An Open Clinical Trial to Assess the Influence of Newly P... | NCT00180232

Studies
An Open Clinical Trial to Assess the Influence of Newly Prescribed Aminobiphosphonates on Arterial Stiffness

NCT00180232

Sponsor

Technische Universität Dresden

Status

Withdrawn

Last Update Posted

Feb 3, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Arteriosclerosis
Osteoporosis

Interventions

Not provided

Countries

Germany

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

Feb 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Clinical partner left University,

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Not provided

Completion Date

Jun 2006Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 16, 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

Feb 2, 2012

Last Update Posted Date

Feb 3, 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

The study tries to reveal if aminobisphosphonates influence aside the bone density also the vascular status in the typical elderly patient population

Detailed Description

The subjects - starting bisphosphonate treatment due to medical reasons - will be additionally investigated as outpatients (arterial stiffness, applanation tonometry), for each subject 3 individual dates with a duration of approx. 30 min each are scheduled, prior to therapy with bisphosphonate, after 3 and 6 month of treatment

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients starting an aminobisphosphonate therapy due to medical reasons Broca-index: between -20 and +25% who are willing and capable to confirm written consent to enrolment after ample information has been provided

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients starting an aminobisphosphonate therapy due to medical reasons Broca-index: between -20 and +25% who are willing and capable to confirm written consent to enrolment after ample information has been provided

Exclusion Criteria:

patients with major cardiovascular disease patients participating in another clinical trial 1month prior to inclusion in this study patients unable or unwilling to give informed consent

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

Patients starting an aminobisphosphonate therapy due to medical reasons Broca-index: between -20 and +25%

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Siegert, MDDPharm,Phd	Technische Universität Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Fakultät der Technischen Universität Dresden		Dresden		01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001161	Arteriosclerosis
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001851	Bone Diseases, Metabolic

Browse Leaves

Not provided

Browse Branches

Not provided