Prolia Osteoporosis drug by Amgen

Prolia Osteoporosis drug treatment by Amgen was approved by the FDA in June of 2010. The drug is a RANK Ligand inhibitor is taken 60 mg subcutaneous injection administered by a health care professional every six months. Clinically it is known as Denosumab. Since it is taken by injection twice a year - thus eliminating some of the problems of some Osteoporosis medications:

  • Remembering to take medication
  • Potential erosion of the esophagus if a pill touches the side of your throat on its way down

This is not the first Osteoporosis drug that is not in pill form. Currently:

  • Aclasta, which is sold in the United States as Reclast and Zometa can be delivered by infusion.
  • Calcitonin can be administered by injection or by nasal spray>/li>

  • Forteo or Teriparatide comes in a self injection format.

What is different about this drug is that it is the first biologic drug for Osteoporosis. (NOTE: Patients taking other biologic drugs, eg. for Rheumatoid arthritis, may have interactions.)

Also this drug will be sold directly to doctors. So it can be delivered by a physician 'almost like a flu shot' in the office.

Clinical tests;.

Clinical studies of the drug showed that women taking the drug had increased bone density, stronger bones, and a

reduced risk for fractures after three years of treatments.(If you want to review some of the early clinical studies, I put a page on the site about these as soon as Amagen announced that it was under review by the FDA. To read these reports click on Denosumab - Prolia, early studies

Possible side effects

Possible side effects include back and extremity pain, high cholesterol, bladder infection, low blood calcium and skin reactions. Since the cells targeted by Prolia play a role in immunity, the drug "has the potential to affect multiple layers of the immune system," according to the FDA. Also because it blocks the work of osteoclasts some have warned that users could suffer from Osteonecrosis of the jaw...just as with Fosamax and the other bisphosphonates BUT this is not known withany degree of certainty.

A press release from Amgen states:

This drug "is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating Prolia. Hypocalcemia may worsen, especially in patients with severe renal impairment. All patients should be adequately supplemented with calcium and vitamin D.

In the pivotal study, serious infections leading to hospitalizations were reported more frequently in the Prolia-treated patient group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated. . . Patients should be advised to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Endocarditis was reported more frequently in the . . treated patient group. Epidermal and dermal adverse events such as dermatitis, rashes, and eczema have been reported. Discontinuation of Prolia should be considered if severe symptoms develop. . . .

(It) resulted in significant suppression of bone remodeling. The significance of these findings is unknown. The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as osteonecrosis of the jaw (ONJ), atypical fractures, and delayed fracture healing. ONJ has been reported in patients . . . Patients should be monitored for these adverse outcomes. The most common adverse reactions (> 5 percent and more common than placebo) were back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis. Pancreatitis has also been reported ..."

The full press release can be found at Prolia press release from Amgen

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