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Graz Osteoprotegerin as a Risk Factor (GORF) Study

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ClinicalTrials.gov Identifier: NCT01574963
Recruitment Status : Unknown
Verified April 2012 by Daniela Malliga, MD, Medical University of Graz.
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Daniela Malliga, MD, Medical University of Graz

Study Description
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Brief Summary:

Osteoprotegerin (OPG) is membrane bound in the immune system but can also be produced and secreted almost everywhere in the organism, so that it is mainly available in soluble form. So far, the OPG/RANKL/RANK system has been most intensively studied in bone. The binding of RANKL on its receptor RANK, which is expressed by osteoclasts, activates a number of osteoclastic cell functions. OPG also has a key function in the vascular system. Patients with coronary heart disease (CAD) have elevated OPG serum levels, probably as a sign of ischemic or inflammatory endothelial damage. Elevated OPG levels were also found in patients with advanced heart failure, whereby OPG correlated with pro BNP (brain natriuretic peptide) and was a predictor for cardiovascular morbidity and mortality.

Our prospective cohort study will include 150 men (75 patients requiring surgery for CAD and a control group without coronary heart disease). The primary endpoints are the differences between the two groups in serum levels of OPG and RANKL, markers of bone metabolism (osteocalcin [OC], crosslaps [CTX], tartrate resistant acid phosphatase (TRAP5b), 25(OH) vitamin D [Vit D], 1.25(OH) vitamin D, parathormone [iPTH], endocrine parameters related to vascular damage (e.g. aldosterone, renin and cortisol) and bone mineral density. Metabolomic based biomarkers will be evaluated to explore the mechanisms behind OPG-RANKL linked CVD damage. In the patients further studies of the mRNA expression of OPG, RANKL, TRAP5b, arginine:glycine amidinotransferase (AGAT) and osteocalcin in bone (sternum sliver) and vascular wall (aorta, internal thoracic artery and the great saphenous vein) will be performed.

A further study endpoint is the analysis of a causal coincidence between osteoporosis and CAD and the discrimination of possible key factors in the two entities. These will be determined by the correlation between the above-mentioned markers in serum and the expression in different vessels and in bone tissue.

In addition to analysis of the degree of vascular sclerosis, the mineral content of the bone will also be analyzed in a subpopulation with quantitative backscattered electron imaging (qBEI) related to the degree of vascular sclerosis and bone mineral density. The ultimate goal of the analysis is the discrimination of the most sensitive predictive marker(s) for diagnosis and outcome of patients with CAD for the purpose of early diagnosis and primary prevention of the disease.

CAD and osteoporosis are increasingly prevalent diseases that overlap. In both entities, OPG plays a role not only in pathogenesis but also as an outcome predictor. We aim to study the relevance of OPG concentration in serum but also in the vessel wall and the bone.


Condition or disease
Prevalent OPG and RANKL Excession in Patients With CAD

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Graz Osteoprotegerin as a Risk Factor (GORF) Study: THE ROLE of OSTEOPROTEGERIN (OPG) and the RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-Kb LIGAND (RANKL) IN PATIENTS REQUIRING SURGERY FOR CORONARY HEART DISEASE
Study Start Date : July 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : September 2012
Groups and Cohorts
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Group/Cohort
CAD Patients
Patients suffering from CAD requiring coronary artery bypass grafting
Control Patients
Patients without CAD


Outcome Measures
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Primary Outcome Measures :
  1. OSTEOPROTEGERIN (OPG) [ Time Frame: Baseline at time 0 (at the beginning of the study). The participants will be followed for the duration of hospital stay, an expected average of 10 days. ]
    The primary endpoints are the differences between the two groups in serum levels of OPG and RANKL, markers of bone metabolism (osteocalcin [OC], crosslaps [CTX], tartrate resistant acid phosphatase (TRAP5b), 25(OH) vitamin D [Vit D], 1.25(OH) vitamin D, parathormone [iPTH], endocrine parameters related to vascular damage (e.g. aldosterone, renin and cortisol) and bone mineral density.


Secondary Outcome Measures :
  1. RANKL [ Time Frame: At baseline. The participants will be followed for the duration of hospital stay, an expected average of 10 days. ]
    The primary endpoints are the differences between the two groups in serum levels of OPG and RANKL, markers of bone metabolism (osteocalcin [OC], crosslaps [CTX], tartrate resistant acid phosphatase (TRAP5b), 25(OH) vitamin D [Vit D], 1.25(OH) vitamin D, parathormone [iPTH], endocrine parameters related to vascular damage (e.g. aldosterone, renin and cortisol) and bone mineral density.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients above 40 years of age presenting with symptomatic CAD and scheduled for a coronary artery bypass graft (CABG) are eligible for the study. The control group includes male patients scheduled for elective surgery other than cardiac procedures.
Criteria

Inclusion Criteria:

  • Male patients above 40 years of age presenting with symptomatic CAD and scheduled for a coronary artery bypass graft (CABG) are eligible for the study. The control group includes male patients scheduled for elective surgery other than cardiac procedures.

Exclusion Criteria:

  • Exclusion criteria are a second indication for heart surgery, chronic renal disease with a glomerular filtration rate < 30ml/min, advanced liver disease (AST, ALT, GGT > 3fold upper limit of normal), history of malignancy within the last 5 years and ongoing osteoprotective treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574963


Contacts
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Contact: Daniela Malliga, MD 0043 316 385 ext 80651 daniela-eugenia.martin@medunigraz.at
Contact: Doris Wagner, MD 0043 316 385 ext 80651 doris.wagner@medunigraz.at

Locations
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Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Daniela Malliga, MD    0043 316 385 ext 80681    daniela-eugenia.martin@medunigraz.at   
Contact: Doris Wagner, MD    0043 316 385 ext 80651    doris.wagner@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Medical University of Vienna
Investigators
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Principal Investigator: Daniela Malliga, MD Medical University of Graz, Department of Surgery, Division for Cardiac Surgery
Study Director: Astrid Fahrleitner-Pammer, Prof. Medical University of Graz, Department of Internal Medicine, Division for Endocrinology and Metabolism
Study Chair: Doris Wagner, MD Medical University of Graz, Department of Surgery, Division for Transplantation
More Information
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Responsible Party: Daniela Malliga, MD, OA Dr. med. univ., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01574963    
Other Study ID Numbers: GORF 2.0
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012
Keywords provided by Daniela Malliga, MD, Medical University of Graz:
Coronary artery disease
OPG
RANKL
bone disease