Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Ono Pharmaceutical Co. Ltd650 enrolled

Overview

The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

650

Conditions

Involutional Osteoporosis

Interventions

ONO-5920DRUG

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis 2. Patients having radiographically confirmed vertebral (T4-L4) fractures 3. Other inclusion criteria as specified in the study protocol Exclusion Criteria: 1. Patients having secondary osteoporosis or another condition that presents low bone mass 2. Patients having findings on X-ray that affect evaluation of vertebral fracture 3. Patients that have been administered bisphosphonate derivatives 4. Other exclusion criteria as specified in the study protocol

Outcomes

Primary Outcomes

New fragility vertebral fracture

Secondary Outcomes

New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.