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dc.contributor.authorMinne, Helmut
dc.contributor.authorAudran, Maurice
dc.contributor.authorSimões, Maria E
dc.contributor.authorObermayer-Pietsch, Barbara
dc.contributor.authorSigurðsson, Gunnar
dc.contributor.authorMarín, Fernando
dc.contributor.authorDalsky, Gail P
dc.contributor.authorGroup, Thomas Nickelsen For The Eurofors Study
dc.date.accessioned2010-10-27T09:19:55Z
dc.date.available2010-10-27T09:19:55Z
dc.date.issued2008-10
dc.date.submitted2010-10-27
dc.identifier.citationCurr Med Res Opin. 2008, 24(11):3117-28en
dc.identifier.issn1473-4877
dc.identifier.pmid18838053
dc.identifier.doi10.1185/03007990802466595
dc.identifier.urihttp://hdl.handle.net/2336/113871
dc.descriptionTo access publisher full text version of this article. Please click on the hyperlink in Additional Links fielden
dc.description.abstractOBJECTIVE: Recombinant teriparatide, a bone anabolic agent, is given to treatment-naïve and pre-treated patients with severe osteoporosis, but few data exist comparing the response to teriparatide in these groups. EUROFORS (the EUROpean study of FORSteodouble dagger) enrolled postmenopausal women with established osteoporosis who were either treatment-naïve or had prior antiresorptive (AR) treatment with or without documented inadequate clinical response. The objective of the secondary analysis described here was to evaluate the interim bone mineral density (BMD) response in these groups after one year of open-label teriparatide therapy.RESEARCH DESIGN AND METHODS: Postmenopausal women with established osteoporosis who enrolled in a prospective, randomized, controlled trial received open-label teriparatide 20 mug/day for the first year. With respect to their prior osteoporosis treatment history, they were retrospectively allocated to one of three groups: treatment-naïve (n = 204), prior treatment with an antiresorptive drug (AR-pretreated) (n = 240), or prior antiresorptive treatment with inadequate response (inadequate AR-responders) (n = 421). BMD was measured by dual energy x-ray absorptiometry.RESULTS: Lumbar spine BMD increased from baseline (p < 0.001) in the three groups (mean, 95% CI); treatment-naïve: 8.4% (7.4%, 9.3%); AR-pretreated: 7.1% (6.3%, 7.9%); inadequate AR-responders: 6.2% (5.6%, 6.9%). Total hip BMD increased from baseline in the treatment-naïve (p < 0.001): 1.8% (1.1%, 2.5%) but did not change in the AR-pretreated: 0.4% (-0.2%, 1.1%) or inadequate AR-responders: -0.3% (-0.9%, 0.2%). Treatment-emergent adverse events were similar in the three groups.CONCLUSION: One year of teriparatide significantly (p < 0.001) increased spine BMD in all groups, and total hip BMD in the treatment-naïve group. Because of the limitations of this interim analysis (most importantly, the short duration of treatment and lack of a control group), further study is needed to determine the optimal treatment duration to reach the potential BMD gains at the proximal femur in patients with prior antiresorptive drug use (mostly bisphosphonates).Clinical trial registration: clinicaltrials.gov, nct00191425.
dc.languageENG
dc.language.isoenen
dc.publisherInforma Healthcareen
dc.relation.urlhttp://dx.doi.org/10.1185/03007990802466595en
dc.subject.meshOsteogenesisen
dc.subject.meshBone Densityen
dc.subject.meshTeriparatideen
dc.titleBone density after teriparatide in patients with or without prior antiresorptive treatment: one-year results from the EUROFORS studyen
dc.typeArticleen
dc.identifier.journalCurrent medical research and opinionen
html.description.abstractOBJECTIVE: Recombinant teriparatide, a bone anabolic agent, is given to treatment-naïve and pre-treated patients with severe osteoporosis, but few data exist comparing the response to teriparatide in these groups. EUROFORS (the EUROpean study of FORSteodouble dagger) enrolled postmenopausal women with established osteoporosis who were either treatment-naïve or had prior antiresorptive (AR) treatment with or without documented inadequate clinical response. The objective of the secondary analysis described here was to evaluate the interim bone mineral density (BMD) response in these groups after one year of open-label teriparatide therapy.RESEARCH DESIGN AND METHODS: Postmenopausal women with established osteoporosis who enrolled in a prospective, randomized, controlled trial received open-label teriparatide 20 mug/day for the first year. With respect to their prior osteoporosis treatment history, they were retrospectively allocated to one of three groups: treatment-naïve (n = 204), prior treatment with an antiresorptive drug (AR-pretreated) (n = 240), or prior antiresorptive treatment with inadequate response (inadequate AR-responders) (n = 421). BMD was measured by dual energy x-ray absorptiometry.RESULTS: Lumbar spine BMD increased from baseline (p < 0.001) in the three groups (mean, 95% CI); treatment-naïve: 8.4% (7.4%, 9.3%); AR-pretreated: 7.1% (6.3%, 7.9%); inadequate AR-responders: 6.2% (5.6%, 6.9%). Total hip BMD increased from baseline in the treatment-naïve (p < 0.001): 1.8% (1.1%, 2.5%) but did not change in the AR-pretreated: 0.4% (-0.2%, 1.1%) or inadequate AR-responders: -0.3% (-0.9%, 0.2%). Treatment-emergent adverse events were similar in the three groups.CONCLUSION: One year of teriparatide significantly (p < 0.001) increased spine BMD in all groups, and total hip BMD in the treatment-naïve group. Because of the limitations of this interim analysis (most importantly, the short duration of treatment and lack of a control group), further study is needed to determine the optimal treatment duration to reach the potential BMD gains at the proximal femur in patients with prior antiresorptive drug use (mostly bisphosphonates).Clinical trial registration: clinicaltrials.gov, nct00191425.


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