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: NCT00212719
• Other study ID #: ONO-5920-03
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: October 10, 2012
• Start date: May 2003

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

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 (1)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean bone mineral density of the lumbar spine (L2-4 BMD)
Secondary	Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain