Dataset Information

Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.

ABSTRACT: A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-?g twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-?g once-weekly regimen of teriparatide, while also improving safety.

Introduction

While a 56.5-?g once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-?g teriparatide can provide comparable efficacy to the 56.5-?g once-weekly regimen while improving safety.

Methods

A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ??65 years at high risk of fractures (n?=?553) were randomly allocated to the 28.2-?g twice-weekly group (n?=?277) or the 56.5-?g once-weekly group (n?=?276). The primary endpoint was the percentage change in lumbar spine (L2-L4) bone mineral density (BMD) at final follow-up.

Results

The percentage changes in lumbar spine (L2-L4) BMD at final follow-up in the 28.2-?g twice-weekly and 56.5-?g once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400-2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (-?1.6%), non-inferiority of the 28.2-?g twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-?g twice-weekly group (39.7% vs 56.2%; p?ConclusionsA 28.2-?g twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-?g once-weekly regimen while improving safety.

Clinical trial registration

JapicCTI-163477 .

SUBMITTER: Sugimoto T

PROVIDER: S-EPMC6811384 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Publications

Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.

Sugimoto T T Shiraki M M Fukunaga M M Kishimoto H H Hagino H H Sone T T Nakano T T Ito M M Yoshikawa H H Minamida T T Tsuruya Y Y Nakamura T T

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA 20190808 11

A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety.<h4>Introduction</h4>While a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment c ...[more]

PMID: 31392401

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Project description:In this randomized, controlled trial, treatment with once-weekly subcutaneous injection of teriparatide for 72 weeks was found to be associated with a significant reduction in the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture.IntroductionTo determine whether the anti-fracture efficacy of teriparatide is superior to that of alendronate, a prospective, randomized, open-label, blinded-endpoint trial was performed.MethodsJapanese women aged at least 75 years were eligible for the study if they had primary osteoporosis and were at high risk of fracture. Patients were randomly assigned in a 1:1 ratio to receive sequential therapy (once-weekly subcutaneous injection of teriparatide 56.5 μg for 72 weeks followed by alendronate for 48 weeks) or monotherapy with alendronate for 120 weeks. The primary endpoint was the incidence of morphometric vertebral fractures at 72 weeks (at the end of teriparatide treatment).ResultsBetween October 2014 and December 2017, 1011 patients (505 in the teriparatide group and 506 in the alendronate group) were enrolled. Of these, 778 patients (351 and 427, respectively) were included in the primary analysis. The incidence of morphometric vertebral fractures was significantly lower in the teriparatide group (56 per 419.9 person-years, annual incidence rate 0.1334) than in the alendronate group (96 per 553.6 person-years, annual incidence rate 0.1734), with a rate ratio of 0.78 (95% confidence interval 0.61 to 0.99, P = 0.04). In both groups, adverse events were most frequently reported in the following system organ classes: infections and infestations, gastrointestinal disorders, and musculoskeletal and connective tissue disorders.ConclusionOnce-weekly subcutaneous injection of teriparatide significantly reduced the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture.Trial registrationjRCTs031180235 and UMIN000015573, March 12, 2019.

Dataset Information

Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.

Introduction

Methods

Results

Clinical trial registration

Publications

Study of twice-weekly injections of Teriparatide by comparing efficacy with once-weekly injections in osteoporosis patients: the TWICE study.

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