This article covers a six-year study of 2,000 women in New Zealand ages 65 or older who had a scan indicating osteopenia, or moderate bone loss. Half received up to four infusions of the bisphosphonate zoledronate acid (brand name Reclast), administered in 18 month intervals. The other half received placebo infusions.
The study, published in the New England Journal of Medicine, found that the women who received zoledronate had a lower risk of developing a fracture than those on the placebo. This finding could be used to recommend broader use use of bone-building drugs in people with moderate bone loss.
The story addressed the significance of the findings, the size of the benefit, the quality of the evidence, and conflicts of interest. It also mentioned potential major adverse effects that the study could not rule out. We think the coverage could have been improved by mentioning side effects and alternative strategies for bone health.
Bone breaks and fractures become more common as people age. At age 65, most women receive their first DEXA scan, a test that uses low-dose X-rays to measure the amount of calcium and other minerals inside the bone. The test results score bone as normal thinning (osteopenia) or very thin (osteoporosis).
It is widely recommended that women with osteoporosis make a type of bone-building drug called a bisphosphonate. This study looked at the effects of one bisphosphonate — Reclast — in women with osteopenia, which is believed to be a much larger population.
New stories about studies that might encourage wider use of any medication should include ample information about potential benefits and harms. In this case, bisphosphonates have a fraught history that should inform news coverage.
As this NPR article from 2009 explains, the diagnosis of osteopenia was created in 1992 to describe women with thinning bones based on a scan.
That opened up a new group of potential patients for bisphosphonates, despite little research to show the drugs could prevent fractures and uncertainty about long-term safety.
More recently, growing concerns about the harms of overdiagnosis and overtreatment has shifted the focus to lifestyle changes to improve bone health.
The article states that a generic version of Reclast costs $200 to $500 per infusion, “depending on insurance and other factors.”
The article explains that the study found that 122 women in the group assigned to receive the drug had broken a bone compared to 190 of those in the placebo group, amounting to a 37% lowered fracture risk.
It also explains that the results show 15 women would need to be treated to prevent one woman from getting a fracture.
The story states that the study wasn’t large enough to rule out two rare complications that can occur with bisphosphonates like the one used in this study — deterioration of the jaw and a crack in the thigh bone.
However, we think the story should have also discussed potential side effects. The researchers reported that 62 women declined the second infusion because of side effects — either changes in blood proteins associated with inflammation, known as an acute phase response, or inflammation of the iris, known as irisitis. That compared with five women in the placebo group who declined a second treatment based on an acute phase response. No women in the placebo group had irisitis.
It also would have been nice to see a mention of the history of harmful overtreatment of women with osteopenia and osteoporosis, which continues to be a concern.
The story includes details about the size and scope of the trial and important caveats. For example, the article quotes the doctor who wrote an editorial accompanying the study, pointing out that the findings don’t necessarily apply outside of the group that was studied, which is women 65 and older.
The article does not include specific statistics on how many people in the U.S. have osteopenia or osteoporosis, but it does get across that there are millions with moderate bone loss, the group who would be interested in the findings.
It also describes broken bones as “a scourge of aging” that can land someone in a nursing home, and mentions that the risk is “most common in women after menopause.”
The story included one physician’s view that a patient’s risk should be based on age and previous broken bones, not just the bone mineral density score, which was the criteria for patients enrolling in the study.
The article quotes Ian Reid, MD, the researcher who led the study, Michael Econs, MD, the president of the bone society hosting the meeting, and Clifford Rosen, MD, who wrote an editorial published along with the study. It notes that Reid — who’s quoted saying the study suggests women with osteopenia “may benefit from treatment” — consults for Novartis and other drugmakers.
The article doesn’t explain that women diagnosed with osteopenia are encouraged to make lifestyle changes that can help reduce bone loss. These include not smoking, reducing alcohol consumption, exercise to strengthen bones and muscles, and eating a diet rich in calcium and vitamin D.
The story makes it clear that this treatment is available.
The story mentions a lack of evidence about whether bisphosphonates benefit women with moderate bone loss and says this study’s results “suggest these medicines might help more people than those who get them now and can be used less often, too.”
This study is not based on a news release.