Does Teriparatide Improve Femoral Neck Fracture Healing: Results From A Randomized Placebo-controlled Trial

• DOI: 10.1007/s11999-015-4669-z
• Publication Date: 2016-03-01T15:34:53Z
• Authors: Mohit Bhandari; Ling Jin; Kyoungah See; Russel Burge; Nigel Gilchrist; Richard Witvrouw; Kelly D. Krohn; Margaret R. Warner; Qasim I. Ahmad; Bruce Mitlak
• Keywords: Teriparatide

Background There is a medical need for therapies that improve hip fracture healing. Teriparatide (Forteo®/ Forsteo®, recombinant human parathyroid hormone) bone anabolic drug approved treatment of osteoporosis and glucocorticoid-induced in men postmenopausal women at high risk. Preclinical preliminary clinical data also suggest teriparatide may enhance Questions/purposes We wished to test the hypotheses with versus placebo would femoral neck healing after internal fixation as measured by (1) frequency revision surgery, (2) radiographic healing, (3) other outcomes including pain control, gait speed, safety. Methods initiated two separate, but identically designed, trials meet FDA requirements provide substantial evidence support approval new indication. The prospective, randomized double-blind, placebo-controlled Phase III studies were designed evaluate effect subcutaneous (20 μg/day) 6 months on 24 months. conducted concurrently planned enrollment 1220 patients per trial. However, was stopped owing very slow patient accrual, an priori decision made pool results those statistical analyses before study completion; pooling specified both protocols. Randomization stratified (sliding screw or multiple cancellous screws) type (displaced nondisplaced). An independent Central Adjudication Committee reviewed surgical procedures radiographs. A total 159 (81 placebo, 78 teriparatide). combined program had low power detect originally expected approximately 80% larger difference 12% between groups risk surgery. Results proportion undergoing surgery 12 14% (11 81) group 17% (13 78) group. review excluded these treated from primary analysis. After exclusions, who did not undergo (primary endpoint) different groups, 88% (90% CI, 0.79-0.93) 84% 0.75-0.90; p = 0.743). no differences achieving (75% [61 81] 73% [57 78] teriparatide; odds ratio, 0.89; 90% 0.46-1.72; 0.692) measures control (such during ambulation, 92% [55 62] 91% [52 57] 0.91; 0.25-3.37; 0.681). reporting adverse events 49% [40 45% [35 (p 0.634) 6-month period. Conclusions small sample size limited this study's potential differences, are exploratory. With available, decrease signs compared placebo. event observed consistent safety profile. Functional health outcome help our understanding recovering fractures. Further large controlled required determine Level Evidence II, prospective study.