Thigh Pain on Fosamax or Prolia: Atypical Fractures
[Answers · Bone, menopause and fertility medicines]

Why do bone medicine labels warn about thigh or groin pain?

From FDA labels, public health agencies and published studies · Reviewed

Short answer: Because it can be an early sign of an unusual thigh bone break. The Fosamax and Prolia labels describe atypical femur fractures that happen with little or no injury, and say patients often had a dull, aching thigh pain for weeks to months before a complete break. The labels say anyone on these medicines with thigh or groin pain should be checked for an incomplete fracture.

What an atypical fracture is

The Fosamax label (section 5.5) describes low-energy or low-trauma fractures of the femoral shaft, the long middle part of the thigh bone, reported during bisphosphonate treatment. They most often happen with minimal or no trauma, and can occur anywhere from just below the hip to just above the knee. Atypical breaks of other bones have also been reported, and they may affect both legs.

The label adds that these fractures can also happen in people with osteoporosis who have never taken a bisphosphonate, and that glucocorticoids such as prednisone may also cause them. The Prolia label (section 5.5) carries a similar warning for denosumab, and says atypical femur fractures in its trial program were seen as early as 2½ years into treatment.

The warning sign

The Fosamax label says patients reported prodromal pain, usually a dull, aching thigh pain, weeks to months before a complete fracture. It says anyone with a history of bisphosphonate use who has thigh or groin pain should be suspected of having an atypical fracture and evaluated to rule out an incomplete femur fracture, and that bone pain elsewhere should be considered too.

The Prolia label says patients should be advised to report new or unusual thigh, hip or groin pain. The Fosamax Medication Guide puts it in plain words: a break in the thigh bone can feel like a new pain in your hip, groin or thigh, and you should call your doctor right away.

What the labels say happens next

Both labels say that a person with an atypical femur fracture should also be checked for signs in the other leg. The Prolia label says pausing treatment should be considered case by case, after weighing benefit and risk; the Fosamax label has similar wording for bisphosphonates. Those decisions belong to the prescriber, especially for Prolia, where the label warns about stopping without a plan; see what happens if you stop Prolia.

The ASBMR task force on long-term bisphosphonate use found that the risk of atypical femur fracture clearly rises with how long the medicine is taken, which is one reason labels ask for treatment to be reviewed over time; see how long you can take a bisphosphonate.

What to note

The labels' point is to get new thigh, hip or groin pain checked. Useful notes: when the pain started, which side, whether it is worse with standing or walking, any steroid use, and how long you have been on the bone medicine. Dose Track keeps the start date and each dose, with a notes field for symptoms.

Read more on Dose Track: Fosamax side effects · Prolia side effects · Actonel side effects · Joint pain

General education drawn from labels, public health agencies and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your medicine are the final word. Questions for other users? Ask in the Dose Track community.

Frequently asked questions

Can Fosamax cause a broken thigh bone?+
The label describes rare atypical thigh bone fractures reported during bisphosphonate treatment, often with little or no injury. It notes they also happen in people with osteoporosis who never took one.
What does an atypical femur fracture feel like before it happens?+
The Fosamax label says patients often had a dull, aching thigh pain for weeks to months before a complete break.
Does Prolia have the same warning?+
Yes. The Prolia label asks patients to report new or unusual thigh, hip or groin pain, and reports atypical femur fractures as early as 2.5 years into treatment in its trials.