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FDA Approves Abaloparatide to Treat Men with Osteoporosis & a High Risk of Fracture

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During the trial, none of the patients had an adverse reaction with a fatal outcome. Serious adverse reactions were reported by 5.4% of patients who received abaloparatide and 5.1% of patients who received placebo. Adverse reactions that led to patients discontinuing treatment were reported in 6.7% of patients who received abaloparatide and 5.1% of patients who received placebo.

Dizziness was the most common adverse reaction (2%) that led to the discontinuation of the study drug in patients who received abaloparatide. Hypercalcemia occurred in 3% of patients who received abaloparatide and none of the patients who received placebo. The pre-dose serum calcium level was similar to baseline in both groups. More patients treated with abaloparatide who had mild or moderate renal impairment (4%) developed hypercalcemia than those with normal renal function (0%). Overall, the other most common adverse reactions (incidence ≥2%) were injection-site reactions (i.e., 13% erythema, 7% swelling and/or 6% pain), abdominal distension (3%), abdominal pain (3%), arthralgia (7%), bone pain (2%), bruising (3%), diarrhea (3%) and nausea (3%).

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Osteoporosis treatments for men are as important as they are for women because a large percentage of men over the age of 50 years will have an osteoporotic-related fracture. Men generally have higher rates of fracture-related mortality.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

  1. News release: Radius Health’s Tymlos (abaloparatide) receives U.S. FDA approval as a treatment to increase bone density in men with osteoporosis at high risk for fracture. 2022 Dec 20.
  2. New drug application approval letter: Tymlos (abaloparatide) injection. 2017 April 28.
  3. Highlights of prescribing information: Tymlos (abaloparatide) injection for subcutaneous use. U.S. Food & Drug Administration. 19 Dec 2022.
  4. Patients at high risk of fracture. International Osteoporosis Foundation. 2023.
  5. Radius Health Inc. Safety and efficacy of abaloparatide-sc in men with osteoporosis (ATOM; NCT03512262). ClinicalTrials.gov. 2021 Nov 8.

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