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

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

Completed

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Key information

Conditions

Involutional Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
Patients having radiographically confirmed vertebral (T4-L4) fractures
Other inclusion criteria as specified in the study protocol

Exclusion criteria

Patients having secondary osteoporosis or another condition that presents low bone mass
Patients having findings on X-ray that affect evaluation of vertebral fracture
Patients that have been administered bisphosphonate derivatives
Other exclusion criteria as specified in the study protocol

Treatment and study plan

ONO-5920

Drug

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

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Collaborators

Astellas Pharma Inc

Registry information

Important dates

Study start: 2002
Primary completion: 2006
First posted: Sep 21, 2005
Registry last updated: Oct 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed