Osteoporosis Screening Trial

NCT ID: NCT01677637

Last Updated: 2014-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-07-31

Brief 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.

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

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

All measurements

Total measured population

No interventions assigned to this group

Eligibility Criteria

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

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Elpen Pharmaceutical Co. Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aristeidis Kerasiotis, Endocrinologist

Role: STUDY_CHAIR

Director of Endocrinology Unit ,'Iaso' Hospital of Athens, 37-39 Kifisias avenue, 15123, Athens, Greece

Ioannis Lentzas, MD

Role: PRINCIPAL_INVESTIGATOR

Director, Medical State Center, Simopoulo, Perfecture of Ilia

Dimitrios Tsorntanidis, MD

Role: PRINCIPAL_INVESTIGATOR

Registrat B', Medical State Center, Erymantheia, Achaia Perfecture

Maria Chronopoulou, MD

Role: PRINCIPAL_INVESTIGATOR

Registrat B', Medical State Site, Diakofto, Achaia Perfecture

Olimpia Raftopoulou, MD

Role: PRINCIPAL_INVESTIGATOR

Registrat B', Medical State Site, Myrsini, Perfecture of Ilia

Stylianos Danelakis, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Leontari

Thomas Simos, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Anavra

Theofanis Tsirogiannis, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Agnantero

Konstantinos Vatalis, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Tsartsani

Ioannis Antonopoulos, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Ampelonas

Labros Kontovos, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Nikaia, Perfecture of Larisa

Chara Kalliora, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Gomfon, Perfecture of Trikala

Athanasios Misios, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Megala Kalyvia

Antonis Monastiriotis, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Oropos - Chalkoutsi

Zeppos Monstratos, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Marathonas

George Sakellaropoulos, Orthop.

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Marathonas

Andreas Sotiriou, Orthop.

Role: PRINCIPAL_INVESTIGATOR

Private Office, Zografou, Athens

Maria Degaiti, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Site, Ano Mera, Island of Mykonos

Aristeidis Frydas, Medical Internist

Role: PRINCIPAL_INVESTIGATOR

Director, Medical State Center, Plomari, Island of Lesvos

Nikolaos Tsamouras, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Center, Agiassos, Island of Lesvos

Ioannis Komninos, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Center of Neapolis

Nikolaos Tsakountakis, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Center of Kastelli, Creta Island

Emmanouel Paterakis, GP

Role: PRINCIPAL_INVESTIGATOR

Private Madical Office, Heraklion, Creta Island

Panagiota Gourgoulia, MD

Role: PRINCIPAL_INVESTIGATOR

Regional State Medical Center of Giannouli - Tyrnavos, Perfecture of Larisa, Greece

Zisis Kelepouris, GP

Role: PRINCIPAL_INVESTIGATOR

Regional State Medical Center Platanos-Raxa, Perfecture of Trikala, Greece

Christos Ganochoritis, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Center of Pyrgetos and Egani, Regional Perfecture of Larisa

Demetra Zambouka, GP

Role: PRINCIPAL_INVESTIGATOR

Medical State Center of Agioi Anargyri, Regional Perfecture of Larisa

Charalampos Terzopoulos, MD, Orthopedics

Role: PRINCIPAL_INVESTIGATOR

Private office, Zografou, Athens, Greece

John Sakellariou, MD, Pathology, Registrat A

Role: PRINCIPAL_INVESTIGATOR

Medical Center of Farkadona, Thessalia, Greece

Aglaia Roganaki, MD, Registrat B,

Role: PRINCIPAL_INVESTIGATOR

Peripheral Medical Center of Mitropolis, Thessalia, Greece

Vasilis Delezos, MD, Registrat B

Role: PRINCIPAL_INVESTIGATOR

Medical Center of Sophades, Thessalia, Greece

Victoria Katsouri, MD, Registrat B

Role: PRINCIPAL_INVESTIGATOR

Medical Center of Sophades, Thessalia, Greece

Maria Papala, MD

Role: PRINCIPAL_INVESTIGATOR

State Medical Center of Tyrnavos, Thessalia, Greece

Styliani Papakosta, MD, Phyciatry

Role: PRINCIPAL_INVESTIGATOR

Medical Private Office, Larisa, Greece

Athanasios Tsivgoulis, MD in Physiatry

Role: PRINCIPAL_INVESTIGATOR

Medical Diagnosis Center, Lesvos Island, Greece

Petros Prokopis, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Office of Avlona

George Papadimitriou, MD, Orthopedics

Role: PRINCIPAL_INVESTIGATOR

Private Medical Office, Vari Attikis

Vasilios Hamos, MD, Director

Role: PRINCIPAL_INVESTIGATOR

State Medical Cener, Agia, Larissa

Lemonia Arvanitakou, MD

Role: PRINCIPAL_INVESTIGATOR

State Medical Center, Agia, Larissa

Victoria Rizou, MD

Role: PRINCIPAL_INVESTIGATOR

State Medical Office, Halki, Larissa

Vassiliki Mamakou, MD, Internist

Role: PRINCIPAL_INVESTIGATOR

Mytilini

Antonios Partsinevelos, MD, Orth

Role: PRINCIPAL_INVESTIGATOR

Private Office, Marousi, Athens

George Patoulis, MD, Orth

Role: PRINCIPAL_INVESTIGATOR

Private Office, Marousi, Athens

Locations

Iaso Hospital of Athens, Center of Endocrinology and Bone Metabolism

Athens, Kifisias Avenue, 37-39, Maroussi, Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 7696835 (View on PubMed)

McClung M. Difference in Distribution of T-scores Among Bone Density Tests in Postmenopausal Women. Bone Vol. 23, (5S), pg. S193, 1998.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 12200654 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15241583 (View on PubMed)

Other Identifiers

2011-BOD-EL-02

Identifier Type: -

Identifier Source: org_study_id