Prolia Approved for Osteoporosis

Posted on June 7th, 2010 by

Prolia™ (denosumab) has been approved by the U.S. Food and Drug Administration (FDA) for postmenopausal women with osteoporosis who are at high risk of fractures.[1]

Osteoporosis—a condition characterized by low bone mass and deterioration of bone structure—affects an estimated 10 million Americans over the age of 50. Each year, roughly 1.5 million Americans will experience an osteoporosis-related bone fracture.[2] These fractures commonly involve the wrist, hip, or spine but can affect any part of the body.

Prolia targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Prolia has shown promising results in the management of bone metastases, bone loss due to cancer treatment, and postmenopausal osteoporosis.

An important study of Prolia for osteoporosis involved 7,800 postmenopausal women between the ages of 60 and 91. Half the women received Prolia twice a year for three years, and the other half received placebo. Prolia reduced the risk of vertebral, nonvertebral, and hip fractures.

The most common side effects reported with Prolia included back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcemia (low calcium levels in the blood), serious infections, and dermatologic reactions. The suppression of bone turnover by Prolia may also contribute to rare bone problems such as osteonecrosis of the jaw.


[1] FDA News Release. FDA Approves New Injectable Osteoporosis Treatment for Postmenopausal Women. Available at: Accessed June 2, 2010.

[2] U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General, 2004.


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