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Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis.
Arch Intern Med. 2004 Oct 11; 164(18):2024-30.AI

Abstract

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 microg) 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 microg, 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.

Authors+Show Affiliations

Regional Bone Center, Helen Hayes Hospital, West Haverstraw, NY 10993, USA. Lindsayr@helenhayeshosp.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15477438

Citation

Lindsay, Robert, et al. "Sustained Vertebral Fracture Risk Reduction After Withdrawal of Teriparatide in Postmenopausal Women With Osteoporosis." Archives of Internal Medicine, vol. 164, no. 18, 2004, pp. 2024-30.
Lindsay R, Scheele WH, Neer R, et al. Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis. Arch Intern Med. 2004;164(18):2024-30.
Lindsay, R., Scheele, W. H., Neer, R., Pohl, G., Adami, S., Mautalen, C., Reginster, J. Y., Stepan, J. J., Myers, S. L., & Mitlak, B. H. (2004). Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis. Archives of Internal Medicine, 164(18), 2024-30.
Lindsay R, et al. Sustained Vertebral Fracture Risk Reduction After Withdrawal of Teriparatide in Postmenopausal Women With Osteoporosis. Arch Intern Med. 2004 Oct 11;164(18):2024-30. PubMed PMID: 15477438.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sustained vertebral fracture risk reduction after withdrawal of teriparatide in postmenopausal women with osteoporosis. AU - Lindsay,Robert, AU - Scheele,Wim H, AU - Neer,Robert, AU - Pohl,Gerhardt, AU - Adami,Silvano, AU - Mautalen,Carlos, AU - Reginster,Jean-Yves, AU - Stepan,Jan J, AU - Myers,Stephen L, AU - Mitlak,Bruce H, PY - 2004/10/13/pubmed PY - 2004/12/16/medline PY - 2004/10/13/entrez SP - 2024 EP - 30 JF - Archives of internal medicine JO - Arch Intern Med VL - 164 IS - 18 N2 - 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 microg) 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 microg, 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. SN - 0003-9926 UR - https://www.unboundmedicine.com/medline/citation/15477438/Sustained_vertebral_fracture_risk_reduction_after_withdrawal_of_teriparatide_in_postmenopausal_women_with_osteoporosis_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/archinte.164.18.2024 DB - PRIME DP - Unbound Medicine ER -