title: Effect of teriparatide on bone mineral density and biochemical markers in Japanese women with postmenopausal osteoporosis: a 6-month dose-response study.
abstract: The dose-response efficacy and safety with three doses of teriparatide and placebo was assessed, using once-daily subcutaneous injections for 24 weeks, in Japanese postmenopausal women with osteoporosis at high risk of fracture for reasons of preexisting fracture(s), advanced age, and/or low bone mineral density (BMD). In this multicenter, randomized, placebo-controlled study, 159 subjects were randomized and 154 subjects were included for analysis. Teriparatide (10-microg, 20-microg, and 40-microg doses) showed a statistically significant increase with increasing treatment dose as assessed by the percent change of lumbar spine BMD from baseline to endpoint using Williams' test when compared with placebo (P < 0.001). The mean (+/-SD) percent change in lumbar spine, femoral neck, and total hip BMD with the 20-microg dose from baseline to endpoint was 6.40% +/- 4.76%, 1.83% +/- 7.13%, and 1.91% +/- 3.60%, respectively. Rapid and sustained increases in bone formation markers [type I procollagen N-terminal propeptide (PINP), type I procollagen C-terminal propeptide (PICP), and bone-specific alkaline phosphatase (BAP)], followed by late increases in a bone resorption marker [type I collagen cross-linked C-telopeptide (CTX)], were observed for the teriparatide treatment groups (20-microg, 40-microg), suggesting a persistent, positive, balanced anabolic effect of teriparatide. Optimal adherence was achieved by this daily self-injection treatment. Regarding safety, most of the adverse events were mild to moderate in severity. No study drug-or study procedure-related serious adverse events were reported during the treatment period. These results observed in Japanese patients may support the observation that teriparatide stimulates bone formation in patients with osteoporosis at a high risk of fracture.
authors.affiliation: Lilly Research Laboratories Japan, Eli Lilly Japan K.K., Sannomiya Plaza Bldg., 7-1-5 Isogamidori, Chuo-ku, Kobe, 651-0086, Japan. miyauchi_akimitsu@lilly.com
authors.forename: Akimitsu
authors.initials: A
authors.lastname: Miyauchi
authors.forename: Toshio
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Shigeta
authors.forename: Mika
authors.initials: M
authors.lastname: Tsujimoto
authors.forename: Daniel
authors.initials: D
authors.lastname: Thiebaud
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Nakamura
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood*; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000494:pharmacology / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D005269:Femur / Q000000981:diagnostic imaging / Q000187:drug effects; D006615:Hip / Q000000981:diagnostic imaging; D006801:Humans; D007564:Japan; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000187:drug effects; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology*; D010919:Placebos; D011859:Radiography; D019379:Teriparatide / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D010919:Placebos; D019379:Teriparatide