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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


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Title: 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
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
Issue Date: 1-Sep-2012
Publisher: The Endocrine Society
Citation: The Journal of clinical endocrinology & metabolism, 97(9), pp.3097-3106; 2012
Abstract: 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.
Keywords: abdominal discomfort / aged / article / backache / bone density / constipation / contact dermatitis / controlled study / contusion / diarrhea / dizziness / double blind procedure / drug efficacy / drug response / drug safety / drug withdrawal / eczema / female / fragility fracture / gallbladder cancer / gastritis / headache / heart disease / human / hypercalcemia / Japan / major clinical study / malaise / male / multicenter study / nausea / osteoarthritis / phase 3 clinical trial / primary osteoporosis / priority journal / randomized controlled trial / rhinopharyngitis / risk factor / risk reduction / treatment outcome / upper respiratory tract infection / ureter stone / vertebra fracture / vomiting
URI: http://hdl.handle.net/10069/30518
ISSN: 19457197
DOI: 10.1210/jc.2011-3479
Rights: © 2012 by The Endocrine Society.
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/30518

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