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

Ono Pharmaceutical Co. Ltd250 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

250

Conditions

Involutional Osteoporosis

Interventions

ONO-5920DRUG

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis. 2. 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 that affect measurement of lumbar spinal bone mineral density by DXA 3. Patients that have been administered bisphosphonate derivatives. 4. Other exclusion criteria as specified in the study protocol.

Outcomes

Primary Outcomes

Mean bone mineral density of the lumbar spine (L2-4 BMD)

Secondary Outcomes

Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain

Data from ClinicalTrials.gov

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