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Cohort Study on Associations Between Purinergic Receptor SNPs and Osteoporosis Risk (ATPBone)

This study has been completed.
Sponsor:
Collaborators:
Copenhagen University Hospital, Research Center for Aging and Osteoporosis
European Commission
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00697983
First received: June 11, 2008
Last updated: April 19, 2011
Last verified: April 2011
History of Changes
  Purpose

Background: Osteoporosis is a high-prevalence disease with a strong genetic component. Nucleotides, including ATP (adenosine 5'-triphosphate) and its purinergic receptors, play a role in bone physiology. Single nucleotide polymorphisms (SNPs) in the P2X7 receptor gene were recently found to be associated with fracture risk in a cohort of postmenopausal women.

Objective: To investigate associations between purinergic receptor SNPs and osteoporosis risk in humans. Genetic data from a fracture cohort in the Netherlands with high prevalence of osteoporosis will be analyzed. Furthermore, effects of aberrant purinergic receptor signalling on bone turnover markers will be assessed ex vivo.

Design: The cohort will include app. 1,000 fracture patients of 50 years and older, who will be recruited at the Maastricht University Medical Center during standard medical follow-up after a clinical fracture. The standard medical follow-up includes assessment of bone mineral density (BMD) by Dual-Energy X-ray Absorptiometry (DXA), if necessary followed by medication for osteoporosis. Prior to medication, blood samples will be collected from fracture patients to be genotyped for purinergic receptor SNPs and analyzed for biochemical markers of bone turnover. Systemic correlates of osteoporosis will be compared between osteoporotic subjects (i.e. low BMD) and non-osteoporotic controls (i.e. normal to high BMD). Subsequently, whole blood assays in patient subgroups (n=20 per subgroup), based on BMD and purinergic receptor SNPs, will be performed to evaluate ex vivo effects of ATP and related nucleotides bone markers.

Study population: Patients of 50 years and older attending an outpatient osteoporosis clinic at the Maastricht University Medical Center for standard medical follow-up after a clinical, non-pathological fracture.

Primary outcome parameters: BMD and purinergic receptor SNPs.

Secondary outcome parameters: Bone markers.


Condition
Osteoporosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Purinergic Signalling in Human Osteoporosis: Evaluation of Variability in Purinergic Receptor Genes and Receptor Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Purinergic receptor SNPs [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]
  • BMD [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical markers of bone turnover [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma


Estimated Enrollment: 1000
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fracture cohort
Patients of 50 years and above with a clinical, non-pathological fracture, who attend an osteoporosis outpatient clinic at the Maastricht University Medical Center for standard medical care (including bone densitometry by DXA-scan).

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Fracture patients of 50 years and older attending an osteoporosis outpatient clinic at the Maastricht University Medical Center

Criteria

Inclusion Criteria:

  • Age 50 years and older;
  • Clinical fracture;
  • Attending osteoporosis outpatient clinic for standard medical care.

Exclusion Criteria:

  • Disease of bone metabolism (e.g. bone tumours, hyperparathyroidism);
  • Unwillingness to donate blood for DNA analyses;
  • Failure of bone densitometry (DXA-scan).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697983

Locations
Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Copenhagen University Hospital, Research Center for Aging and Osteoporosis
European Commission
Investigators
Principal Investigator: Pieter C Dagnelie, PhD Maastricht University, Dept of Epidemiology
  More Information

Additional Information:
European Nucleotides and Bone Consortium  This link exits the ClinicalTrials.gov site
European Commission Research, Seventh Framework Programme  This link exits the ClinicalTrials.gov site
University Hospital Maastricht  This link exits the ClinicalTrials.gov site
Maastricht University, Dept of Epidemiology  This link exits the ClinicalTrials.gov site

Publications:
Bours MJL, Wesselius A en Dagnelie PC. Adenosinetrifosfaat (ATP), purinerge receptoren en botremodellering. Nieuwe perspectieven voor behandeling van osteoporose? Ned Tijdschr Calcium Botstofwisseling 2009; 7(3):71-4.

Responsible Party: dr. ir. P.C. Dagnelie, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00697983     History of Changes
Other Study ID Numbers: MEC 08-3-029, EU FP7, grant no. 202231
Study First Received: June 11, 2008
Last Updated: April 19, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Osteoporosis
ATP
Purinergic receptors
Bone mineral density
Single nucleotide polymorphism

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 17, 2013