title: Teriparatide in patients with osteoporosis and type 2 diabetes.
abstract: Despite evidence for higher fracture risk, clinical effects of osteoporosis treatments in type 2 diabetes (T2D) are largely unknown. Post hoc analyses of the DANCE observational study compared T2D patients and patients without diabetes to assess the effect of teriparatide, an osteoanabolic therapy on skeletal outcomes and safety. Patients included ambulatory men and women with osteoporosis receiving teriparatide 20μg/day SQ up to 24months followed by observation up to 24months. Main outcome measures included nonvertebral fracture incidence comparing 0-6months with 6+ months of teriparatide, change from baseline in BMD and back pain severity, and serious adverse events. Analyses included 4042 patients; 291 with T2D, 3751 without diabetes. Treatment exposure did not differ by group. For T2D patients, fracture incidence was 3.5 per 100 patient-years during 0-6months treatment, and 1.6 during 6months to treatment end (47% of baseline, 95% CI 12-187%); during similar periods, for patients without diabetes, fracture incidence was 3.2 and 1.8 (57% of baseline, 95% CI 39-83%). As determinants of fracture outcome during teriparatide treatment, diabetes was not a significant factor (P=0.858), treatment duration was significant (P=0.003), and the effect of duration was not significantly different between the groups (interaction P=0.792). Increases in spine and total hip BMD did not differ between groups; increase in femoral neck BMD was greater in T2D patients than in patients without diabetes (+0.34 and +0.004g/cm(2), respectively; P=0.014). Back pain severity decreased in both groups. Teriparatide was well tolerated without new safety findings. In conclusion, during teriparatide treatment, reduction in nonvertebral fracture incidence, increase in BMD, and decrease in back pain were similar in T2D and non-diabetic patients.
authors.affiliation: Department of Epidemiology and Biostatistics, University of California San Francisco, 550 16th Street, Box 0560, San Francisco, CA 94158-2549, USA. Electronic address: aschwartz@psg.ucsf.edu.
authors.forename: Ann V
authors.initials: AV
authors.lastname: Schwartz
authors.affiliation: Eli Lilly Regional Operations, Koelblgasse 8-10 A-1030, Wien, Austria. Electronic address: pavo_imre@lilly.com.
authors.forename: Imre
authors.initials: I
authors.lastname: Pavo
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. Electronic address: alam_jahangir@lilly.com.
authors.forename: Jahangir
authors.initials: J
authors.lastname: Alam
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. Electronic address: disch_damon@lilly.com.
authors.forename: Damon P
authors.initials: DP
authors.lastname: Disch
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. Electronic address: schuster_dara@lilly.com.
authors.forename: Dara
authors.initials: D
authors.lastname: Schuster
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. Electronic address: harris_jennifer_meyer@lilly.com.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Harris
authors.affiliation: Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, USA. Electronic address: krege_john_henry@lilly.com.
authors.forename: John H
authors.initials: JH
authors.lastname: Krege
mesh_terms: D000368:Aged; D001416:Back Pain / Q000150:complications / Q000188:drug therapy; D015519:Bone Density; D015897:Comorbidity; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000188:drug therapy* / Q000503:physiopathology; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D010024:Osteoporosis / Q000150:complications* / Q000188:drug therapy* / Q000503:physiopathology; D058866:Osteoporotic Fractures / Q000453:epidemiology; D019379:Teriparatide / Q000009:adverse effects / Q000627:therapeutic use*; D028761:Withholding Treatment
chemical_list: D019379:Teriparatide
keywords: BMD; Fracture; Observational study; Osteoporosis; Teriparatide; Type 2 diabetes