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

Ono Pharmaceutical Co. Ltd444 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

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

444

Conditions

Involutional Osteoporosis

Interventions

Minodronic acid hydrateDRUG

Eligibility

Sex: FEMALEMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who was included in study ONO-5920-02 and completed the medication for two years 2. Other inclusion criteria as specified in the study protocol Exclusion Criteria: 1. Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator 2. Patients having secondary osteoporosis or another condition that presents low bone mass 3. Other exclusion criteria as specified in the study protocol

Locations (9)

Chugoku Region Facility

Chugoku, Japan

Chubu Region Facility

Chūbu, Japan

Hokkaido Region Facility

Hokkaido, Japan

Hokuriku Region Facility

Hokuriku, Japan

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 spine (L2-4 BMD), lower back pain.

Data from ClinicalTrials.gov

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