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

This study has been withdrawn prior to enrollment.
(Clinical partner left University,)
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00180232
First received: September 14, 2005
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition
Arteriosclerosis
Osteoporosis

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Enrollment: 0
Study Start Date: April 2006
Study Completion Date: June 2006
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180232

Locations
Germany
Medizinische Fakultät der Technischen Universität Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Dresden University of Technology
Investigators
Principal Investigator: Joachim Siegert, MDDPharm,Phd Technische Universität Dresden
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180232     History of Changes
Other Study ID Numbers: EK160082004
Study First Received: September 14, 2005
Last Updated: February 2, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Arteriosclerosis
Osteoporosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 16, 2013