Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1–34)] in postmenopausal osteoporosis

Clinical data suggest concomitant therapy with bisphosphonates and parathyroid hormone (PTH) may blunt the anabolic effect of PTH; rodent models suggest that infrequently administered bisphosphonates may interact differently. To evaluate the effects of combination therapy with an intravenous infusio...

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Bibliographic Details
Published in:Journal of bone and mineral research 2011-03, Vol.26 (3), p.503-511
Main Authors: Cosman, Felicia, Eriksen, Erik Fink, Recknor, Chris, Miller, Paul D, Guañabens, Núria, Kasperk, Christian, Papanastasiou, Philemon, Readie, Aimee, Rao, Hanumantha, Gasser, Jürg A, Bucci‐Rechtweg, Christina, Boonen, Steven
Format: Article
Language:English
Subjects:
Aged
Biological and medical sciences
Biomarkers - metabolism
BISPHOSPHONATE
Bone Density - physiology
Bone Density Conservation Agents - administration & dosage
Bone Density Conservation Agents - adverse effects
Bone Density Conservation Agents - therapeutic use
Bone Remodeling - physiology
Collagen Type I - blood
Diphosphonates - administration & dosage
Diphosphonates - adverse effects
Diphosphonates - therapeutic use
Drug Therapy, Combination
Female
Follow-Up Studies
Fundamental and applied biological sciences. Psychology
Humans
Imidazoles - administration & dosage
Imidazoles - adverse effects
Imidazoles - therapeutic use
INFUSION
Injections, Intravenous
Injections, Subcutaneous
Least-Squares Analysis
Middle Aged
OSTEOPOROSIS
Osteoporosis, Postmenopausal - blood
Osteoporosis, Postmenopausal - complications
Osteoporosis, Postmenopausal - drug therapy
Osteoporosis, Postmenopausal - physiopathology
Osteoporotic Fractures - blood
Osteoporotic Fractures - complications
Osteoporotic Fractures - drug therapy
Osteoporotic Fractures - physiopathology
Peptide Fragments - blood
Peptides - blood
Procollagen - blood
Skeleton and joints
TERIPARATIDE
Teriparatide - administration & dosage
Teriparatide - adverse effects
Teriparatide - therapeutic use
Vertebrates: osteoarticular system, musculoskeletal system
ZOLEDRONIC ACID
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Summary:Clinical data suggest concomitant therapy with bisphosphonates and parathyroid hormone (PTH) may blunt the anabolic effect of PTH; rodent models suggest that infrequently administered bisphosphonates may interact differently. To evaluate the effects of combination therapy with an intravenous infusion of zoledronic acid 5 mg and daily subcutaneous recombinant human (rh)PTH(1–34) (teriparatide) 20 µg versus either agent alone on bone mineral density (BMD) and bone turnover markers, we conducted a 1‐year multicenter, multinational, randomized, partial double‐blinded, controlled trial. 412 postmenopausal women with osteoporosis (mean age 65 ± 9 years) were randomized to a single infusion of zoledronic acid 5 mg plus daily subcutaneous teriparatide 20 µg (n = 137), zoledronic acid alone (n = 137), or teriparatide alone (n = 138). The primary endpoint was percentage increase in lumbar spine BMD (assessed by dual‐energy X‐ray absorptiometry [DXA]) at 52 weeks versus baseline. Secondary endpoints included change in BMD at the spine at earlier time points and at the total hip, trochanter, and femoral neck at all time points. At week 52, lumbar spine BMD had increased 7.5%, 7.0%, and 4.4% in the combination, teriparatide, and zoledronic acid groups, respectively (p 
ISSN:0884-0431
1523-4681
DOI:10.1002/jbmr.238