Background/Purpose: The Direct Assessment of Nonvertebral Fracture in Community Experience (DANCE) study was an open-label, prospective, observational study that examined occurrence of nonvertebral fragility fractures in osteoporotic men and women treated with teriparatide for ≤2 yr. and followed for up to 2 more yr. in a community based setting. In DANCE, teriparatide decreased the incidence of nonvertebral fragility fractures in patients treated for >6 mo. (6-24 mo.) vs. ≤6 mo. of therapy (2.12% vs. 3.70%, p=0.002). This retrospective analysis assessed the effects of teriparatide in patients who entered DANCE with prior vertebral fractures, including those with previous vertebral augmentation, vs. those without.

Methods: We compared baseline demographics, safety, and teriparatide effectiveness in patients with or without prior vertebral fractures. Patients with previous vertebral fractures included those that did or did not have vertebral augmentation before study enrollment. Incident rates of nonvertebral fracture following 6-24 vs. 0-6 mo. of teriparatide therapy were compared using a Poisson regression model.

Results: Of 4085 patients who received ≥1 dose of teriparatide 20 µg/day, 715 had documented prior vertebral fractures of which 202 had previous vertebral augmentation. Patients with prior vertebral fractures vs. those without were older (mean [SD] age, 71.85 [10.66] vs. 67.07 [11.92] yr., respectively), more likely to have had prior fragility fractures (95.2% vs. 47.8%), had higher L1-L4 T-scores (-2.35 [1.47] vs. -2.50 [1.35]), had more baseline clinical conditions (2.21 [1.58] vs. 1.72 [1.37]), and a higher proportion had comorbid conditions (88.4% vs. 81.6%) (all p-values <0.04). Mean teriparatide exposure was similar for both groups (541.8 [283.1] vs. 542.3 [292.2] days). Bone density in the spine, total hip, and femoral neck increased similarly in patients with or without prior vertebral fracture (all p-values ≥0.06), with similar results in patients who did or did not have vertebral augmentation (all p-values ≥0.08). Compared with the first 6 mo., the incidence of nonvertebral fractures during months 6-24 was 52% lower (absolute difference 3.76%) in patients with and 37% lower (absolute difference 1.08%) in those without prior vertebral fractures. The reduced incidence of nonvertebral fracture over time was statistically consistent in both groups (effect of time by subgroup interaction p=0.38). Reduction in nonvertebral fracture during months 6-24 vs. the first 6 mo. of treatment was 62% lower (absolute difference 4.33%) for patients with prior vertebral augmentation and 41% (absolute difference 1.44%) for those without. Teriparatide was well tolerated.

Conclusion: Patients with prior vertebral fractures were older and had more fragility fractures and comorbid conditions at baseline than patients without previous vertebral fracture. In this post-hoc analysis, teriparatide improved bone density and reduced the incidence of nonvertebral fractures with >6 mo. vs. ≤6 mo. of therapy in osteoporosis patients with and without prior vertebral fracture, including those with prior vertebral augmentation.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/effect-of-teriparatide-in-patients-with-osteoporosis-with-prior-vertebral-fracture/