Clinical trial NCT01677637: Osteoporosis Screening Trial
Official title: Epidemiological, Observational, Multicenter Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: osteopenia, postmenopausal
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-03
Enrollment: 5500
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal females screened for osteoporosis

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.

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

Primary outcomes:
measure: Osteoporosis Indicator
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Iaso Hospital of Athens, Center of Endocrinology and Bone Metabolism
state: Kifisias Avenue, 37-39, Maroussi
Study officials:
affiliation: Director of Endocrinology Unit ,'Iaso' Hospital of Athens, 37-39 Kifisias avenue, 15123, Athens, Greece
name: Aristeidis Kerasiotis, Endocrinologist
role: STUDY_CHAIR
affiliation: Director, Medical State Center, Simopoulo, Perfecture of Ilia
name: Ioannis Lentzas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Registrat B', Medical State Center, Erymantheia, Achaia Perfecture
name: Dimitrios Tsorntanidis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Registrat B', Medical State Site, Diakofto, Achaia Perfecture
name: Maria Chronopoulou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Registrat B', Medical State Site, Myrsini, Perfecture of Ilia
name: Olimpia Raftopoulou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Leontari
name: Stylianos Danelakis, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Anavra
name: Thomas Simos, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Agnantero
name: Theofanis Tsirogiannis, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Tsartsani
name: Konstantinos Vatalis, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Ampelonas
name: Ioannis Antonopoulos, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Nikaia, Perfecture of Larisa
name: Labros Kontovos, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Gomfon, Perfecture of Trikala
name: Chara Kalliora, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Megala Kalyvia
name: Athanasios Misios, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Oropos - Chalkoutsi
name: Antonis Monastiriotis, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Marathonas
name: Zeppos Monstratos, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Marathonas
name: George Sakellaropoulos, Orthop.
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Office, Zografou, Athens
name: Andreas Sotiriou, Orthop.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Site, Ano Mera, Island of Mykonos
name: Maria Degaiti, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Director, Medical State Center, Plomari, Island of Lesvos
name: Aristeidis Frydas, Medical Internist
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Center, Agiassos, Island of Lesvos
name: Nikolaos Tsamouras, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Center of Neapolis
name: Ioannis Komninos, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Center of Kastelli, Creta Island
name: Nikolaos Tsakountakis, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Madical Office, Heraklion, Creta Island
name: Emmanouel Paterakis, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional State Medical Center of Giannouli - Tyrnavos, Perfecture of Larisa, Greece
name: Panagiota Gourgoulia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional State Medical Center Platanos-Raxa, Perfecture of Trikala, Greece
name: Zisis Kelepouris, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Center of Pyrgetos and Egani, Regional Perfecture of Larisa
name: Christos Ganochoritis, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical State Center of Agioi Anargyri, Regional Perfecture of Larisa
name: Demetra Zambouka, GP
role: PRINCIPAL_INVESTIGATOR
affiliation: Private office, Zografou, Athens, Greece
name: Charalampos Terzopoulos, MD, Orthopedics
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Center of Farkadona, Thessalia, Greece
name: John Sakellariou, MD, Pathology, Registrat A
role: PRINCIPAL_INVESTIGATOR
affiliation: Peripheral Medical Center of Mitropolis, Thessalia, Greece
name: Aglaia Roganaki, MD, Registrat B,
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Center of Sophades, Thessalia, Greece
name: Vasilis Delezos, MD, Registrat B
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Center of Sophades, Thessalia, Greece
name: Victoria Katsouri, MD, Registrat B
role: PRINCIPAL_INVESTIGATOR
affiliation: State Medical Center of Tyrnavos, Thessalia, Greece
name: Maria Papala, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Private Office, Larisa, Greece
name: Styliani Papakosta, MD, Phyciatry
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Diagnosis Center, Lesvos Island, Greece
name: Athanasios Tsivgoulis, MD in Physiatry
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Office of Avlona
name: Petros Prokopis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Medical Office, Vari Attikis
name: George Papadimitriou, MD, Orthopedics
role: PRINCIPAL_INVESTIGATOR
affiliation: State Medical Cener, Agia, Larissa
name: Vasilios Hamos, MD, Director
role: PRINCIPAL_INVESTIGATOR
affiliation: State Medical Center, Agia, Larissa
name: Lemonia Arvanitakou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: State Medical Office, Halki, Larissa
name: Victoria Rizou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mytilini
name: Vassiliki Mamakou, MD, Internist
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Office, Marousi, Athens
name: Antonios Partsinevelos, MD, Orth
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Office, Marousi, Athens
name: George Patoulis, MD, Orth
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: McClung M. Difference in Distribution of T-scores Among Bone Density Tests in Postmenopausal Women. Bone Vol. 23, (5S), pg. S193, 1998.
citation: 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.
citation: 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.