Awareness to Osteopenia's Treatment by Bisphosphonate in... | NCT00816452

Studies
Awareness to Osteopenia's Treatment by Bisphosphonate in Male Suffering From Prostate Cancer

NCT00816452

Sponsor

Sanofi

Status

Completed

Last Update Posted

Nov 3, 2010Estimated

Enrollment

180Actual

Phase

Not provided

Conditions

Osteoporosis
Prostate Cancer

Interventions

Not provided

Countries

Israel

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

Nov 2010

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

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Dec 31, 2008

First Submission Date that Met QC Criteria

Dec 31, 2008

First Posted Date

Jan 1, 2009Estimated

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

Nov 2, 2010

Last Update Posted Date

Nov 3, 2010Estimated

Description Module

Brief Summary

Patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician.

Primary Objective: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.

Secondary objectives:

To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.

To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.

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

180Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.		6 months

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.		6 months
To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Man with Prostate Cancer
Men ≥70 years old or ≥60 years old treated by LH-RH agonist for at least 2 years or Man who was diagnosed in the past with Osteopenia/osteoporosis
Osteopenia/osteoporosis proven by bone density test.

Exclusion Criteria:

Creatinine clearance < 30ml/min
Hypercalcemia
Actual treatment by Bisphosphonate or steroids
Hypersensibility to Bisphosphonate or any contraindication to its use.
Metastatic prostate Cancer
Patients not suitable for compliance.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Male with Prostate Cancer suffering from Osteoporosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nurit Tweezer	Sanofi-aventis administrative office Israel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-aventis administrative office		Netanya			Israel

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D011471	Prostatic Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided