Controlled Study of ONO-5920 in Patients With Involutiona... | NCT00212719

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

NCT00212719

Sponsor

Ono Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Oct 11, 2012Estimated

Enrollment

250

Phase

Phase 3

Conditions

Involutional Osteoporosis

Interventions

ONO-5920

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Apr 2006Actual

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2012

Last Update Posted Date

Oct 11, 2012Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250

Name	Type	Description	Arm Group Labels	Other Names
ONO-5920	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean bone mineral density of the lumbar spine (L2-4 BMD)

Secondary Outcomes

Measure	Description	Time Frame
Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
Other inclusion criteria as specified in the study protocol.

Exclusion Criteria:

Patients having secondary osteoporosis or another condition that presents low bone mass.
Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA
Patients that have been administered bisphosphonate derivatives.
Other exclusion criteria as specified in the study protocol.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Project Leader, ' Development Planning	Ono Pharmaceutical Co., Ltd.	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19264155	Derived	Hagino H, Nishizawa Y, Sone T, Morii H, Taketani Y, Nakamura T, Itabashi A, Mizunuma H, Ohashi Y, Shiraki M, Minamide T, Matsumoto T. A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis. Bone. 2009 Jun;44(6):1078-84. doi: 10.1016/j.bone.2009.02.016. Epub 2009 Mar 2.

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases