good response rate. Some bone specialists have hailed this study as a game changer. Others call it a breakthrough.
What About Side Effects?
The New Zealand trial did not report any serious side effects. But zoledronate can cause adverse reactions. The official prescribing information lists arthritis pain, muscle pain and back pain as relatively common complaints. Other symptoms may include headache, dizziness, high blood pressure, indigestion, nausea and abdominal pain.
There is also an “acute phase reaction” which can occur within the first three days of getting an infusion. Symptoms may include fever, chills, pain and a flu-like illness. The authors report the following information:
“In the zoledronate group, 56 women declined to receive the second infusion owing to an acute phase response after the first infusion, and an additional 6 women did not receive the second infusion owing to iritis. In the placebo group, a second infusion was declined by 5 women because of an acute phase response after the first infusion; there were no cases of iritis.”
Iritis is inflammation of the iris (the colored part of the eye). When this occurs it can impact vision and make people sensitive to light. It is also uncomfortable. Iritis is a known side effect of Reclast.
Some Zoledronate Side Effects:
- Arthritis, muscle pain, muscle spasms, back and shoulder pain, bone pain, headaches
- Fever, chills, fatigue
- Dizziness, vertigo
- Abdominal discomfort, nausea, vomiting, heartburn, constipation
- High blood pressure, kidney problems
Reading a long list of side effects is a mind-numbing exercise. Most people glaze over after two or three symptoms. We agree that it is hard to make sense out of such lists. Here are some real people sharing their own stories about zoledronate infusions.
One reader of this column describes her reaction this way:
“I had a Reclast IV infusion one week ago. One day after the injection I got a fever, chills, flu-like symptoms, nausea and felt terrible! I went back to the doctor’s office and they said it will get better. Yes, after one week the chills, fever, nausea and flu symptoms went away!
“Now I have terrible joint pains. My hands hurt so bad I can barely pick up a cup of coffee. My hips, back, legs, ankles and arms hurt terribly. I hope this also goes away because it is limiting what I can do. I wish I had asked or been told what the side effects of this drug were before I took it!”
Although the New Zealand researchers report no serious side effects, other readers have complained of long-lasting pain.
One woman shared this story:
“After a bone scan my doctor prescribed a Reclast infusion. I was in good health. A couple of days after getting the infusion I could not get out of bed. Within a couple of weeks I began having bad joint and bone aches that I had never had before.
“It has been two years now and I have severe hip pain and joint aches. I never had such symptoms before Reclast. I also have neuropathy in my legs and arms. This drug greatly altered my life.”
Mickie in Kentucky offered this balanced perspective:
“Three years of Reclast infusions reversed me from -2.5 (a measure of osteoporosis), which put me at risk for spontaneous bone structure collapse to normal. Side effects were just about unbearable for the first two weeks following the infusions. I would stand and grip the dresser and scream. The best way to describe the pain is I felt like ground glass was being shoved into my bones. After several weeks the pain diminished from intolerable to horrible bone pain.I was put on very strong pain medication.
“As I began to feel somewhat normal it was time for another infusion. The same screaming pain was upon me again. Was I insane to put myself through this torture? At times I thought I couldn’t stand any more pain. But the alternative was bone structure collapse.
“I was able to start weight bearing exercises. Yes, I did have the third infusion. I still have bone pain and take daily pain medication but my bone density test three weeks ago was normal. The treatment was pure torture. It would be kinder to hospitalize a patient to keep them medicated during the worst of it.
“It saved my life so be prepared to live through hell. Ultimately it worked. I do live with daily bone pain. On a scale of 1 to ten I am about a 3, but it beats a 10. It definitely beats the pain of the two shattered wrists I had before it was discovered my bones were darn near dust.”
It is hard to weigh the clear benefits of zoledronate to prevent fractures against the possible risks of joint and muscle pain. Health professionals must provide complete information on this drug so that women at risk of osteoporosis can make an informed decision.
Share your own experience with Reclast (zoledronate or zoledronic acid) in the comment section below.