Prolia Approved for Treatment of Steroid Induced Osteoporosis

Many individuals that take steroids for chronic inflammatory conditions get osteoporosis; Prolia now FDA approved for Rx

Spine Community News: Corticosteroids (Deltasone, Depo-Medrol, for example) are a mainstay of therapy for a wide variety of medical conditions, including asthma, rheumatoid arthritis, and ulcerative colitis. Many individuals require corticosteroids for extended periods of time at extra-physiologic doses (greater than 7.5 mg per day). While corticosteroids are necessary for a number of illnesses, this hormone is associated with a wide range of side effects including loss of bone mineral density resulting in osteopenia or osteoporosis. Bone loss may start within a few months of starting corticosteroids. Both of these deficiencies of bone density may result in atraumatic fractures.

Denosumab (Prolia) is an antibody against RANK-ligand, a protein that signals osteoclasts (bone disintegrating cells) to turn on. Blocking this signal allows osteoblasts (bone-forming cells) to build bone with less hindrance. The FDA has approved Denosumab for the treatment of osteoporosis that occurs related to growing older. A recent phase 3 trial reported by Amgen has resulted in the FDA approving Denosumab for the treatment of glucocorticoid-induced osteoporosis (GIOP).

In this study of 795 patients receiving glucocorticoid treatment of greater than or equal to 7.5 mg/day of oral prednisone for a duration of 6 months or longer, were treated with Denosumab 60 mg subcutaneously every 6 months or Risedronate 5mg orally daily. Denosumab demonstrated a significantly greater increase in lumbar spine BMD compared to risedronate at one year (3.8% versus 0.8%, respectively).

Denosumab therapy is usually prescribed to older individuals with post-menopausal osteoporosis. The approval of Denosumab for GIOP allows for the use of the antibody for pre-menopausal women and adult men of any age who are at risk because of the prolonged use of corticosteroids.

David Borenstein, MD

Executive Editor