Newsletters

Summer 2010

New Osteoporosis Treatment Approved

On June 1, 2010, the US Food and Drug Administration (FDA) announced the approval of Prolia (denosumab) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Prolia is the first and only treatment that acts by inhibiting RANK ligand, the principal regulator of osteoclastic bone resorption. Approval of Prolia was based on the results of a large clinical trial (FREEDOM) conducted at research centers throughout the world, including here at New Mexico Clinical Research & Osteoporosis Center. FREEDOM showed that Prolia increased bone density and reduced the risk of vertebral fractures by 68%, hip fractures by 40%, and nonvertebral fractures by 20% in women with postmenopausal osteoporosis.
    
Prolia is administered as a 60 mg subcutaneous injection once every 6 months. The infrequent dosing and convenient method of administration makes this an attractive treatment for many patients, particularly for those with difficulties taking one of the oral bisphosphonates, such as Fosamax, Actonel, or Boniva.

 The safety profile of Prolia is favorable. In FREEDOM, there was no increase in the risk of cancer, infection, cardiovascular disease, delayed fracture healing, or low serum calcium, and there were no cases of osteonecrosis of the jaw and no adverse reactions to the injection of Prolia. There was a slight increase in the risk of some skin problems (eczema, serious cellulitis) in patients taking Prolia, while those taking Prolia had fewer falls and concussions than those on placebo.

Who is the kind of person who should be treated with Prolia? FREEDOM showed that it is good treatment for any postmenopausal woman with osteoporosis. However, many patients now begin treatment with generic Fosamax (alendronate) due to its very low cost. Others may be treated with Actonel, Boniva, or Evista. When those drugs cannot be taken due to other medical problems, or if side effects occur, or there is poor response to therapy, then something else must be used. Until now, the main choices have been injectable (IV) bisphosphonates- Reclast every 12 months or Boniva every 3 months. Both of these are excellent treatments for osteoporosis; both have been used and will continue to be used for many patients with osteoporosis. Prolia now provides another helpful option.       
   
 Prolia should be considered for postmenopausal women who need injectable therapy for osteoporosis.  It is especially attractive for patients with veins that are difficult for inserting an IV catheter and for those who have reasons to avoid bisphosphonate therapy.
    
If you are doing well on your present treatment, there is no reason to change. If you think you might be a candidate for treatment with Prolia, see your healthcare provider for more information.

E. Michael Lewiecki, MD                                    
Lance A. Rudolph, MD

This page update10/04/10