This release from The Endocrine Society describes the results of one of a series of randomized, double-blind comparative clinical trials of abaloparatide-SC, an investigational drug designed to increase bone mineral density and prevent bone fractures in postmenopausal women who have osteoporosis and who already had suffered one fracture. The study was presented as a poster presentation at the Society’s recent conference. The release helpfully — and carefully — notes early that the research is “industry sponsored.” The release did a good job discussing the study design and results but didn’t address potential cost and harms.
Some health organizations estimate more than 200 million women (and men) worldwide have osteoporosis and that in the United States, 43 million adults are at risk for osteoporosis and that the disease is responsible for about 2 million broken bones each year. Various prescription treatments are on the market designed to increase bone mineral density and either prevent fractures in the first place or reduce the risk of a subsequent one. Exercise, diet and lifestyle also are involved in risk factor prevention and modification, and all of the prescription drugs carry risks for some women of serious side effects, including higher than usual risks for a rare form of bone cancer, kidney stones, weakness, respiratory infections, and dizziness. The costs of some treatments also are high. Thus, any news of additional drug treatments will be of significant interest to millions of women and men.
The release doesn’t include any discussion of the financial burden of the disease or estimated costs of treating it. This is a big market for drug makers and there are plenty of data available. Forteo, a similar drug to abaloparatide-SC, a human parathyroid hormone, is already on the market. It is reasonable to assume that the cost structure will be similar. GoodRx.com notes that a 28 day supply costs about $2,400.
The release would have been much more helpful to the reader if it had included some absolute numbers along with the relative risk reductions. The release notes that of 2,463 osteoporosis patients, ages 49 to 86, the drug increased bone mineral density in the lumbar spine by 9.2%, in the hip 3.4% and in the femoral neck by 2.9% compared to placebo. The release also describes the reduction in vertebral fractures by 86%, and other risk reductions, also in terms of percentages. But what were the actual rates of fractures in each group? That would give readers the best sense of the size of the benefit.
A serious omission, the release is essentially silent about potential harms, which, according to other sources, may include “back pain, arthralgia, upper-respiratory-tract infection, hypercalciuria, and dizziness.” A mid-term post-marketing surveillance study of Forteo (teriparatide), a related drug on the market, observed an association but not causation with osteosarcoma (a rare malignant bone cancer) in people taking the drug. Osteosarcoma had been observed in animal trials of the drug that were dependent on dose and treatment duration.
The release provides a good overview of the randomized, double-blind trial which lasted 18 months and provides demographics of those enrolled in the study. The release also lets readers know that there is at least one other drug similar to the one being studied that is already FDA approved. It does a quick but effective job of distinguishing what might be better about the new drug. (Increased density in the hip region that is greater than the existing compound.) It would have been helpful to note that the trial was conducted in the US, Brazil and Denmark which carry different levels of risk for fracture in post menopausal women, as pointed out in an International Osteoporosis Foundation report.
Statements about the potential value of the drug are reasonable and cautious and there’s no disease mongering here.
The release prominently and early notes that the research is “industry sponsored,” and names the company (Radius Health, Inc.). It also notes that the investigator quoted in the release is a consultant to the company. Kudos!
Because the study was comparative, the release gives some detail about its head-to-head comparison with a current drug on the market. There is another class of drug treatments, namely bisphosphonates, that could have been mentioned.
The release notes that the drug is investigational which signifies it is not yet FDA approved and that the study was a phase 3 study.
The release doesn’t make a explicit claim to novelty but it does note the greater hip bone density benefit and reduced fractures with the new drug compared to the existing drug and placebo. We’ll give them the benefit of the doubt as this is a strong indication of new findings.
There’s no unjustifiable language in use here.
Systematic, Criteria-Driven
NO! NO! NO! @TheHeartOrg - This study was on rabbits, and is at least 2 yrs away from human trials. THAT should be the headline, not "breakthrough". Journalists, pls check this @HealthNewsRevu toolkit when writing about animal studies. https://t.co/QFznfsn4ag https://t.co/L1WIStfV8G
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