NCT00212628

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

First QC Date

September 13, 2005

Last Update Submit

June 12, 2012

Conditions

Involutional Osteoporosis

Keywords

ONO-5920osteoporosisbisphosphonate

Outcome Measures

Primary Outcomes (1)

  • New fragility vertebral fracture

Secondary Outcomes (1)

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

Interventions

Minodronic acid hydrateDRUG

Eligibility Criteria

Age55 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who was included in study ONO-5920-02 and completed the medication for two years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chugoku Region Facility

Chugoku, Japan

Location

Chubu Region Facility

Chūbu, Japan

Location

Hokkaido Region Facility

Hokkaido, Japan

Location

Hokuriku Region Facility

Hokuriku, Japan

Location

Kanto Region Facility

Kanto, Japan

Location

Kinki Region Facility

Kinki, Japan

Location

Kyushu Region Facility

Kyushu, Japan

Location

Shikoku Region Facility

Shikoku Region Facility, Japan

Location

Tohoku Region Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

YM 529

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Project Leader, Development Planning

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2004

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

JP(9)