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: NCT00212628
• Other study ID #: ONO-5920-04
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 12, 2012
• Start date: June 2004

Study information

• Verified date: June 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

• NCT00189865

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Involutional Osteoporosis
• Osteoporosis

Intervention

Drug:
• Minodronic acid hydrate

Locations

Country	Name	City	State
Japan	Chubu Region Facility	Chubu
Japan	Chugoku Region Facility	Chugoku
Japan	Hokkaido Region Facility	Hokkaido
Japan	Hokuriku Region Facility	Hokuriku
Japan	Kanto Region Facility	Kanto
Japan	Kinki Region Facility	Kinki
Japan	Kyushu Region Facility	Kyushu
Japan	Shikoku Region Facility	Shikoku Region Facility
Japan	Tohoku Region Facility	Tohoku

Sponsors (2)

Lead Sponsor	Collaborator
Ono Pharmaceutical Co. Ltd	Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

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