Endocrinology Metabolism

Abaloparatide

My patient read on the internet that there is a new drug for osteoporosis called abaloparatide. Is it available? What does it do?

Abaloparatide is a new drug being considered by the FDA for the treatment of osteoporosis. Like teriparatide (Forteo), it is an anabolic agent, one that actually builds bone. So, it is very different from the anti-resorptive agents such as bisphosphonates, denosumab, and raloxifene. It is not available yet.

What are the data supporting this new drug, which will likely be expensive?

In a recent 18 month study in about 2500 postmenopausal women with osteoporosis, abaloparatide was compared with placebo and teriparatide. There were significantly fewer vertebral fractures in the abaloparatide group compared to placebo and probably fewer nonvertebral fractures. Abaloparatide increased bone density more than teriparatide and fewer patients became hypercalcemic. So, it is a promising drug for patients at high risk for fracture. The price is not available now, but it will likely be in the range of teriparatide ($2000 to 2500 per month in the U.S., much less in Europe).

Is abaloparatide associated with osteonecrosis of the jaw (ONJ) or atypical femora l fractures (AFF)?

At this point there are no reports of these two side effects in patients on abaloparatide. Abaloparatide likely works through the same receptor as teriparatide, which has been used to treat patients with incomplete AFF. So, it is unlikely that these side effects will happen with abaloparatide, but we will not know the full side effect profile of the drug until many thousand patients use it.

If this is an expensive drug, how will we use it?

Without FDA approval, the optimal regimen cannot be determined at this time. Some experts see sequential therapy as a way to maximize benefits and minimize side effects. It might be possible to give a short course of an anabolic treatment followed by a period of anti-resorptive treatment. At this time, the long term treatment of this chronic disease, osteoporosis, is based on relatively few studies.

What’s the Evidence?/References

Miller, P.D., Hattersley, G, Riis, B.J.. "Effect of abaloparatide vs placebo on new vertebral fractures in postmenopausal women with osteoporosis, a randomized clinical trial". JAMA. vol. 316. 2016. pp. 722-733.

(This is a report of the key trial of abaloparatide, comparing it with both teriparatide and placebo. At the dose used in the study, abaloparatide appeared to increase bone density more than teriparatide. It also had a very dramatic effect on the incidence of new vertebral fractures.)

Black, D. M., Rosen, C.J.. "Clinical practice. Postmenopausal osteoporosis". N Engl J Med. vol. 374. 2016. pp. 254-262.

(This practical article includes the Institute of Medicine recommendations in the context of treating older women with osteoporosis.)

Adler, R.A., El-Hajj Fuleihan, G., Bauer, D.C.. "Managing osteoporosis in patients on long-term bisphosphonate treatment: report of a task force of the American Society for Bone and Mineral Research". J Bone Miner Res. vol. 31. 2016. pp. 16-35.

(This paper provides an approach to long term management of patients with osteoporosis utilizing the most commonly prescribed medications, bisphosphonates. The approach is based on two long term studies, but clinicians will have to use clinical judgement and shared decision making to determine the best long treatment in individual patients at risk for fracture.)
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