NCT00212667

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for phase_3

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

August 1, 2002

Completed
3.1 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
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

4.1 years

First QC Date

September 13, 2005

Last Update Submit

October 10, 2012

Conditions

Involutional Osteoporosis

Keywords

ONO-5920, osteoporosis, bisphosphonate

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 spoine (L2-4 BMD), lower back pain

Interventions

ONO-5920DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
  • Patients having radiographically confirmed vertebral (T4-L4) fractures

You may not qualify if:

  • Patients having secondary osteoporosis or another condition that presents low bone mass
  • Patients having findings on X-ray that affect evaluation of vertebral fracture
  • Patients that have been administered bisphosphonate derivatives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Matsumoto T, Hagino H, Shiraki M, Fukunaga M, Nakano T, Takaoka K, Morii H, Ohashi Y, Nakamura T. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int. 2009 Aug;20(8):1429-37. doi: 10.1007/s00198-008-0816-7. Epub 2008 Dec 20.

    PMID: 19101754DERIVED

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. LtTd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 1, 2002

Primary Completion

September 1, 2006

Last Updated

October 11, 2012

Record last verified: 2012-10