Osteoporosis Screening Trial

Completed

• Conditions: Osteoporosis

• Registration Number: NCT01677637
• Lead Sponsor: Elpen Pharmaceutical Co. Inc.

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-09-03
• Status Verified: 2013-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Osteoporosis Indicator	1 year	T-score per female as measured by Holofic Sahara Instrument

Trial Locations

Locations (1)

Iaso Hospital of Athens, Center of Endocrinology and Bone Metabolism; 🇬🇷 Athens, Kifisias Avenue, 37-39, Maroussi, Greece