FDA Approved Medications

How do osteoporosis medications get FDA approved?

When medications are being tested for osteoporosis, they first have to undergo laboratory testing, then testing in animals, and finally be tested in people. In order for a medication to be approved by the FDA (U.S. Food and Drug Administration), the effectiveness and safety of the medication has to be rigorously tested in randomized placebo-controlled trials, the industry standard for proving that a medication really works.

What does it mean when an osteoporosis medication is FDA approved?

When a medication is FDA-approved for osteoporosis, it means that the medication has been tested and it has been proven that the medication reduces bone loss, may increase bone density, and reduces fracture risk (in at least one site) in a person with osteoporosis.

What FDA medications are approved for Osteoporosis?

FDA approved medications for osteoporosis fall into two classes: antiresorptive and anabolic. Antiresorptive medications prevent bone loss, may increase the density of existing bone, and lower the risk of fractures (broken bones). Anabolic medication builds new bone, increases bone density, and helps reduce the risk of broken bones in individuals at high risk of fracture.

The antiresorptive medications include a class of drugs called bisphosphonates.The bisphosphonate medications include:

  • alendronate (brand names: Fosamax, Fosamax Plus D, or Binosto)
  • risedronate (brand names: Actonel, Actonel with Calcium, and Atelvia )
  • ibandronate ( brand name: Boniva)
  • zoledronic acid (brand name: Reclast)

Other approved antiresorptive medications include:

  • denosumab (brand name: Prolia)
  • estrogen therapy or hormone therapy (brand name: Duavee)
  • raloxifene (brand name: Evista)

At this time the two approved anabolic medications are:

  • teriparatide (brand name: Forteo)
  • abaloparatide (brand name: Tymlos)
  • romosozumab (brand name: Evenity)

All medications for osteoporosis require a prescription from your healthcare provider. When you consult with your healthcare provider, it is important to discuss all of the potential benefits and risks of osteoporosis medication options. Your healthcare provider will help you decide if you need an osteoporosis medication and if so, which osteoporosis medication is best for you.