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NCT00180232 Clinical Trial

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

Osteoporosis Clinical Trial

Official title:
An Open Clinical Trial to Assess the Influence of Newly Prescribed Aminobiphosphonates on Arterial Stiffness (Changes of the Aortal Elasticity Due to a Newly Established Aminobiphosphinate Therapy for the Treatment of Osteoporosis)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00180232
Other study ID # EK160082004
Secondary ID
Status Withdrawn
Phase N/A
First received September 14, 2005
Last updated February 2, 2012
Start date April 2006
Est. completion date June 2006

Study information
Verified date February 2012
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Medizinische Fakultät der Technischen Universität Dresden Dresden

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

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