Sequential Treatment of Severe Postmenopausal Osteoporosis After Teriparatide: Final Results of the Randomized, Controlled European Study of Forsteo (EUROFORS)
Sequential Treatment of Severe Postmenopausal Osteoporosis After Teriparatide: Final Results of the Randomized, Controlled European Study of Forsteo (EUROFORS)
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DOI：
10.1359/jbmr.081215
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发表时间：
2009-04-01
影响因子：
6.2
通讯作者：
Glueer, Claus C.
中科院分区：
文献类型：
--
作者：
Eastell, Richard;Nickelsen, Thomas;Glueer, Claus C.
目前尚不清楚在停止特立帕肽治疗严重骨质疏松症后应给予何种治疗。在一项前瞻性、随机、对照、2年的研究中，我们比较了特立哌利1年后3种随访治疗（特立哌利合成代谢、雷洛昔芬抗吸收或无活性治疗）的BMD效应和临床安全性。患有骨质疏松症和近期脆性骨折的绝经后女性接受开放标签的特立帕鲁肽（20 μ g/d）治疗12个月，然后随机（3：1：1）继续特立帕鲁肽（n=305），转换为雷洛昔芬60 mg/d（n=100），或在第二年不接受活性治疗（n=102）。所有患者均接受钙和维生素D补充治疗。使用混合模型重复测量分析从基线到24个月的区域BMD变化。每日特立帕汀治疗2年，脊柱BMD显著增加10.7%。第2年接受雷洛昔芬治疗的患者的脊柱BMD与第1年相比没有进一步变化（较基线变化，7.9%），而未接受活性药物治疗的患者的BMD在第2年下降2.5%（较基线变化，+3.8%）。在全髋关节，2年时，特立哌酮组BMD较基线增加2.5%，雷洛昔芬组增加2.3%，无活性治疗组增加0.5%：股骨颈的变化分别为3.5%、3.1%和1.3%。该研究没有足够的把握度来评估抗骨折疗效。总之，重度骨质疏松症妇女的BMD在特立哌酮治疗2年后逐渐增加。特立帕鲁肽停药后，雷洛昔芬可维持脊柱BMD并增加髋关节BMD。
It is unclear which treatment should be given after stopping teriparatide therapy for severe osteoporosis. In a prospective, randomized, controlled, 2-yr study, we compared BMD effects and clinical safety of three follow-up treatments (anabolic with teriparatide, antiresorptive with raloxifene, or no active treatment) after 1 yr of teriparatide. Postmenopausal women with osteoporosis and a recent fragility fracture received open-label teriparatide (20 mu g/d) for 12 mo before they were randomized (3:1:1) to continue teriparatide (n=305), switch to raloxifene 60 mg/d (n=100), or receive no active treatment for the second year (n=102). All patients received calciurn and vitamin D supplementation. Changes in areal BMD from baseline to 24 mo were analyzed using mixed-model repeated measures. Daily teriparatide treatment for 2 yr significantly increased spine BMD by 10.7%. Patients receiving raloxifene in year 2 had no further change in spine BMD from year 1 (change from baseline, 7.9%), whereas patients receiving no active treatment had a BMD decrease of 2.5% in year 2 (change from baseline, +3.8%). At the total hip, BMD increases from baseline at 2 yr were 2.5% with teriparatide, 2.3% with raloxifene, and 0.5% with no active treatment: the respective changes at the femoral neck were 3.5%, 3.1 %, and 1.3%. The study had insufficient power to assess antifracture efficacy. In conclusion, BMD increases progressively over 2 yr of teriparatide therapy in women with severe osteoporosis. After discontinuation of teriparatide, raloxifene maintains spine BMD and increases hip BMD.