In one study, Evenity was compared with a placebo; in the other, it was compared with a bisphosphonate. In both studies, women taking Evenity found themselves with more bones and fewer fractures.
In January, Evenity was examined by an advisory committee of the F.D.A., which voted 18 to 1 for approval – but invited Amgen to do more research to understand possible cardiovascular side effects.
"This is an enormous need for this drug, and with this disease there is an incredible amount of morbidity and mortality," said Dr. Frederick G. Kushner, cardiologist at the Louisiana Heart Clinic and panelist, who voted to approve the drug.
The next step, said Dr. Bockman, is that companies develop pills to block sclerostin, so that patients do not have to make monthly injections.
It may not be easy to convince patients to take the new drug.
Experts predict that it will be offered to patients at higher risk: those who have had a severe fracture or who have taken bisphosphonates and the parathyroid hormone and have not responded or had any serious side effects.
Too often, however, high-risk patients are afraid of taking drugs to prevent fractures. They remember stories of rare patients who took bisphosphonates and had unusual fractures or deterioration of the bones in their jaws.
"They don't remember the good – fractures are prevented," Dr. Shoback said. "They remember something terrible crucial that someone told them."
Also the dr. Bockman has seen these patients, but he hopes he can at least be convinced to try Evenity.
"This is a very important new drug, very large,"He said." And it's something we really need. "