Effects of Two Years of Daily Teriparatide Treatment on BMD in Postmenopausal Women With Severe Osteoporosis With and Without Prior Antiresorptive Treatment

Abstract

Previous antiresorptive (AR) treatment may influence the response to teriparatide. We examined BMD response and safety in a subgroup of 503 postmenopausal women with osteoporosis who received teriparatide for 24 mo. Patients were divided into three groups based on their prior AR treatment: treatmentnaïve (n ‫ס‬ 84); pretreated with no evidence of inadequate treatment response (n ‫ס‬ 134); and pretreated showing an inadequate response to AR treatment (n ‫ס‬ 285), which was predefined based on the occurrence of fractures, persistent low BMD, and/or significant BMD loss while on therapy. Changes in BMD from baseline were analyzed using mixed model repeated measures. Lumbar spine BMD increased significantly from baseline at 6, 12, 18, and 24 mo in all three groups. The mean gain in spine BMD over 24 mo was greater in the treatment-naïve group (0.095 g/cm 2 ; 13.1%) than in the AR pretreated (0.074 g/cm 2 ; 10.2%; p < 0.005) and inadequate AR responder (0.071 g/cm 2 ; 9.8%; p < 0.001) groups. The corresponding increases in total hip BMD were 3.8%, 2.3%, and 2.3%, respectively. Early decreases in hip BMD in the inadequate AR responder group were reversed by 18 mo of treatment. Increases in BMD between 18 and 24 mo were highly significant. Nausea (13.3%) and arthralgia (11.7%) were the most commonly reported adverse events. Asymptomatic hypercalcemia was reported in 5.0% of patients. Teriparatide treatment for 24 mo is associated with a significant increase in BMD in patients with and without previous AR use. Prior AR treatment modestly blunted the BMD response to teriparatide. Safety was consistent with current prescribing label information.

Differing effects of PTH 1–34, PTH 1–84, and zoledronic acid on bone microarchitecture and estimated strength in postmenopausal women with osteoporosis: An 18-month open-labeled observational study using HR-pQCT

“…First, a fraction of participants in each treatment group had received prior bisphosphonate treatment, which has been observed to blunt the response to anabolic therapy in the spine and hip. (40,41) There was no consistent pattern to suggest a blunting of the response in BTM, DXA, or HR-pQCT parameters in the case of previous bisphosphonate use in those treated with PTH 1-34 and PTH 1-84 (data not shown). Because the fraction of previous bisphosphonate users in those treated with PTH 1-34 (28%) was (nonsignificantly) lower compared with PTH 1-84 (45%), we cannot, however, exclude that this difference has impacted findings.…”

Antiresorptives overlapping ongoing teriparatide treatment result in additional increases in bone mineral density

“…(17,18,31) The BMD increase in osteoporosis treatment-naïve patients in the European Study of Forsteo (EUROFORS) trial was only slightly greater during TPTD treatment than in those who had been pretreated with a variety of antiresorptive agents. (32,33) Nevertheless, irrespective of such differences between groups treated with various antiresorptive agents, TPTD shows a marked anabolic effect in patients pretreated with various antiresorptives. (27,32,33) In the present study, the ALN combination group consistently demonstrated a greater BMD increase than the TPTD monotherapy group at both the spine and hip regions when measured by DXA, as well as at the trabecular and cortical bone sites when assessed by 3D CT.…”

“…(32,33) Nevertheless, irrespective of such differences between groups treated with various antiresorptive agents, TPTD shows a marked anabolic effect in patients pretreated with various antiresorptives. (27,32,33) In the present study, the ALN combination group consistently demonstrated a greater BMD increase than the TPTD monotherapy group at both the spine and hip regions when measured by DXA, as well as at the trabecular and cortical bone sites when assessed by 3D CT. This greater increase in BMD in the ALN combination group is markedly different from those increases observed in studies in which ALN was combined with PTH(1-84) or TPTD or PTH from the start of therapy.…”

Effects of 1 year of daily teriparatide treatment on iliacal bone mineralization density distribution (BMDD) in postmenopausal osteoporotic women previously treated with alendronate or risedronate

“…(7) Smaller increases in BMD owing to teriparatide for patients treated previously with antiresorptives compared with treatment-naive patients also have been reported in the European Study of Forsteo (EUROFORS). (8) In contrast, a recent study revealed similar changes in bone turnover markers and BMD induced by teriparatide in patients with previous long-term bisphosphonate therapy compared with treatment-naive patients. (9) Apart from the question of whether the effects of teriparatide might be delayed and/or blunted, osteoporotic patients treated long term with bisphosphonates did have increases in bone-formation and -resorption markers when switching from the antiresorptive to teriparatide treatment.…”