A Novel Drug for a Crippling Disease by Evan L Lipkis MD

Osteoporosis is a condition in which bones become less dense and lose their cross linking. This leads to fragile bones and fractures. Over 8 million women and 2 million men are effected in the US. 

 

Mortality rates are as high as 40% after a hip fracture and osteoporosis causes more deaths than breast, ovarian and uterine cancers combined. 

 

Present drugs which help prevent bone breakdown include bisphosphonates such as alendronate (Fosamax), which is a pill, and zoledronate (Reclast), which is given intravenously. Other types of anti-resorptive agents include raloxifene (Evista) and denosumab (Prolia).

 

Meds that enhance the formation of bone (anabolic therapies). include teriparatide (Forteo) and abaloparatide (Tymlos).

 

 

A novel drug was released called romosozumab (Evenity) which blocks sclerostin, which blocks bone formation. By binding to sclerostin the bone starts making new bone. Additionally it also prevents bone from breaking down. This drug is given for just one year by monthly self-injections. Women who are postmenopausal and high risk for fractures can receive this new treatment.

 

So what are the benefits?

 

—In one study from the NEJM, considerably less fractures occurred after 1 year compared to placebo.

—In the second year both groups received Prolia and the patients that initially received romosozumab had less fractures at the end of 2 years.

—In a second study alendronate (Fosamax) for 2 years was compared to romosozumab followed by alendronate. The romosozumab group had less spine and hip fractures and bone density was higher too.

 

Side effects include joint pain, inflammation of the jaw (very rare), headache and a slightly increased risk for heart disease and stroke seen in 1 study.

Dr’s. Rx:

This drug might be considered if standard first line drugs fail such as Prolia and alendronate. Generally women should be screened at 65 and men at age 70. Risk factors include age, previous fracture, steroid use, blond hair, blue eyes, sedentary lifestyle etc. Calcium and Vitamin D do not prevent fractures in patients who don’t live in nursing homes. In fact calcium tabs may cause kidney stones and coronary disease.


1 comment

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