Study to Investigate Adherence of Patients to Clodronate... | NCT01198457

Studies
Study to Investigate Adherence of Patients to Clodronate (Bonefos) Treatment

NCT01198457

Sponsor

Bayer

Status

Completed

Last Update Posted

Sep 7, 2012Estimated

Enrollment

147Actual

Phase

Not provided

Conditions

Breast Neoplasms
Prostatic Neoplasms
Multiple Myeloma
Osteolysis

Interventions

Clodronate (Bonefos, BAY94-8393)

Countries

Czechia

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

ID	Type	Description	Link
BO0910CZ	Other Identifier	Company Internal

Status Module

Record Verification Date

Sep 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

Jan 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jul 29, 2010

First Submission Date that Met QC Criteria

Sep 9, 2010

First Posted Date

Sep 10, 2010Estimated

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

Sep 6, 2012

Last Update Posted Date

Sep 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

147Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Clodronate (Bonefos, BAY94-8393)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clodronate (Bonefos, BAY94-8393)	Drug	Random group of patients in oncology clinic	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adherence to treatment with oral clodronate (PDC, proportion of days covered).		12 months of therapy.

Secondary Outcomes

Measure	Description	Time Frame
Efficacy evaluation of the therapy based on incidence of skeletal events		12 months
Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors
Bone metastases
Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos.
By agreeing to usage of patients diaries and goodwill with accounting of tablets

Exclusion Criteria:

According to SmPC (Summary of Product Characteristics) Bonefos.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Random group of patients in oncology clinic

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D011471	Prostatic Neoplasms
D009101	Multiple Myeloma
D010014	Osteolysis
D010349	Patient Compliance

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004002	Clodronic Acid

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided