Is Miacalcin Nasal Spray Good Enough for Me?

Neil Gonter, MD Health Pro
  • Reader Question: I have been treating my osteoporosis for the past few years with medications.  Recently I developed intolerance to all oral medications.  I am scared to get IV medications and would like to go on Miacalcin nasal spray.  Is this good enough for me? 

     

    Dr. Gonter's Response: There are currently many available treatments for osteoporosis.  Miacalcin nasal spray (generic name: calcitonin) has been on the market longer then almost all of the other available therapies.  However, since then, better medications have been released making the use of this product less necessary.  

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    History of Calcitonin/Miacalcin

     

    The history of calcitonin, as an effective agent for osteoporosis, has been loaded with many irregularities.  In the early 1990's, a few small studies were used to show the efficacy of intranasal administration of salmon calcitonin on bone and calcium metabolism.  There appeared to be a small increase in the bone density as well as fewer fractures in the treatment group.  These studies involved a small amount of people, but using statistical analysis, this was multiplied to apply to a larger group

     

    In 1994, the FDA advisory, after evaluating numerous small trials, such as the one above, advised approval of calcitonin nasal spray as they felt that the potential benefits outweighed the risks.  The approval was, and remains, for "the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopausal."  It also stated in the package insert/labeling "the evidence of efficacy is based on increases in spinal bone mineral density".  This approval was clearly not due to fracture data.

     

    In 2000, nasal calcitonin's landmark study results were released.  The trial showed a 36% reduction of vertebral deformities in the group that received 200IU a day, but no significant effects with the lower or higher dose.  A U.S. National Institutes of Health osteoporosis consensus panel summarized the results of the PROOF trial as follows:  "The absence of a dose response, a 60% dropout rate, and the lack of strong supporting data from BMD [bone mineral density] and markers decrease confidence in the fracture data"[7]

     

     

    In addition, the drug was not able to prove any significant reduction in fractures in areas other than the spine. 

     

    Other agents

     

    A multitude of agents have since been approved for treatment of osteoporosis.  While it is difficult to make clear comparisons of the various studies of each of the available products, most of these have been shown to reduce fractures significantly more than Miacalcin.  It is also important to point out that many of these drugs are effective in both the spine and areas outside the spine, while Miacalcin has only proven effectiveness in the spine. 

     

    Finally, one should be aware that the studies show that Miacalcin shows a minimal increase in bone density, compared to placebo.  While decrease in fractures is the most important endpoint, one must not expect significant changes on follow up bone densities.

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    In summary, Miacalcin was used early in the treatment for osteoporosis, as it was one of the first and only available drugs on the market.  However, the approval of more efficacious agents should make this drug one of last resort.             

     


    [7] NIH Consensus Development Panel. Osteoporosis prevention, diagnosis, and therapy.  JAMA 2001;285:785-95

     

     

Published On: January 29, 2009