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

Involutional Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212667
• Other study ID #: ONO-5920-02
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 10, 2012
• Start date: August 2002

Study information

• Verified date: October 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT00189891

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Involutional Osteoporosis
• Osteoporosis

Intervention

Drug:
• ONO-5920

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd	Astellas Pharma Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New fragility vertebral fracture
Secondary	New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain