search
Back to results

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

Primary Purpose

Involutional Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Minodronic acid hydrate
Sponsored by
Ono Pharmaceutical Co. Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Involutional Osteoporosis focused on measuring ONO-5920, osteoporosis, bisphosphonate

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Patients who was included in study ONO-5920-02 and completed the medication for two years Other inclusion criteria as specified in the study protocol Exclusion Criteria: Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator Patients having secondary osteoporosis or another condition that presents low bone mass Other exclusion criteria as specified in the study protocol

Sites / Locations

  • Chubu Region Facility
  • Chugoku Region Facility
  • Hokkaido Region Facility
  • Hokuriku Region Facility
  • Kanto Region Facility
  • Kinki Region Facility
  • Kyushu Region Facility
  • Shikoku Region Facility
  • Tohoku Region Facility

Outcomes

Primary Outcome Measures

New fragility vertebral fracture

Secondary Outcome Measures

New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), lower back pain.

Full Information

First Posted
September 13, 2005
Last Updated
June 12, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Astellas Pharma Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT00212628
Brief Title
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Official Title
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Astellas Pharma Inc

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Involutional Osteoporosis
Keywords
ONO-5920, osteoporosis, bisphosphonate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
444 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Minodronic acid hydrate
Primary Outcome Measure Information:
Title
New fragility vertebral fracture
Secondary Outcome Measure Information:
Title
New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), lower back pain.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who was included in study ONO-5920-02 and completed the medication for two years Other inclusion criteria as specified in the study protocol Exclusion Criteria: Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator Patients having secondary osteoporosis or another condition that presents low bone mass Other exclusion criteria as specified in the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Project Leader, Development Planning
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Chubu Region Facility
City
Chubu
Country
Japan
Facility Name
Chugoku Region Facility
City
Chugoku
Country
Japan
Facility Name
Hokkaido Region Facility
City
Hokkaido
Country
Japan
Facility Name
Hokuriku Region Facility
City
Hokuriku
Country
Japan
Facility Name
Kanto Region Facility
City
Kanto
Country
Japan
Facility Name
Kinki Region Facility
City
Kinki
Country
Japan
Facility Name
Kyushu Region Facility
City
Kyushu
Country
Japan
Facility Name
Shikoku Region Facility
City
Shikoku Region Facility
Country
Japan
Facility Name
Tohoku Region Facility
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs