OsteoporosisATPBoneNCT00697983
Cohort Study on Associations Between Purinergic Receptor SNPs and Osteoporosis Risk
An observational study of Osteoporosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2008to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Fracture patients of 50 years and older attending an osteoporosis outpatient clinic at the Maastricht University Medical Center
Who may be able to join
- Age 50 years and older;
- Clinical fracture;
- Attending osteoporosis outpatient clinic for standard medical care.
Who cannot join
- Disease of bone metabolism (e.g. bone tumours, hyperparathyroidism);
- Unwillingness to donate blood for DNA analyses;
- Failure of bone densitometry (DXA-scan).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg
About this study
Official title: Purinergic Signalling in Human Osteoporosis: Evaluation of Variability in Purinergic Receptor Genes and Receptor Function
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.
Read more
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.
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, ATP, Purinergic receptors, Bone mineral density, Single nucleotide polymorphism
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purinergic receptor SNPs
Measured: cross-sectional
BMD
Measured: cross-sectional
Secondary outcomes (1)
Biochemical markers of bone turnover
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Research Center for Aging and Osteoporosis, European Commission
- Investigators
- Pieter C Dagnelie, PhD, Principal investigator, Maastricht University, Dept of Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697983
- Sponsor's protocol ID
- MEC 08-3-029
- Other IDs
- EU FP7, grant no. 202231
- Acronym
- ATPBone
- Status last verified
- Apr 2011
- First submitted
- 11 Jun 2008
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
van Helden S, van Geel AC, Geusens PP, Kessels A, Nieuwenhuijzen Kruseman AC, Brink PR. Bone and fall-related fracture risks in women and men with a recent clinical fracture. J Bone Joint Surg Am. 2008 Feb;90(2):241-8. doi: 10.2106/JBJS.G.00150.
PubMed 18245581Ohlendorff SD, Tofteng CL, Jensen JE, Petersen S, Civitelli R, Fenger M, Abrahamsen B, Hermann AP, Eiken P, Jorgensen NR. Single nucleotide polymorphisms in the P2X7 gene are associated to fracture risk and to effect of estrogen treatment. Pharmacogenet Genomics. 2007 Jul;17(7):555-67. doi: 10.1097/FPC.0b013e3280951625.
PubMed 17558311Hoebertz A, Arnett TR, Burnstock G. Regulation of bone resorption and formation by purines and pyrimidines. Trends Pharmacol Sci. 2003 Jun;24(6):290-7. doi: 10.1016/S0165-6147(03)00123-8.
PubMed 12823955Bours MJ, Swennen EL, Di Virgilio F, Cronstein BN, Dagnelie PC. Adenosine 5'-triphosphate and adenosine as endogenous signaling molecules in immunity and inflammation. Pharmacol Ther. 2006 Nov;112(2):358-404. doi: 10.1016/j.pharmthera.2005.04.013. Epub 2006 Jun 19.
PubMed 16784779Swennen EL, Bast A, Dagnelie PC. Purinergic receptors involved in the immunomodulatory effects of ATP in human blood. Biochem Biophys Res Commun. 2006 Sep 29;348(3):1194-9. doi: 10.1016/j.bbrc.2006.07.177. Epub 2006 Aug 4.
PubMed 16904065Bours 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Purinergic Signalling in Human Osteoporosis: Evaluation of Variability in Purinergic Receptor Genes and Receptor Function
- ClinicalTrials.gov ID
- NCT00697983
- Acronym / sponsor ID
- ATPBone / MEC 08-3-029
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, ATP, Purinergic receptors, Bone mineral density, Single nucleotide polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Research Center for Aging and Osteoporosis, European Commission
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Fracture patients of 50 years and older attending an osteoporosis outpatient clinic at the Maastricht University Medical Center
Key inclusion criteria (3 listed)
- Age 50 years and older;
- Clinical fracture;
- Attending osteoporosis outpatient clinic for standard medical care.
Key exclusion criteria (3 listed)
- Disease of bone metabolism (e.g. bone tumours, hyperparathyroidism);
- Unwillingness to donate blood for DNA analyses;
- Failure of bone densitometry (DXA-scan).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Purinergic receptor SNPs
Time frame: cross-sectional
BMD
Time frame: cross-sectional
1 secondary outcome
Biochemical markers of bone turnover
Time frame: cross-sectional
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2011.
- Background: PubMed 18245581van Helden S, van Geel AC, Geusens PP, Kessels A, Nieuwenhuijzen Kruseman AC, Brink PR. Bone and fall-related fracture risks in women and men with a recent clinical fracture. J Bone Joint Surg Am. 2008 Feb;90(2):241-8. doi: 10.2106/JBJS.G.00150.
- Background: PubMed 17558311Ohlendorff SD, Tofteng CL, Jensen JE, Petersen S, Civitelli R, Fenger M, Abrahamsen B, Hermann AP, Eiken P, Jorgensen NR. Single nucleotide polymorphisms in the P2X7 gene are associated to fracture risk and to effect of estrogen treatment. Pharmacogenet Genomics. 2007 Jul;17(7):555-67. doi: 10.1097/FPC.0b013e3280951625.
- Background: PubMed 12823955Hoebertz A, Arnett TR, Burnstock G. Regulation of bone resorption and formation by purines and pyrimidines. Trends Pharmacol Sci. 2003 Jun;24(6):290-7. doi: 10.1016/S0165-6147(03)00123-8.
- Background: PubMed 16784779Bours MJ, Swennen EL, Di Virgilio F, Cronstein BN, Dagnelie PC. Adenosine 5'-triphosphate and adenosine as endogenous signaling molecules in immunity and inflammation. Pharmacol Ther. 2006 Nov;112(2):358-404. doi: 10.1016/j.pharmthera.2005.04.013. Epub 2006 Jun 19.
- Background: PubMed 16904065Swennen EL, Bast A, Dagnelie PC. Purinergic receptors involved in the immunomodulatory effects of ATP in human blood. Biochem Biophys Res Commun. 2006 Sep 29;348(3):1194-9. doi: 10.1016/j.bbrc.2006.07.177. Epub 2006 Aug 4.
- BackgroundBours 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.
- European Commission Research, Seventh Framework ProgrammeLink provided by the sponsor.
- University Hospital MaastrichtLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter C Dagnelie, PhD principal investigator
Maastricht University, Dept of Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Purinergic receptor SNPs (time frame: cross-sectional). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00697983, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2011.