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Fosamax Jaw Part 1: D reduces pain after osteoporosis treatment

Posted on: September 24, 2012   by  John Cannell, MD

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Fosamax jaw (osteonecrosis of the jaw) is the death of bone cells in the upper and/or lower jaw and is a feared but rare complication of drugs called bisphosphonates. Examples include alendronate (Fosamax), pamidronate (Aredia), zoledronate (Zometa), risedronate (Actonel), ibandronate (Boniva), and Zoledronic acid or zoledronate (Zometa, Zomera, Aclasta and Reclast). Physicians use these drugs for multiple reasons, usually to prevent osteoporosis as well as to prevent complications in patients with cancers. Administration of one of them, Zoledronic acid, is by intravenous infusion.

Side effects of bisphosphonates include inflammation such as pain, fatigue, muscle aches, fever, and/or swelling in the feet or legs. Flu-like symptoms are common after the intravenous one (Zoledronic acid). These are inflammatory side effects and they suggest uncontrolled inflammation is the root cause of the side effects of bisphosphonates, perhaps even the cause of osteonecrosis of the jaw.

The management of osteonecrosis of the jaw is a dilemma. No effective treatment exists, although stopping the drug (if clinically possible) may stabilize the disorder and reduce symptoms. Scientists have measured markers of inflammation before and after administration of these drugs, especially the one given once a year for osteoporosis [Zoledronic acid or zoledronate (marketed under the trade names Zometa, Zomera, Aclasta and Reclast)] and found greatly increased inflammation markers after administration of bisphosponates.

Dr. Antonio Catalano and colleagues of the University of Messina in Italy conducted a well-designed randomized controlled trial earlier this year to see if vitamin D reduced the inflammatory side effects of the intravenous bisphosphonate, Zoledronic acid.

Catalano A, Morabito N, Atteritano M, Basile G, Cucinotta D, Lasco A. Vitamin D reduces musculoskeletal pain after infusion of zoledronic Acid for postmenopausal osteoporosis. Calcif Tissue Int. 2012 Apr;90(4):279-85.

The authors studied 60 women, giving 30 women 300,000 IU of vitamin D3 as a single oral dose and 30 women placebo. Five days later the scientists gave all 60 women an intravenous treatment of Zoledronic acid. They also gave all the 60 women 800 IU/day of vitamin D 3 and 1,000 mg/day of calcium for ethical reasons, as previous publications have indicated that low vitamin D levels are associated with side effects of bisphosphonates.

Then, on day seven, two days after getting the bisphosphonate and seven days after half the subjects received 300,000 IU of D3, the researchers measured pain and inflammation in the two groups. The pain was significantly less in the vitamin D group but the inflammation differences were incredible. The most common marker of inflammation (C reactive protein, or CRP) was about .25 on day one in both groups but by day seven, two days after the bisphosphonate, CRP was .58 in the vitamin D group compared to 2.74 in the placebo group, a five-fold difference.

This study does not prove that vitamin D will prevent Fosamax jaw. It proves that vitamin D reduces markers of inflammation in women getting one of the bisphosphonates. However, it is a randomized controlled trial, it is dramatic, and it is the sort of proof critics say is lacking.

1 Response to Fosamax Jaw Part 1: D reduces pain after osteoporosis treatment

  1. Ron Carmichael

    “it is a randomized controlled trial, it is dramatic, and it is the sort of proof critics say is lacking.” and to me, most importantly, it involved researchers devising a methodology to use therapeutic dosages of D in order to actually enable the opportunity for honest evaluation with meaningful conclusions, as well as to note the need for an ethical provision for baseline protection of the test subjects.

    It is interesting to note that normally one associates C-RP test values with the medical process of evaluating inflammation within the circulatory system, eg endothelial cells of the arteries and veins and yet here it’s associated with potential “whole-body” inflammation secondary to the bisphosphonates acting throughout the body. This may actually reveal more about the fundamental mechanism of action for these drugs. Fascinating. I look forward to the next part of this series!

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