The osteoporosis pipeline is refilled

With bisphosphonates like Boniva coming under increased scrutiny baby boomer women have a right to be concerned. (Hip fracture picture originally from ADAM, found at NIH's Medline.)

Fortunately the osteoporosis pipeline is now re-filling.

Two different approaches are delivering results in Phase II trials, meaning they're each a major study from hitting the market.

1. A cathepsin-k inhibitor called Odanacatib, from Merck, is showing promise for increasing bone mineral density.
2. A monoclonal antibody called Denosumab, from Amgen, cut the risk of fractures up to 68% in a new clinical trial.

The news is not all good. A three year study of Wyeth's Bazedoxifene, described as a selective estrogen receptor modulator, was shown to be no better than a placebo in a study with 7,500 women. Wyeth sells this as Viviant.

All this shows both the risks and rewards of present drug research. If you can keep baby boomers from fracturing their hips over the next 30 years you can make a mint. But there are many ways to do it, and many ways to fail.

The problem with bisphosphonates is that while they may stop fractures from happening across the bone, they may also enable fractures that run along the bone. The key word in the sentence above is may. We are not yet certain.

But these drugs do seem to be better than nothing. A conservative treatment regimen might cause Boniva, Fosamax and their brethren to be prescribed for years to come.

These other drugs coming down the pipeline work in several different ways, which means there are several different ways in which they might cause side-effects or problems. Patients will have to be matched with drugs carefully.

But that patient-matching may have to be done blindly, in the "let's try this" method doctors are presently forced to use. That's because there are no longitudinal studies available on these drugs, and no genetic markers we can look for in patients.

What's most dangerous is that difficult questions like this are headed for the market, to be discussed in pretty ads which tell you to "see your doctor." Your doctor, meanwhile, may be getting their information from salesmen with pretty brochures.

A lot of research is needed here before we can say anything other than caveat emptor -- let the buyer beware. (This means you, grandma.)