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Sustained Vertebral Fracture Risk Reduction After Withdrawal of Teriparatide in Postmenopausal Women With Osteoporosis
Robert Lindsay, MBChB, PhD;
Wim H. Scheele, MD;
Robert Neer, MD;
Gerhardt Pohl, PhD;
Silvano Adami, MD;
Carlos Mautalen, MD;
Jean-Yves Reginster, MD, PhD;
Jan J. Stepan, MD, DSc;
Stephen L. Myers, MD;
Bruce H. Mitlak, MD
Arch Intern Med. 2004;164:2024-2030.
Background Teriparatide (recombinant human parathyroid hormone [1-34]) reduces fracture risk in postmenopausal women with osteoporosis. We assessed the safety and incidence of new vertebral fractures after withdrawal of teriparatide.
Methods This study is a follow-up to the Fracture Prevention Trial (FPT), a randomized, placebo-controlled study of postmenopausal women with osteoporosis treated with teriparatide (20 or 40 µg) once daily for a mean of 18 months. More than 90% of the women remaining at the end of the FPT continued into the follow-up study (n = 1262). Patients and investigators were unblinded to original treatment group assignment. Women were treated according to standard clinical practice, including elective use of osteoporosis drugs. New vertebral fractures were determined by semiquantitative scoring of lateral thoracic lumbar spine radiographs 18 months after the end of the FPT.
Results During the follow-up study, the reduction in fracture risk associated with previous treatment with teriparatide, 20 and 40 µg, was 41% (P = .004) and 45% (P = .001), respectively, vs placebo. The absolute reduction from the FPT baseline to the 18-month follow-up visit was 13% for both doses. Osteoporosis drugs were used by 47% of women during follow-up, with greater use in the former placebo group (P = .04); nevertheless, persistent fracture protection of previous teriparatide therapy was evident. Post hoc analysis also suggests that teriparatide treatment substantially reduced the increased risk of subsequent fracture in women who sustained a fracture during the FPT (P = .05).
Conclusion Vertebral fracture risk reduction by teriparatide administration persists for at least 18 months after discontinuation of therapy.
From the Regional Bone Center, Helen Hayes Hospital, West Haverstraw, NY (Dr Lindsay); Lilly Research Laboratories, Eli Lilly and Co, Indianapolis, Ind (Drs Scheele, Pohl, Myers, and Mitlak); Endocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dr Neer); Rheumatologic Unit, University of Verona, Valeggio sul Minicio, Italy (Dr Adami); the División Osteopatías Médicas, Hospital de Clínicas, Universidad de Buenos Aires, Buenos Aires, Argentina (Dr Mautalen); Department of Public Health, University of Liège, Liège, Belgium (Dr Reginster); and Department of Internal Medicine, Charles University, Prague, Czech Republic (Dr Stepan). Dr Scheele is now with the Women's Health and Bone Department, Wyeth Research, Cambridge, Mass.
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