What is the role of abaloparatide (Tymlos) in the treatment of osteoporosis?

Updated: Jan 20, 2021
  • Author: Rachel Elizabeth Whitaker Elam, MD, MSc; Chief Editor: Herbert S Diamond, MD  more...
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Answer

Another PTH analogue, abaloparatide (Tymlos), was approved by the FDA in 2017. Approval was based on results at 18 months from the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial [191] and first 6 months of the ACTIVExtend trial. [192]

In the ACTIVE trial of more than 2000 women, subcutaneous abaloparatide was associated with significant reductions in the relative risk for new vertebral fractures (86% reduction) and nonvertebral fractures (43% reduction) compared with placebo. The absolute risk reductions were 3.6% and 2.0%, respectively. The benefits were evident regardless of age, years since menopause, presence or absence of prior fracture (vertebral or nonvertebral), and BMD at baseline. [191]

In the ACTIVExtend trial, roughly 1100 patients who had completed 18 months of abaloparatide or placebo in ACTIVE received open-label alendronate for up to 24 additional months. Data from the first 6 months of ACTIVExtend showed improved BMD and reduced fracture risk throughout the skeleton. [192]

A study performed by an Austrian group using PTH 1-84 to treat pelvic fractures in postmenopausal women with osteoporosis demonstrated that this anabolic agent has the ability to both increase the rate of union and enhance the speed of the process. In addition to improved fracture healing, treatment with PTH 1-84 was also associated with a significant decrease of pain and improved function over the placebo arm. This clinical study supports the extensive animal data that predicted a clear role for PTH in fracture repair. [193]


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