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Effects of Teriparatide in Postmenopausal Women with Osteoporosis on Prior Alendronate or Raloxifene: Differences between Stopping and Continuing the Antiresorptive Agent

Helen Hayes Hospital (F.C.), West Haverstraw, New York 10993; Department of Medicine (F.C.), Columbia University College of Physicians and Surgeons, New York, New York 10032; Division of Endocrinology, Metabolism and Nutrition (R.A.W.), Department of Medicine, College of Medicine, Mayo Clinic, Rochester, Minnesota 55905; United Osteoporosis Centers (C.R.), Gainesville, Georgia 30506; Department of Medicine (K.F.M.), College of Medicine, Mayo Clinic, Rochester, Minnesota 55905; and Lilly Research Laboratories (L.X., E.V.G., J.H.K.), Eli Lilly and Company, Indianapolis, Indiana 46285

Address all correspondence and requests for reprints to: Dr. Felicia Cosman, Clinical Research Center, Helen Hayes Hospital, West Haverstraw, New York 10993; or Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York 10032. E-mail: cosmanf{at}helenhayeshosp.org.

Objective: The aim of the study was to assess adding vs. switching to teriparatide 20µg/d in patients on alendronate or raloxifene.

Design: We conducted a randomized, open-label trial.

Patients and Interventions: Postmenopausal women with osteoporosis on alendronate or raloxifene for at least 18 months added teriparatide (Add groups) or switched to teriparatide (Switch groups) for 18 months.

Main Outcome Measures: We measured bone turnover markers (BTM) and bone mineral density (BMD).

Results: In the alendronate stratum, increases in BTM were smaller in the Add vs. Switch group [6-month PINP (64 vs. 401%); bone ALP (15 vs. 71%); βCTX (27 vs. 250%); all P < 0.001]. However, at 6 months, total hip BMD increased more in the Add vs. Switch group (1.4 vs. –0.8%; P = 0.002). In the Add vs. Switch group, 18-month BMD increments were higher in lumbar spine (8.4 vs. 4.8%; P = 0.003) and total hip (3.2 vs. 0.9%; P = 0.02), but not in femoral neck (2.7 vs. 2.3%; P = 0.75). In the raloxifene stratum, increases in BTM were also smaller in the Add vs. Switch group [6-month PINP (131 vs. 259%; P < 0.001), bone ALP (31 vs. 44%; P = 0.035), and βCTX (67 vs. 144%; P = 0.001)]. At 6 months, total hip BMD increase was greater in the Add vs. Switch group (1.8 vs. 0.5%; P = 0.028). At 18 months, increases in lumbar spine (9.2 vs. 8.1%), total hip (2.8 vs. 1.8%), and femoral neck (3.8 vs. 2.2%) were not significantly different between groups.

Conclusions: In women with osteoporosis treated with antiresorptives, greater bone turnover increases were achieved by switching to teriparatide, whereas greater BMD increases were achieved by adding teriparatide.