DNC NEWS:  Changing Treatments for Osteoporosis



Subject:  A review of current treatments for osteoporosis.  A new study supports the use of strontium.

Our suggested treatments for osteoporosis have changed over the years. We continue to use basic mineral supplements Calcium, Magnesium, and vitamin D.  Other things have changed.  Natural progesterone was a common treatment in the early 1990's.  John Lee's study said it would increase bone density and this was very exciting, but it never panned out in clinical practice.  Later studies didn't show the increased bone density that Lee saw.  So we no longer use progesterone for osteoporosis.  We still prescribe a great deal of progesterone, but for other things. The studies about specific forms of calcium have not convinced us that one form is vastly superior.  Although some forms of calcium have been heavily promoted as more effective, especially hydroxyappatite, it appears that the more generic calcium supplements are adequate. We continue to use Ipriflavone, a semi-synthetic isoflavone, for osteoporosis and for a growing number of other conditions as well.  It affects the bones, slowing bone loss in much the same way as estrogen.  We have discovered that in rare individuals it lowers white blood counts and learned to watch for this.

There are two new things which we have added over the last year that we are excited about.  We started prescribing Menatetrenone (Vitamin K-2) and Strontium. 

The research says Vitamin K-2 will either maintain or slightly increase bone density. More important though, it will make bones stronger and cut fracture rates by more than half.  Vitamin K-2 also appears to have a role in treating dysplastic anemia and possibly cancer.

The other supplement we added to our osteoporosis list is strontium.  Strontium has a long history in treating osteoporosis.  It was studied fifty or more years ago with good results but little use. No drug company was interested in either funding research or promoting it.  Apparently since strontium is natural it isn't patentable. This has changed.  A European company combined strontium with a chemical called Ranelate which they hold a patent on, to produce a patented form of strontium called Strontium Ranelate.  With this patent in place, they have funded several large clinical trials.  One was published just a week or two ago in the New England Journal of Medicine.

The results of this Strontium Ranelate trial are very good.  The women taking strontium had about half the fracture risk of women who didn't.  Bone density in the spine increased by 15% in three years of use.
Strontium Ranelate isn't sold in the United States yet.  It will probably show up eventually as a prescription drug.  No evidence is available that this Ranelate form is superior to other forms of strontium.  We have been using strontium citrate which is available from one of our suppliers.

The supplements we suggest change over the years and at times I find this annoying.  It would be nice to have a nutritional cookbook that remains the same.  Unfortunately experience and science leaves us little choice.  Some supplements seem to come and go in popularity like fads.  One day they are touted as miracles, the next day they are forgotten history.  Steering a rationale course between hype and ethical practice can be challenging.  We make the best choices available based on tradition, experience, and current science.  Yet whatever choices we make, we make them in the context of naturopathic medicine.

The general tenets of our practice do not change.  As naturopathic doctors our focus was, is, and always will be to focus on therapies that encourage and allow the natural healing ability of the body to mend illness.  What changes is our knowledge of what will do this, but not our underlying principles or goals.

Here is the abstract of the new strontium study:

The Effects of Strontium Ranelate on the Risk of Vertebral Fracture in
Women with Postmenopausal Osteoporosis. N Engl J Med 2004;350: 459-68.

Abstract

Background: Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption. In a phase 2 clinical trial, strontium ranelate, an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption, has been shown to reduce the risk of vertebral fractures and to increase bone mineral density.

Methods: To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial, we randomly assigned 1649 postmenopausal women with osteoporosis (low bone mineral density) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years. We gave calcium and vitamin D supplements to both groups before and during the study. Vertebral radiographs were obtained annually, and measurements of bone mineral density were performed every six months.

Results: New vertebral fractures occurred in fewer patients in the strontium ranelate group than in the placebo group, with a risk reduction of 49 percent in the first year of treatment and 41 percent during the three-year study period (relative risk, 0.59; 95 percent confidence interval, 0.48 to 0.73). Strontium ranelate increased bone mineral density at month 36 by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck (P<0.001 for both comparisons). There were no significant differences between the groups in the incidence of serious adverse events.

Conclusions: Treatment of postmenopausal osteoporosis with strontium ranelate leads to early and sustained reductions in the risk of vertebral fractures.

Excerpt from text of study: Throughout the study, subjects received daily calcium supplements at lunchtime (up to 1000 mg of elemental calcium, depending on their dietary calcium intake), to maintain a daily calcium intake above 1500 mg, and vitamin D (400 to 800 IU, depending on the base-line serum concentration of 25-hydroxyvitamin D). After a run-in period of 2 to 24 weeks, depending on the severity of the deficiency of calcium and vitamin D, the subjects were randomly assigned to receive 2 g a day of strontium ranelate (two packets a day of a powder that they mixed with water) or placebo powder for 3 years. Subjects were instructed to take the study drug once daily, at bedtime, or twice daily (one packet 30 minutes before breakfast, and one at bedtime). Most subjects (87 percent) chose the once-daily regimen.


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