Fracture Risk, BMD Improvement With Abaloparatide Plus Alendronate in Osteoporosis, OA

Osteoporosis. Computer artwork of the trabeculae in the cancellous (spongy) bone tissue affected by osteoporosis. The cancellous tissue fills the interior of the bones and in osteoporosis its density decreases, increasing the brittleness of the bones and the probability of fractures. Osteoporosis usually affects women, above all after the menopause, because their ovaries no longer produce oestrogen hormones which help to maintain bone mass.
In this post hoc analysis, researchers evaluated the efficacy and safety of abaloparatide followed by alendronate vs placebo followed by alendronate in a subgroup of patients with osteoarthritis.

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ATLANTA — Treatment with abaloparatide for 18 months followed by alendronate may lead to a significant reduction in vertebral fracture risk and improvement in bone mineral density (BMD) in postmenopausal women with comorbid osteoarthritis (OA) and osteoporosis, according to research results presented at the 2019 American College of Rheumatology/Association of Rheumatology Professionals (ACR/ARP) Annual Meeting, held November 8 to 13, 2019, in Atlanta, Georgia.

Researchers assessed the data of a subgroup of patients with OA who participated in the ACTIVE phase 3 trial ( Identifier: NCT01343004), which examined the effects of abaloparatide therapy on BMD in postmenopausal women with osteoporosis. Women with OA who then received open-label treatment with alendronate for 24 months as part of the ACTIVExtend study ( Identifier: NCT01657162)  were assessed for efficacy and safety outcomes, including incidence of new vertebral fracture and change in BMD at the total hip, femoral neck, and lumbar spine after a total of 43 months (18 months in the ACTIVE trial, 1 month for reconsent, and 24 months in ACTIVExtend).

Of 395 patients in the ACTIVExtend trial with ongoing OA, 190 received abaloparatide during the ACTIVE study and 205 received placebo. At 43 months, significantly more patients who received placebo/alendronate experienced ≥1 vertebral fracture compared with those who received abaloparatide/alendronate (7.0% vs 1.1%; P =.004). A similar observation was found for other estimated cumulative incidence fracture end points.

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Compared with the placebo/alendronate group, percent change in BMD from baseline was higher for the abaloparatide/alendronate group at the total hip (2.3% vs 6.0%), femoral neck (1.4% vs 4.9%), and lumbar spine (6.7% vs 14.3%) at 43 months.

The most common treatment-emergent adverse events reported during the study were upper respiratory tract infection, arthralgia, worsening OA, and back pain, most of which were more common in the group that received abaloparatide followed by alendronate.

“This post hoc analysis suggests that [abaloparatide/alendronate] was effective in a subgroup of patients with [osteoporosis] and OA, with no new safety signals identified,” the researchers concluded.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Lane N, Weiss R, Mitlak B, Wang Y, Valenzuela G, Deal C. Abaloparatide followed by alendronate on bone mineral density and fracture incidence in postmenopausal women with osteoporosis and osteoarthritis. Presented at: 2019 ACR/ARP Annual Meeting; November 8-13, 2019; Atlanta, GA. Abstract 2220.

This article originally appeared on Rheumatology Advisor