OsteoporosisOSTRIANCT01677637
Osteoporosis Screening Trial
An observational study of Osteoporosis, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial summary
Osteoporosis is the most common disease of bone and characterized firstly by low bone mass and secondly, impaired bone microarchitecture structure resulting in reduced strength and increased risk of fracture. Read more about this study
- Who is it for?
- Ages 30 to 90 years, women only
- Conditions the study is for
- Osteoporosis
- How many people
- 5,500 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2012to Jul 2014
- 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 30 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal females screened for osteoporosis
Who may be able to join
- Females
- Postmenopausal women
- Outpatients screened for osteoporosis
- Women > 45 years
- Women < 45 years under menopause
- Women obtained their consent to be measured
Who cannot join
- Premenopausal females
- Women without any symptom of menopause
- Women not obtained their consent to be measured
Trial locations and contacts
1 site in 1 country.
Greece1 site
Iaso Hospital of Athens, Center of Endocrinology and Bone Metabolism
Athens, Kifisias Avenue, 37-39, Maroussi, 15123
About this study
Official title: Epidemiological, Observational, Multicenter Clinical Trial
Osteoporosis is the most common disease of bone and characterized firstly by low bone mass and secondly, impaired bone microarchitecture structure resulting in reduced strength and increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal Osteoporosis Osteoporosis \& elderly and senile osteoporosis) and secondary. The most common form is postmenopausal osteoporosis. It occurs in women after menopause and is associated with decreased estrogen production, which normally occurs at this age women Osteoporosis usually occurs after age 50, it is very common in women than in men, and its frequency increases with advancing age.
Read the detailed description
According to the findings of epidemiological studies in different countries, osteoporosis affects 25-35% of women and 15-20% of men aged 50 and over. In terms of our country in the recent nation-epidemiological research on rheumatic diseases in the general adult population, ie persons aged 19 and over, organized and conducted by the Greek Institute of Rheumatology Research, became a separate study on frequency of osteoporosis in women aged 50 years and above. These women was measured BMD at the lumbar spine and at the upper end of the femur and found that 28.4% of Greek women aged 50 and over have osteoporosis. It is indeed very interesting finding in this study that women who have osteoporosis, the vast majority, ie about 75%, I do not know. This is of particular importance and highlights the need to educate and inform systematically the public, especially women regarding both the modern possibilities for early diagnosis of osteoporosis, and for the implementation of primary and secondary prevention.
Osteoporosis is a major public health problem for two reasons: First, because it is common, and secondly because it has significant impact on patients and their families, the health system and the national economy.
The main clinical manifestation of osteoporosis is fractures low energy, ie fractures occurring after mild degree injury, eg fall from a standing position. Approximately 40% of cases osteoporotic fractures on the vertebrae, 20% in the femoral neck, 20% to 20% radius and several other bones. While osteoporosis is generally regarded as a disease of women, however, as already mentioned above, osteoporosis affects and men. It has even been found that 30% of osteoporotic fractures of the femoral neck and 20% of osteoporotic vertebral fractures occur in men.
The risk of fractures of the hip, vertebrae and radius increases with advancing age in both women and men. It has even been estimated that the risk of osteoporotic fracture in women aged 50 and over is 40-50% and 15-20% in men.
The adverse effects of osteoporosis patients and their families, the health system and the national economy due to fractures. Indicative only some of these effects:
- The mortality in patients with hip fractures and clinically symptomatic vertebral fractures is significantly higher than that observed in individuals of the same sex and similar age in the general population. For example, within the first year after the fracture approximately 20% of patients with hip fracture and 25% of patients with vertebral fracture die.
- One year after a hip fracture, only 50% of patients can execute without help ordinary activities of everyday life.
- On an annual basis the number of days of hospitalization for patients with osteoporotic fractures is significantly greater than the number of days of hospitalization required for patients with stroke or diabetes mellitus or myocardial infarction or breast cancer.
Moreover, in 2000 the European Union the then 15 Member States (total population of 379,000,000 people) is estimated to have occurred 3.79 million osteoporotic fractures and that the direct costs of these fractures (costs of hospitalization, surgery and medical care) was approximately 32 billion Euros.
- Conditions
- Osteoporosis
- Keywords
- osteopenia, postmenopausal
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
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 |
|---|---|---|
| All measurements | Total measured population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporosis Indicator
T-score per female as measured by Holofic Sahara Instrument
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 5,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aristeidis Kerasiotis, Endocrinologist, Study chair, Director of Endocrinology Unit ,'Iaso' Hospital of Athens, 37-39 Kifisias avenue, 15123, Athens, GreeceIoannis Lentzas, MD, Principal investigator, Director, Medical State Center, Simopoulo, Perfecture of IliaDimitrios Tsorntanidis, MD, Principal investigator, Registrat B', Medical State Center, Erymantheia, Achaia PerfectureMaria Chronopoulou, MD, Principal investigator, Registrat B', Medical State Site, Diakofto, Achaia PerfectureOlimpia Raftopoulou, MD, Principal investigator, Registrat B', Medical State Site, Myrsini, Perfecture of IliaStylianos Danelakis, GP, Principal investigator, Medical State Site, LeontariThomas Simos, GP, Principal investigator, Medical State Site, AnavraTheofanis Tsirogiannis, GP, Principal investigator, Medical State Site, Agnantero
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677637
- Sponsor's protocol ID
- 2011-BOD-EL-02
- Acronym
- OSTRIA
- Status last verified
- May 2013
- First submitted
- 30 Aug 2012
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kanis JA. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: synopsis of a WHO report. WHO Study Group. Osteoporos Int. 1994 Nov;4(6):368-81. doi: 10.1007/BF01622200.
PubMed 7696835McClung M. Difference in Distribution of T-scores Among Bone Density Tests in Postmenopausal Women. Bone Vol. 23, (5S), pg. S193, 1998.
Ikeda Y, Iki M, Morita A, Aihara H, Kagamimori S, Kagawa Y, Matsuzaki T, Yoneshima H, Marumo F; JPOS Study Group. Age-specific values and cutoff levels for the diagnosis of osteoporosis in quantitative ultrasound measurements at the calcaneus with SAHARA in healthy Japanese women: Japanese population-based osteoporosis (JPOS) study. Calcif Tissue Int. 2002 Jul;71(1):1-9. doi: 10.1007/s00223-001-2079-6. Epub 2002 Jun 20.
PubMed 12200654Magkos F, Manios Y, Babaroutsi E, Sidossis LS. Quantitative ultrasound calcaneus measurements: normative data for the Greek population. Osteoporos Int. 2005 Mar;16(3):280-8. doi: 10.1007/s00198-004-1670-x. Epub 2004 Jul 6.
PubMed 15241583
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Observational, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT01677637
- Acronym / sponsor ID
- OSTRIA / 2011-BOD-EL-02
- Conditions
- Osteoporosis
- Keywords
- osteopenia, postmenopausal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,500 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 3 Sep 2012 (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.
Osteoporosis is the most common disease of bone and characterized firstly by low bone mass and secondly, impaired bone microarchitecture structure resulting in reduced strength and increased risk of fracture. Osteoporosis is divided into: primary (Postmenopausal Osteoporosis Osteoporosis \& elderly and senile osteoporosis) and secondary. The most common form is postmenopausal osteoporosis. It occurs in women after menopause and is associated with decreased estrogen production, which normally occurs at this age women Osteoporosis usually occurs after age 50, it is very common in women than in men, and its frequency increases with advancing age.
Detailed description
According to the findings of epidemiological studies in different countries, osteoporosis affects 25-35% of women and 15-20% of men aged 50 and over. In terms of our country in the recent nation-epidemiological research on rheumatic diseases in the general adult population, ie persons aged 19 and over, organized and conducted by the Greek Institute of Rheumatology Research, became a separate study on frequency of osteoporosis in women aged 50 years and above. These women was measured BMD at the lumbar spine and at the upper end of the femur and found that 28.4% of Greek women aged 50 and over have osteoporosis. It is indeed very interesting finding in this study that women who have osteoporosis, the vast majority, ie about 75%, I do not know. This is of particular importance and highlights the need to educate and inform systematically the public, especially women regarding both the modern possibilities for early diagnosis of osteoporosis, and for the implementation of primary and secondary prevention.
Osteoporosis is a major public health problem for two reasons: First, because it is common, and secondly because it has significant impact on patients and their families, the health system and the national economy.
The main clinical manifestation of osteoporosis is fractures low energy, ie fractures occurring after mild degree injury, eg fall from a standing position. Approximately 40% of cases osteoporotic fractures on the vertebrae, 20% in the femoral neck, 20% to 20% radius and several other bones. While osteoporosis is generally regarded as a disease of women, however, as already mentioned above, osteoporosis affects and men. It has even been found that 30% of osteoporotic fractures of the femoral neck and 20% of osteoporotic vertebral fractures occur in men.
The risk of fractures of the hip, vertebrae and radius increases with advancing age in both women and men. It has even been estimated that the risk of osteoporotic fracture in women aged 50 and over is 40-50% and 15-20% in men.
The adverse effects of osteoporosis patients and their families, the health system and the national economy due to fractures. Indicative only some of these effects:
- The mortality in patients with hip fractures and clinically symptomatic vertebral fractures is significantly higher than that observed in individuals of the same sex and similar age in the general population. For example, within the first year after the fracture approximately 20% of patients with hip fracture and 25% of patients with vertebral fracture die.
- One year after a hip fracture, only 50% of patients can execute without help ordinary activities of everyday life.
- On an annual basis the number of days of hospitalization for patients with osteoporotic fractures is significantly greater than the number of days of hospitalization required for patients with stroke or diabetes mellitus or myocardial infarction or breast cancer.
Moreover, in 2000 the European Union the then 15 Member States (total population of 379,000,000 people) is estimated to have occurred 3.79 million osteoporotic fractures and that the direct costs of these fractures (costs of hospitalization, surgery and medical care) was approximately 32 billion Euros.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All measurements | – | –Total measured population |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal females screened for osteoporosis
Key inclusion criteria (6 listed)
- Females
- Postmenopausal women
- Outpatients screened for osteoporosis
- Women > 45 years
- Women < 45 years under menopause
Key exclusion criteria (3 listed)
- Premenopausal females
- Women without any symptom of menopause
- Women not obtained their consent to be measured
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
Osteoporosis Indicator
Time frame: 1 year
T-score per female as measured by Holofic Sahara Instrument
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 19 Aug 2014.
- Background: PubMed 7696835Kanis JA. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: synopsis of a WHO report. WHO Study Group. Osteoporos Int. 1994 Nov;4(6):368-81. doi: 10.1007/BF01622200.
- BackgroundMcClung M. Difference in Distribution of T-scores Among Bone Density Tests in Postmenopausal Women. Bone Vol. 23, (5S), pg. S193, 1998.
- Background: PubMed 12200654Ikeda Y, Iki M, Morita A, Aihara H, Kagamimori S, Kagawa Y, Matsuzaki T, Yoneshima H, Marumo F; JPOS Study Group. Age-specific values and cutoff levels for the diagnosis of osteoporosis in quantitative ultrasound measurements at the calcaneus with SAHARA in healthy Japanese women: Japanese population-based osteoporosis (JPOS) study. Calcif Tissue Int. 2002 Jul;71(1):1-9. doi: 10.1007/s00223-001-2079-6. Epub 2002 Jun 20.
- Background: PubMed 15241583Magkos F, Manios Y, Babaroutsi E, Sidossis LS. Quantitative ultrasound calcaneus measurements: normative data for the Greek population. Osteoporos Int. 2005 Mar;16(3):280-8. doi: 10.1007/s00198-004-1670-x. Epub 2004 Jul 6.
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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.
Aristeidis Kerasiotis, Endocrinologist study chair
Director of Endocrinology Unit ,'Iaso' Hospital of Athens, 37-39 Kifisias avenue, 15123, Athens, Greece
Ioannis Lentzas, MD principal investigator
Director, Medical State Center, Simopoulo, Perfecture of Ilia
Dimitrios Tsorntanidis, MD principal investigator
Registrat B', Medical State Center, Erymantheia, Achaia Perfecture
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 Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
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 6 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 19 Aug 2014. 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 Greece. 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?
Osteoporosis Indicator (time frame: 1 year). 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 NCT01677637, which also lists 4 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 19 Aug 2014.