title: The safety and effectiveness profile of daily teriparatide in a prospective observational study in Japanese patients with osteoporosis at high risk for fracture: interim report.
abstract: This postmarketing surveillance study assessed the safety and effectiveness of daily teriparatide treatment in patients with osteoporosis in a Japanese clinical setting. In this prospective, multicenter, observational study, patients with osteoporosis at high risk for fracture received subcutaneous injections of teriparatide (20 μg/day) for a maximum of 24 months. For this interim report, data from 1,671 patients were eligible for analysis at the cutoff date. The mean age was 75.3 years; 93% of patients (1,552/1,671 patients) were women. There were 117 adverse drug reactions (ADRs) reported in 101 of 1,671 patients (6.04%); the most common reported ADRs were nausea, dizziness, headache, and palpitations. No clinically significant safety issues were identified, although 5 serious ADRs were reported in 4/1,671 (0.24 %) patients. At 12 months, 71.9% of patients remained on teriparatide treatment. From 1 month, there were rapid increases in the biomarkers of bone formation P1NP and, to a lesser extent, BAP. In contrast, increases in the biomarkers of bone resorption, serum NTX, urinary NTX, and TRACP5b, were smaller. After 12 months of treatment, there was an increase in bone mineral density at the lumbar spine, femoral neck, and total hip, and a decrease in the Visual Analog Scale score for back pain. The incidence of new vertebral and nonvertebral fractures was 1.21% and 3.18%, respectively. In conclusion, the favorable safety profile and effectiveness of teriparatide observed in this population of Japanese patients with osteoporosis were accompanied by relatively high persistence with treatment, which is a key factor in the success of osteoporosis treatment.
authors.affiliation: Medical Science, Lilly Research Laboratories Development Center of Excellence Japan, Eli Lilly Japan K.K., Sannomiya Plaza Bldg, 7-1-5 Isogamidori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan, yamamoto_takanori@lilly.com.
authors.forename: Takanori
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Masanori
authors.initials: M
authors.lastname: Taketsuna
authors.forename: Xiaoyan
authors.initials: X
authors.lastname: Guo
authors.forename: Masayo
authors.initials: M
authors.lastname: Sato
authors.forename: Hideaki
authors.initials: H
authors.lastname: Sowa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood / Q000652:urine; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001862:Bone Resorption / Q000097:blood / Q000188:drug therapy* / Q000652:urine; D005260:Female; D020662:Guanine Nucleotide Exchange Factors / Q000097:blood / Q000652:urine; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000097:blood / Q000188:drug therapy* / Q000652:urine; D010446:Peptide Fragments / Q000097:blood / Q000652:urine; D011347:Procollagen / Q000097:blood / Q000652:urine; D011446:Prospective Studies; D019379:Teriparatide / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D020662:Guanine Nucleotide Exchange Factors; D010446:Peptide Fragments; D011347:Procollagen; C418483:SIL1 protein, human; C047202:procollagen Type I N-terminal peptide; D019379:Teriparatide