A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets

Involutional Osteoporosis Clinical Trial

Official title: A Phase II/III Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Oral Administration of NE-58095NF Tablets Versus Once-daily Oral Administration of NE-58095 2.5-mg Tablets for the Treatment of Involutional Osteoporosis

Status Completed

Clinical Trial Summary

The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of oral administration of NE-58095NF(New formulation) tablets for 12 months in patients with involutional osteoporosis. For this study, patients receiving oral NE-58095 2.5-mg tablets once daily for 12 months are set as the control group.

Clinical Trial Description

The primary objective of the present study is to verify the non-inferiority of oral administration of NE-58095NF tablets for 12 months to once-daily oral administration of NE-58095 2.5-mg tablets for 12 months, in terms of efficacy in patients with involutional osteoporosis.

Secondary objectives of the present study are as follows: to compare the safety of oral administration of NE-58095NF tablets for 12 months with the safety of once-daily oral administration of NE-58095 tablets (at 2.5 mg) for 12 months in patients with involutional osteoporosis at time of wakening ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Involutional Osteoporosis
• Osteoporosis

• NCT number: NCT02066376
• Study type: Interventional
• Source: Ajinomoto Pharmaceuticals Co., Ltd.
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2014
• Completion date: November 2015