Osteoporosis is a systemic skeletal disorder characterized by low bone mineral density and micro-architectural deterioration of bone tissue, by which bones become brittle and therefore are at greater risk of fracture even when exposed to minimal trauma. Fractures are the most significant clinical event in osteoporosis, affecting most frequently the wrist, vertebrae and femur. In the case of fractures of the femur, hospitalization is essential and, in most cases, surgery with the insertion of prosthetic implants is required. Epidemiological data evidences that only 50% of patients remain self-sufficient after a fracture of the femur and that quality of later life is, in any case, degraded. The consequences of vertebral fractures are less dramatic but, especially if two or more vertebrae are affected, may lead to chronic pain, reduced motility, kyphosis (forward bending of the spine), loss of height and difficulty breathing. The significance of osteoporosis also derives from its ever high incidence, as increases in life expectancy over the last few decades have increased the number of people at risk of osteoporosis and the resultant fractures, with the trend seemingly inexorably on the rise. According to data from the World Health Organization (WHO), in 1990 there were only approximately 1.7 million femur fractures worldwide, with as many as 6.3 million expected in the year 2050. These numbers require increased attention by health organizations in identifying individuals at risk and the most suitable therapies, but also individual participation concerning especially prevention.

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Italian Legislative Decree No. 46 of 24th February 1997, Article 21
1. It is prohibited to advertise to the general public devices that, according to regulations adopted by Ministry of Health decree, may only be sold on prescription or be employed under the supervision of a doctor or other healthcare professional.
2. Advertising to the general public of devices other than those referred to in paragraph 1 are subject to authorization by the Ministry of Health. Opinions on applications for authorization are expressed by the Commission of Experts provided for in Article 6, paragraph 3, of Legislative Decree No. 541 of 30th December 1992, and comprising a representative of the Department of the Ministry of Health responsible for medical devices and a representative of the Ministry of Industry, Trade and Commerce.

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