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OsteoporosisOSTRIANCT01677637

Osteoporosis Screening Trial

An observational study of Osteoporosis, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Greece

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 groups in NCT01677637
Study groupRoleWhat they receive
All measurementsTotal measured population

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted3 Sep 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

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)
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 7696835
  • McClung 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 12200654
  • Magkos 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

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.

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Osteoporosis Screening Trial (NCT01677637) | AzTrials