Bone microstructure changes due to once-/twice-weekly teriparatide administration: A report of five cases using high-resolution peripheral quantitative computed tomography.

This study was conducted with the aim of presenting cases in which high-resolution peripheral quantitative computed tomography (HR-pQCT) was used to investigate changes in the bone microstructure due to once-weekly/twice-weekly administration of teriparatide (TPTD). Of osteoporosis patients who participated in a non-inferiority trial (TWICE study: once-weekly vs twice-weekly TPTD) with lumbar bone mineral density as the primary endpoint, five cases scanned by HR-pQCT before TPTD administration were analysed. Two cases were given once-weekly TPTD, three were given twice-weekly TPD, and HR-pQCT was repeated after 48 weeks.

Efficacy of once-weekly and twice-weekly injections of teriparatide by patient characteristics: A post hoc analysis of the TWICE study.

Objectives: To assess differences in efficacy of a 28.2-μg teriparatide formulation for twice-weekly use (2/W-TPTD) by patient characteristics.

Methods: A analysis was performed using data from a multicenter, randomized, double-blind, double-dummy, non-inferiority trial (TWICE study) conducted in Japan comparing the efficacies of once-weekly and twice-weekly injections of teriparatide (TPTD).

Twice-weekly teriparatide improves lumbar spine BMD independent of pre-treatment BMD and bone turnover marker levels.

Introduction: There have been no reports of the effects of baseline lumbar spine bone mineral density (LS-BMD) and bone turnover marker levels on the therapeutic effect of a 28.2-μg teriparatide formulation for twice-weekly use (2/W-TPTD).

Materials And Methods: An analysis was performed using data from a double-blind, randomized, non-inferiority trial (TWICE study) conducted with patients who received 2/W-TPTD or a 56.

Association between elcatonin use and cancer risk in Japan: A follow-up study after a randomized, double-blind, placebo-controlled study of once-weekly elcatonin in primary postmenopausal osteoporosis.

Objectives: On July 20, 2012, the European Medicines Agency (EMA) provided a recommendation that limits the long-term use of calcitonin. Based on this recommendation, we investigate the presence or absence of a cancer diagnosis in subjects who participated in the ongoing clinical trial of elcatonin.

Methods: When the EMA gave this recommendation, we were conducting "a 3-year placebo-controlled clinical study for elcatonin" (hereinafter, referred to as "the original study").

Safety and efficacy in actual clinical practice of once-weekly subcutaneous teriparatide for osteoporosis patients with a high fracture risk.

Objectives: To reassess the safety and efficacy of once-weekly teriparatide 56.5 μg in osteoporosis patients with a high fracture risk.

Methods: This postmarketing observational study was conducted at 72 weeks according to the package insert.

Once-weekly teriparatide increases bone mineral density in the distal 1/10 radius, but not in the distal 1/3 radius.

Teriparatide significantly increases bone mineral density (BMD) of the lumbar vertebrae and femur and has a strong effect in reducing the risk of bone fractures. However, few detailed investigations with dual-energy X-ray absorptiometry (DXA) of the effects of teriparatide on the radius have been reported; specifically, there are no reports of the use of once-weekly teriparatide. In this study, the effect of once-weekly teriparatide in increasing BMD was examined in the distal 1/10 of the radius and the distal 1/3 of the radius using a DXA system for the radius.

Effect of combined humanPTH(1-34) and calcitonin treatment in ovariectomized rats.

We examined the combined effects of human parathyroid hormone 1-34 (hPTH) and elcatonin (ECT: a synthetic derivative of eel calcitonin) to prevent loss of bone mass, architecture and strength in ovariectomized (OVX) rats. Fifty-four female rats (aged 13 weeks) were assigned to one of nine groups: Sham (fake surgery performed), OVX, ECT (15 U/kg administered), PTH5, PTH10 and PTH20 (5, 10 or 20 microg/kg administered), and E+PTH5, E+PTH10 and E+PTH20 (15 U/kg of ECT and 5, 10 or 20 microg/kg of hPTH administered). The drug or vehicle was subcutaneously administered three times a week for 12 weeks.

[Therapeutic agents for disorders of bone and calcium metabolism--Parathyroid hormone in weekly subcutaneous injection].

The parathyroid hormone (PTH) that is marketed outside Japan is for daily administration. It has been proven to increase bone mass and prevent fractures, and the effects are very strong. However, data suggest that daily administration of PTH increases bone resorption.