CClinicalTrials.gg
CompletedNCT01677637OSTRIAUpdated Aug 19, 2014

Osteoporosis Screening Trial

An observational study in Osteoporosis, sponsored by Elpen Pharmaceutical Co. Inc.. Completed at 1 site in Greece. Open to female participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2014-08-19.

Sponsored by Elpen Pharmaceutical Co. Inc. · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
5,500
Ages
30 Years to 90 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Osteoporosis

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Keywords

  • osteopenia, postmenopausal
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In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 5,500 is above the median of 174 across 446 observational studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Elpen Pharmaceutical Co. Inc. is the lead sponsor of 43 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Postmenopausal females screened for osteoporosis

Inclusion criteria

  • Females
  • Postmenopausal women
  • Outpatients screened for osteoporosis
  • Women > 45 years
  • Women \< 45 years under menopause
  • Women obtained their consent to be measured

Exclusion criteria

Exclusion Criteria:

  • Premenopausal females
  • Women without any symptom of menopause
  • Women not obtained their consent to be measured
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Study design

Time perspective
Prospective
Enrollment
5,500 participants (actual)

Groups and cohorts

  • All measurements

    Total measured population

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What researchers measure

Primary outcomes

  1. Osteoporosis Indicator

    T-score per female as measured by Holofic Sahara Instrument

    Time frame: 1 year

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Study locations

1 site
  • Iaso Hospital of Athens, Center of Endocrinology and Bone Metabolism
    Athens, Kifisias Avenue, 37-39, Maroussi 15123, Greece
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01677637
Lead sponsor
Elpen Pharmaceutical Co. Inc.
Responsible party
Sponsor
First posted
Sep 3, 2012
Start date
Feb 2012
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Aug 19, 2014

Study contacts

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
Maria Chronopoulou, MD
principal investigator · Registrat B', Medical State Site, Diakofto, Achaia Perfecture
Olimpia Raftopoulou, MD
principal investigator · Registrat B', Medical State Site, Myrsini, Perfecture of Ilia
Stylianos Danelakis, GP
principal investigator · Medical State Site, Leontari
Thomas Simos, GP
principal investigator · Medical State Site, Anavra
Theofanis Tsirogiannis, GP
principal investigator · Medical State Site, Agnantero
Konstantinos Vatalis, GP
principal investigator · Medical State Site, Tsartsani
Ioannis Antonopoulos, GP
principal investigator · Medical State Site, Ampelonas
Labros Kontovos, GP
principal investigator · Medical State Site, Nikaia, Perfecture of Larisa
Chara Kalliora, GP
principal investigator · Medical State Site, Gomfon, Perfecture of Trikala
Athanasios Misios, GP
principal investigator · Medical State Site, Megala Kalyvia
Antonis Monastiriotis, GP
principal investigator · Medical State Site, Oropos - Chalkoutsi
Zeppos Monstratos, GP
principal investigator · Medical State Site, Marathonas
George Sakellaropoulos, Orthop.
principal investigator · Medical State Site, Marathonas
Andreas Sotiriou, Orthop.
principal investigator · Private Office, Zografou, Athens
Maria Degaiti, GP
principal investigator · Medical State Site, Ano Mera, Island of Mykonos
Aristeidis Frydas, Medical Internist
principal investigator · Director, Medical State Center, Plomari, Island of Lesvos
Nikolaos Tsamouras, GP
principal investigator · Medical State Center, Agiassos, Island of Lesvos
Ioannis Komninos, GP
principal investigator · Medical State Center of Neapolis
Nikolaos Tsakountakis, GP
principal investigator · Medical State Center of Kastelli, Creta Island
Emmanouel Paterakis, GP
principal investigator · Private Madical Office, Heraklion, Creta Island
Panagiota Gourgoulia, MD
principal investigator · Regional State Medical Center of Giannouli - Tyrnavos, Perfecture of Larisa, Greece
Zisis Kelepouris, GP
principal investigator · Regional State Medical Center Platanos-Raxa, Perfecture of Trikala, Greece
Christos Ganochoritis, GP
principal investigator · Medical State Center of Pyrgetos and Egani, Regional Perfecture of Larisa
Demetra Zambouka, GP
principal investigator · Medical State Center of Agioi Anargyri, Regional Perfecture of Larisa
Charalampos Terzopoulos, MD, Orthopedics
principal investigator · Private office, Zografou, Athens, Greece
John Sakellariou, MD, Pathology, Registrat A
principal investigator · Medical Center of Farkadona, Thessalia, Greece
Aglaia Roganaki, MD, Registrat B,
principal investigator · Peripheral Medical Center of Mitropolis, Thessalia, Greece
Vasilis Delezos, MD, Registrat B
principal investigator · Medical Center of Sophades, Thessalia, Greece
Victoria Katsouri, MD, Registrat B
principal investigator · Medical Center of Sophades, Thessalia, Greece
Maria Papala, MD
principal investigator · State Medical Center of Tyrnavos, Thessalia, Greece
Styliani Papakosta, MD, Phyciatry
principal investigator · Medical Private Office, Larisa, Greece
Athanasios Tsivgoulis, MD in Physiatry
principal investigator · Medical Diagnosis Center, Lesvos Island, Greece
Petros Prokopis, MD
principal investigator · Medical Office of Avlona
George Papadimitriou, MD, Orthopedics
principal investigator · Private Medical Office, Vari Attikis
Vasilios Hamos, MD, Director
principal investigator · State Medical Cener, Agia, Larissa
Lemonia Arvanitakou, MD
principal investigator · State Medical Center, Agia, Larissa
Victoria Rizou, MD
principal investigator · State Medical Office, Halki, Larissa
Vassiliki Mamakou, MD, Internist
principal investigator · Mytilini
Antonios Partsinevelos, MD, Orth
principal investigator · Private Office, Marousi, Athens
George Patoulis, MD, Orth
principal investigator · Private Office, Marousi, Athens

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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