Randomized Teriparatide [Human Parathyroid Hormone (PTH) 1–34] Once-Weekly Efficacy Research (TOWER) Trial for Examining the Reduction in New Vertebral Fractures in Subjects with Primary Osteoporosis and High Fracture Risk

• Published in: The journal of clinical endocrinology and metabolism Vol. 97; no. 9; pp. 3097 - 3106
• Main Authors: Nakamura, Toshitaka, Sugimoto, Toshitsugu, Nakano, Tetsuo, Kishimoto, Hideaki, Ito, Masako, Fukunaga, Masao, Hagino, Hiroshi, Sone, Teruki, Yoshikawa, Hideki, Nishizawa, Yoshiki, Fujita, Takuo, Shiraki, Masataka
• Format: Journal Article
• Language: English
• Published: Bethesda, MD Oxford University Press 01.09.2012; Endocrine Society
• Subjects: Aged; Aged, 80 and over; Biological and medical sciences; Bone Density; Bone Density Conservation Agents - administration & dosage; Bone Density Conservation Agents - adverse effects; Bone Density Conservation Agents - therapeutic use; Bone mineral density; Double-Blind Method; Endocrinopathies; Endpoint Determination; Feeding. Feeding behavior; Female; Fractures; Fundamental and applied biological sciences. Psychology; Humans; Injections, Subcutaneous; Japan; Kaplan-Meier Estimate; Male; Medical sciences; Osteoporosis; Osteoporosis - complications; Osteoporosis - diagnostic imaging; Osteoporosis - prevention & control; Parathyroid hormone; Placebos; Radiography; Risk Reduction Behavior; Spinal Fractures - diagnostic imaging; Spinal Fractures - etiology; Spinal Fractures - prevention & control; Spine (lumbar); Spine - diagnostic imaging; Survival Analysis; Teriparatide - administration & dosage; Teriparatide - adverse effects; Teriparatide - therapeutic use; Vertebrae; Vertebrates: anatomy and physiology, studies on body, several organs or systems; Vertebrates: endocrinology; High risk; Antiosteoporotic; Peptide hormone; Diseases of the osteoarticular system; Vertebra; Fracture; Osteoarticular system; Osteoporosis; Osteoforming; Randomization; Reduction; Weekly; Scientific research; Primary; Clinical trial; Nutritional status; Human; Obesity; Nutrition; Nutrition disorder; Metabolic diseases; Trauma; Parathyroid hormone; Endocrinology; Teriparatide
• ISSN: 0021-972X; 1945-7197
• DOI: 10.1210/jc.2011-3479

Context:Weekly teriparatide injection at a dose of 56.5 μg has been shown to increase bone mineral density.Objective:A phase 3 study was conducted to determine the efficacy of once-weekly teriparatide injection for reducing the incidence of vertebral fractures in patients with osteoporosis.Design and Setting:In this randomized, multicenter, double-blind, placebo-controlled trial conducted in Japan, the incidence of morphological vertebral fractures by radiographs was assessed.Patients:Subjects were 578 Japanese patients between the ages of 65 and 95 yr who had prevalent vertebral fracture.Intervention:Subjects were randomly assigned to receive once-weekly sc injections of teriparatide (56.5 μg) or placebo for 72 wk.Main Outcome Measure:The primary endpoint was the incidence of new vertebral fracture.Results:Once-weekly injections of teriparatide reduced the risk of new vertebral fracture with a cumulative incidence of 3.1% in the teriparatide group, compared with 14.5% in the placebo group (P < 0.01), and a relative risk of 0.20 (95% confidence interval, 0.09 to 0.45). At 72 wk, teriparatide administration increased bone mineral density by 6.4, 3.0, and 2.3% at the lumbar spine, the total hip, and the femoral neck, respectively, compared with the placebo (P < 0.01). Adverse events (AE) and the dropout rates by AE were more frequently experienced in the teriparatide group, but AE were generally mild and tolerable.Conclusion:Weekly sc administration of teriparatide at a dose of 56.5 μg may provide another option of anabolic treatments in patients with osteoporosis at higher fracture risk.