Osteoporosis Screening Trial (OSTRIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Elpen Pharmaceutical Co. Inc.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01677637
First received: August 30, 2012
Last updated: November 4, 2013
Last verified: May 2013
  Purpose

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.


Condition
Osteoporosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Epidemiological, Observational, Multicenter Clinical Trial

Resource links provided by NLM:


Further study details as provided by Elpen Pharmaceutical Co. Inc.:

Primary Outcome Measures:
  • Osteoporosis Indicator [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    T-score per female as measured by Holofic Sahara Instrument


Estimated Enrollment: 5500
Study Start Date: February 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
All measurements
Total measured population

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

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Postmenopausal females screened for osteoporosis

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677637

Contacts
Contact: Aristeidis Kerasotis, MD, Endocrinologist 00302106185229 akerasotis@ath.forthnet.gr

Locations
Greece
Iaso Hospital of Athens, Center of Endocrinology and Bone Metabolism Recruiting
Athens, Kifisias Avenue, 37-39, Maroussi, Greece, 15123
Principal Investigator: Aristeidis Kerasotis, Endocrinologist         
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
Study Chair: Aristeidis Kerasiotis, Endocrinologist Director of Endocrinology Unit ,'Iaso' Hospital of Athens, 37-39 Kifisias avenue, 15123, Athens, Greece
Principal Investigator: Ioannis Lentzas, MD Director, Medical State Center, Simopoulo, Perfecture of Ilia
Principal Investigator: Dimitrios Tsorntanidis, MD Registrat B', Medical State Center, Erymantheia, Achaia Perfecture
Principal Investigator: Maria Chronopoulou, MD Registrat B', Medical State Site, Diakofto, Achaia Perfecture
Principal Investigator: Olimpia Raftopoulou, MD Registrat B', Medical State Site, Myrsini, Perfecture of Ilia
Principal Investigator: Stylianos Danelakis, GP Medical State Site, Leontari
Principal Investigator: Thomas Simos, GP Medical State Site, Anavra
Principal Investigator: Theofanis Tsirogiannis, GP Medical State Site, Agnantero
Principal Investigator: Konstantinos Vatalis, GP Medical State Site, Tsartsani
Principal Investigator: Ioannis Antonopoulos, GP Medical State Site, Ampelonas
Principal Investigator: Labros Kontovos, GP Medical State Site, Nikaia, Perfecture of Larisa
Principal Investigator: Chara Kalliora, GP Medical State Site, Gomfon, Perfecture of Trikala
Principal Investigator: Athanasios Misios, GP Medical State Site, Megala Kalyvia
Principal Investigator: Antonis Monastiriotis, GP Medical State Site, Oropos - Chalkoutsi
Principal Investigator: Zeppos Monstratos, GP Medical State Site, Marathonas
Principal Investigator: George Sakellaropoulos, Orthop. Medical State Site, Marathonas
Principal Investigator: Andreas Sotiriou, Orthop. Private Office, Zografou, Athens
Principal Investigator: Maria Degaiti, GP Medical State Site, Ano Mera, Island of Mykonos
Principal Investigator: Aristeidis Frydas, Medical Internist Director, Medical State Center, Plomari, Island of Lesvos
Principal Investigator: Nikolaos Tsamouras, GP Medical State Center, Agiassos, Island of Lesvos
Principal Investigator: Ioannis Komninos, GP Medical State Center of Neapolis
Principal Investigator: Nikolaos Tsakountakis, GP Medical State Center of Kastelli, Creta Island
Principal Investigator: Emmanouel Paterakis, GP Private Madical Office, Heraklion, Creta Island
Principal Investigator: Panagiota Gourgoulia, MD Regional State Medical Center of Giannouli - Tyrnavos, Perfecture of Larisa, Greece
Principal Investigator: Zisis Kelepouris, GP Regional State Medical Center Platanos-Raxa, Perfecture of Trikala, Greece
Principal Investigator: Christos Ganochoritis, GP Medical State Center of Pyrgetos and Egani, Regional Perfecture of Larisa
Principal Investigator: Demetra Zambouka, GP Medical State Center of Agioi Anargyri, Regional Perfecture of Larisa
Principal Investigator: Charalampos Terzopoulos, MD, Orthopedics Private office, Zografou, Athens, Greece
Principal Investigator: John Sakellariou, MD, Pathology, Registrat A Medical Center of Farkadona, Thessalia, Greece
Principal Investigator: Aglaia Roganaki, MD, Registrat B, Peripheral Medical Center of Mitropolis, Thessalia, Greece
Principal Investigator: Vasilis Delezos, MD, Registrat B Medical Center of Sophades, Thessalia, Greece
Principal Investigator: Victoria Katsouri, MD, Registrat B Medical Center of Sophades, Thessalia, Greece
Principal Investigator: Maria Papala, MD State Medical Center of Tyrnavos, Thessalia, Greece
Principal Investigator: Styliani Papakosta, MD, Phyciatry Medical Private Office, Larisa, Greece
Principal Investigator: Athanasios Tsivgoulis, MD in Physiatry Medical Diagnosis Center, Lesvos Island, Greece
Principal Investigator: Petros Prokopis, MD Medical Office of Avlona
Principal Investigator: George Papadimitriou, MD, Orthopedics Private Medical Office, Vari Attikis
Principal Investigator: Vasilios Hamos, MD, Director State Medical Cener, Agia, Larissa
Principal Investigator: Lemonia Arvanitakou, MD State Medical Center, Agia, Larissa
Principal Investigator: Victoria Rizou, MD State Medical Office, Halki, Larissa
Principal Investigator: Vassiliki Mamakou, MD, Internist Mytilini
Principal Investigator: Antonios Partsinevelos, MD, Orth Private Office, Marousi, Athens
Principal Investigator: George Patoulis, MD, Orth Private Office, Marousi, Athens
  More Information