A Study of Bonviva (Ibandronate) Once Monthly in Post-Men... | NCT00545207

Studies
A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.

NCT00545207

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Jan 26, 2017Estimated

Enrollment

150Actual

Phase

Phase 3

Conditions

Post-Menopausal Osteopenia

Interventions

ibandronate [Bonviva/Boniva]
Placebo

Countries

France

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

Jan 2017

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

Not provided

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 16, 2007

First Submission Date that Met QC Criteria

Oct 16, 2007

First Posted Date

Oct 17, 2007Estimated

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

Jan 25, 2017

Last Update Posted Date

Jan 26, 2017Estimated

Description Module

Brief Summary

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Detailed Description

Not provided

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

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: ibandronate [Bonviva/Boniva]
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ibandronate [Bonviva/Boniva]	Drug	150mg po monthly for 2 years	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trabecular BV/TV at distal radius of non-dominant arm		12 arms

Secondary Outcomes

Measure	Description	Time Frame
Trabecular BV/TV at distal radius of non-dominant arm		6 months and 2 years
Bone density, trabecular BV/TV at distal tibia		6 months, 1 and 2 years
Serum CTX

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

post-menopausal women, aged 55-75 years;
diagnosed osteopenia.

Exclusion Criteria:

history of osteoporotic vertebral fracture;
contraindication to ibandronate.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
D000077557	Ibandronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Lyon		69437	France