Researchers Consider Drug Experiment Successful Despite Clear Evidence of Harm

A drug trial evaluating zoledronic acid versus placebo was done on a group of about 200 elderly women in nursing homes.  The hope was that the drug would alleviate osteoporosis.unnamed

Osteoporosis is caused by lack of several minerals, including calcium, in the bones. This causes them to weaken, eventually to the point of not being able to support the weight their owner places on them. At this point, they start to crush in on themselves. This is called the ‘fracture-threshold’. Bones in this state are also much more likely to break in a fall.

The trial, reported in JAMA Internal Medicine (Journal of the American Medical Association), leads with this: “Eighty-five percent of institutionalized elderly people have osteoporosis and bone fracture rates 8 to 9 times higher than rates observed among community-dwelling elderly people.”

Eight to nine time higher? That is 800% to 900%? And we are going to fix this with drugs? (We already know the drug will do little good, and likely harm—reasons later.) What were these researchers thinking? If these women are experiencing fractures at this rate, something is way wrong beyond medication.  But nowhere in the article or subsequent comments does anyone suggest that maybe someone could take better care of these vulnerable people. This seems appalling to us, and doubly so given the blasé attitude of the article.

Well the researchers did get an increase in Bone Mineral Density. And guess how much? Three percent. That’s completely miniscule. You might suppose that there might be a 3% reduction in fractures too, so that 900% higher number could be brought down to 873%.

But no such luck. The problem is that zoledronic acid has many side effects:

According to Wikipedia: fatigue, anemia, muscle aches, fever, and/or swelling in the feet or legs Flu-like symptoms, and risk of severe renal impairment.

It is amazing they could get anyone to take it at all.

It turns out that even though bone density was increased, the people that were taking zoledronic acid experienced:

  • 25% more fractures
  • 26% more multiple falls
  • 20+% higher mortality

This hardly sounds like a success story. They assured us that, properly interpreted, the multiple fall rate discrepancy was not statistically significant.  They were, however, unable to wave away the other numbers. The researchers had the chutzpa to remark: “Yet osteoporosis therapy remains vastly under-prescribed to such individuals.”

The “individuals” should count their lucky stars! We do not see how the researchers could even continue the trial with such poor results. Yet, advocate further trials is just what they did.

How Bone Works

Bone deteriorates. Cells called osteoclasts remove old, useless bone. Cells called osteoblasts build new bone. (Terminology: clasts tear down, blasts build.)

Almost all of the drugs yet cooked up for osteoporosis block the osteoclasts. So old, useless bone isn’t removed. Unsurprisingly, bone density goes up, though the increase is entirely due to useless bone hanging around. And also unsurprisingly, the bones aren’t any stronger, because new bone isn’t being built.

The above data confirms this perfectly. Bone density went up, but bone strength didn’t.

New Bone Cannot Be Built With PillsSquats

Anybody, any age, can build new bone. The problem is that the osteoblasts, the bone building cells, respond to mechanical/electrical signals. They don’t respond to chemical signals. Drugs are chemical signals, and are never going to work.

When bone needs to be build, it generates an electrical signal. This tells the osteoblasts to build, and they will. Electrical? Sounds crazy, but read on.  Bone consists of minerals—think concrete—and a collagen matrix—think reinforcing steel or rebar. The concrete cracks—weak bone. The collagen frame is then no longer rigid. It wiggles, twists, and turns. Bone is piezoelectric. Does that ring a bell? If something is piezoelectric, movement will cause it to generate an electric field. Microphones use this. The electric field from the collagen movement causes bone building.

Pills won’t do it. But, giving the big bones a workout will, and not only stop osteoporosis in its tracks, it reverses it. This is easy to do. Just stress the big bones: Do three sets of ten squats, and three sets of ten dead-lifts once a week, with whatever weight you can bear, paying attention to form, and osteoporosis will reverse. And don’t think older people cannot do this kind of exercise; so far my oldest woman patient to do such exercises was in her 90’s. Physicians will tell you not to do such exercise for reasons as diverse as spinal stenosis and excessive joint stress; they only see or know the downside to any exercise and rarely know or appreciate the upside.

In the early 2000’s Dr. Mike had a training group wherein 19 people were in serious trouble with bone density below fracture threshold. These people were already experiencing the effects of osteoporosis. The average improvement for this group was 40%. Eight of these people managed to pull themselves above the fracture threshold and are therefore no longer osteoporotic. This is disease cure.

Instead of the 3% bone density improvement reported above, this is more like a 40% improvement. Details on this care available here.

To their credit, the researchers did acknowledge that the trial had a few flies in the ointment: “The clinical importance of nonsignificant increases in fracture and mortality rates in the treatment group needs further study.” Further study? Why not a study ban for this indication?

If I ever end up in a nursing home and someone asks whether I want to participate in such a study the answer is automatically: “NO.”

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