Claimed effect · Abaloparatide

Does Abaloparatide help with non-vertebral fracture risk?

A
Grade A — established in humansSame RCT · effect size: moderate
Short answerEstablished in humans. Same RCT point the same way: a moderate effect. Non-vertebral fractures 2.7% against 4.7% on placebo — a relative reduction of about 43% in the published analysis. Hip fractures were too few to judge.

What the studies show

Non-vertebral fractures 2.7% against 4.7% on placebo — a relative reduction of about 43% in the published analysis. Hip fractures were too few to judge.

Several well-run randomised trials in people, pointing the same way. You can plan around this. It still says nothing about whether the effect is worth the side effects for you.

  1. 1
    Miller PD, Hattersley G, Riis BJ, et al. Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis: a randomized clinical trial (ACTIVE).JAMA, 2016;316:722–7332,463 women, 18 months; abaloparatide 80 µg vs placebo vs open-label teriparatide. Fracture percentages are in the paper's table, not the abstract.

In context

Abaloparatide is a 34-amino-acid analogue of parathyroid-hormone-related protein, given as a daily injection for osteoporosis at high fracture risk. In the ACTIVE trial, 2,463 postmenopausal women were randomised to abaloparatide, placebo or open-label teriparatide for 18 months; abaloparatide reduced new vertebral and non-vertebral fractures against placebo and caused less hypercalcaemia than teriparatide. Approved in the US since 2017 and the EU since 2022.

Abaloparatide is approved (rx). Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is Abaloparatide proven to help with non-vertebral fracture risk?
Yes, as far as human trials can show it: Same RCT. LYO grades this outcome A.
What studies are behind the grade?
Non-vertebral fractures 2.7% against 4.7% on placebo — a relative reduction of about 43% in the published analysis. Hip fractures were too few to judge.
Is Abaloparatide approved for this?
Abaloparatide is an approved medicine (Approved (Rx)); whether this particular outcome is a licensed indication is stated on the compound page's regulation section.

Other outcomes for Abaloparatide

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