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FDA Approved Treatments

There are a number of treatments to prevent fractures and reduce bone loss. If you have increased fracture risk, discuss the options carefully with your healthcare provider.

Remember: All medications require adequate calcium, vitamin D and exercise to work best.

Download  a quick guide to osteoporosis medicines

Bisphosphonates are antiresorptive treatments and are used in the prevention and treatment of postmenopausal osteoporosis. They can help prevent fractures in people at moderate or high fracture risk and prevent bone loss for men and women taking steroids like Prednisone. Bisphosphonates work by slowing cells that break down bone (osteoclasts) allowing cells that build bone (osteoblasts) more time to work and reduce the imbalance. Actonel® and Fosamax® have also been approved by the FDA for the treatment of osteoporosis in men. Etidronate (Didronel®) was the first bisphosphonate used clinically in the United States and has been approved for the treatment of Paget’s disease, but not for osteoporosis.

How do I take a bisphosphonate pill?

It is very important to follow the instructions for taking a bisphosphonate because they are difficult to absorb. For maximum effectiveness, follow these instructions:

  • Take the pill first thing in the morning on an empty stomach.
  • Take the pill with a FULL 8 oz. glass of water. Do not use orange juice, coffee or any other beverage to take this medicine.
  • Do not eat food or drink other liquids for at least 30 minutes. Remain sitting or standing up (do not lie down) for 30 minutes after taking the medicine.

What are the bisphosphonate brands?

Listed by FDA approval dates

  • 1977: Didronel® (etidronate)
  • 1996: Fosamax® (alendronate)
  • 1998: Actonel® (risedronate)
  • 2005: Boniva® (ibandronate)
  • 2011: Reclast® (zolendronic acid)
  • 2012: Binosto® (alendronate sodium)

What are the generic bisphosphonates?

Listed by FDA approval dates

  • 2003: Generic Didronel® (etidronate)
  • 2008: Generic Fosamax® (alendronate)
  • 2012: Generic Boniva® (ibandronate)
  • 2013: Generic Reclast® (zolendronic acid)
  • 2014: Generic Actonel® (risedronate)

What are the side effects of bisphosphonates?

There is good long term safety data on the bisphosphonates; but as with any medication, there are also side effects. The most common side effects include muscle aches, joint aches, stomach upset or heartburn.

There are also some rare side effects that have been associated with long term use of bisphosphonates. These include osteonecrosis of the jaw (ONJ) and atypical femur fractures.

Calcitonin is a hormone found in the human body that helps with bone metabolism and calcium regulation. Calcitonin can slow bone loss in the spine and increase spine bone density. Calcitonin may also help reduce the risk of spine fractures or help decrease the pain of these fractures. Calcitonin has not been shown to prevent bone loss or fracture in other parts of the body and is given as a nasal spray or as an injection.

Brand name is Miacalcin®.

Side effects may include a runny nose with the nasal spray or an allergic reaction or other effects with the injectable form.

Denosumab is a monoclonal antibody for the treatment of postmenopausal osteoporosis and is given by injection every six months. Prolia works by decreasing the activity of osteoclasts at the molecular level, helping the bone-building cells increase bone mass. Prolia is recommended for women with osteoporosis and high fracture risk, which includes patients who have had an osteoporotic fracture, have several risk factors, or have not responded to other treatments.

Brand name is Prolia®.

Side effects may include back and muscle pain, pain in the extremities, elevation of  lipids in the blood, and bladder infection.

For years, hormone therapy (HT) was considered a panacea for women adjusting to the changes of menopause and for preventive health. Despite a clear benefit for bone health, HT poses other risks for some women, including heart attack, stroke, breast cancer, and blood clots. Because of these serious risks, HT is no longer being used for the treatment of bone loss or fracture prevention.

The current recommendations for women are to take the lowest HT dose possible for the shortest period of time for symptoms associated with menopause. Your healthcare provider can share the risks and benefits and it is important to review the pros and cons annually. The North American Menopause Society has more information about HT.

HT is administered in several forms including oral or transdermal, gels and lotions including: Premarin®, Estrace®, Ogen®, Cenestin®, Climara®, Vivelle-Dot®, Menostar®, and others.

HT is associated with a slightly increased risk of heart attack, breast cancer, stroke, and blood clots.

Parathyroid Hormone (PTH) is an anabolic treatment for osteoporosis that stimulates new bone growth and reduces fracture risk. PTH is generally reserved for individuals with severe osteoporosis. Studies have demonstrated significant increases in bone mineral density and large decreases in fractures. PTH is a daily injection (like insulin) that is prescribed for 12-24 months. Forteo is approved for men and postmenopausal women with osteoporosis who are at high risk for fractures.

Brand name is Forteo®.

Side effects may include dizziness and leg cramps.

Lilly & Co. patient educational support services (1-866-436-7836).

If you are a commercially insured patient, you can access a co-pay card.

For patients unable to afford the medication, contact the Lilly Cares Foundation Patient Assistance Program or call 1-800-545-6962 to request an application.

The U.S. Food and Drug Administration (FDA) approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are not able to take other osteoporosis medicines.
Evenity, developed by Amgen, is a monoclonal antibody that blocks the effects of the protein sclerostin and works mainly by increasing new bone formation.
One dose of Evenity consists of two injections, one immediately following the other, given once a month by a health care professional. The bone forming effect of Evenity decreases after 12 doses, so the treatment is stopped at the end of a year. To maintain the gains in bone density from Evenity, patients will be prescribed another osteoporosis medicine that reduces bone breakdown.
Common side effects of Evenity included joint pain and headache. Injection site reactions were also observed.

Evenity contains a boxed warning on its labeling stating that it may increase the risk of heart attack, stroke and cardiovascular death.

Patients who have had a heart attack or stroke within the previous year should not use Evenity.

Abaloparatide is a synthetic peptide analog of the human parathyroid hormone-related protein. Like parathyroid hormone, this is an anabolic agent that stimulates new bone growth and reduces the risk of fractures. Clinical trials show a decrease in new vertebral and nonvertebral fractures, an increase bone mineral density, and an increase in a marker of bone formation.

Brand name is Tymlos®.

The most common side effects are high calcium, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.

Radius Health offers a support program www.togetherwithTYMLOS.com or call 1-866-TYMLOS4 (1-866-896-5674) between 8 am and 8 pm EST, Monday through Friday.

Selective Estrogen Receptor Modulator or SERMs, are often called designer estrogens. They are a family of drugs made in a laboratory. SERMs have some effects similar to estrogen on bone, cholesterol and other blood fats. SERMs decrease the effects of estrogen on certain tissues like the breast and uterus, and may be used with people who are at risk for developing these cancers. SERMs may also reduce the risk of breast cancer and lower cholesterol. Research is currently being done to better understand these effects.

The SERM, Evista® (raloxifene), has been approved for the prevention and treatment of osteoporosis. Evista has been shown to help prevent bone loss in the hip and spine and decrease spine fractures and is available as a pill.

The SERM Bazedoxifene has paired with estrogen to create Duavee® and been approved for the prevention of osteoporosis in women who have a uterus. Duane has been sown to decrease spine fractures and is available as a pill.

Side effects may include hot flashes, leg cramps, and blood clots. SERMs normally do not cause bloating, breast tenderness, or bleeding from the uterus.

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What to know about bone health
and fracture prevention during COVID-19

  • Remove fall dangers in your home.
  • Stay physically active, and at least 6 feet away from others.
  • Eat for proper nutrition, and take a supplement if needed to get enough calcium and vitamin D.
  • Stick with your osteoporosis medicines and ask your doctor for extra if you’re unable to go to the pharmacy.
  • If you are due for Reclast, there is little concern about delaying for a few weeks or months.
  • If you take Prolia or Evenity injections, don’t miss your appointment.  Some facilities offer “drive-through” injections. Check with your doctor.
  • Bone density testing can be postponed, if necessary.
  • Speak with your doctor about the possibility of telephone and video visits.

The Centers for Disease Control and Prevention has a page with steps you can take to reduce your risk of catching the virus if you have a chronic illness.

Be well. We are here for you if you have any questions.