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Safety and Efficacy of Teriparatide in Elderly Women with Established Osteoporosis: Bone Anabolic Therapy from a Geriatric Perspective
Philip Matthyssen, MD, Eddy Dejaeger, MD, PhD, Johan Flamaing, MD, Etienne joosten, MD, PhD, Walter Pelemans, MD, PhD, and Steven Boonen, MD, PhD.
Objectives: To assess the safety and efficacy of teriparatide in patients >75 years old, we compared their findings to those of women <75 years old using data from the Fracture Prevention Trial (FPT).
Design: The FPT was a randomized, multicenter, double-blind, placebo-controlled study.
Participants: Post-menopausal women aged 42-86 years were randomized to placebo
(n = 544) or teriparatide 20 ?g (n = 541, hereafter referred as teriparatide) by daily self-injection for a median 19 months. Patients received daily oral supplements of 1000 mg calcium and 400-1200 IU vitamin D. For this analysis, subgroups were defined according to patient age <75 years (n = 841) and ≥75 years (n = 244).
Measurements: We investigated the effects of teriparatide on bone mineral density (BMD) of lumbar spine and femoral neck, the incidence of new vertebral and new nonvertebral fragility fractures, bone turnover markers including bone specific alkaline phosphatase and urinary deoxypyridinoline corrected for creatinine clearance, and safety.
Results: There were no significant treatment-by-age interactions for the bone turnover markers, femoral neck BMD, vertebral fractures, nonvertebral fragility fractures, height loss, hyperuricemia or hypercalcemia. A significant treatment-by-age interaction for lumbar spine BMD (P = .075) was due to an increase in BMD observed in the placebo 75 years old group. There were no treatment-by-age interactions for important treatment-emergent adverse events (TEAEs) including back pain, nausea, leg cramps, and dizziness. We also reviewed the most important TEAEs in those women 80 years of age including 23 patients from the placebo group and 25 patients from the teriparatide group and found no unexpected TEAEs in the patients treated with teriparatide. These results indicate that the clinical effects of teriparatide were consistent in the older and younger women.
Conclusion: The safety and efficacy of teriparatide in postmenopausal women with osteoporosis is not affected by age.
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