Osteoporosis Clinical Trial
Official title:
Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis
The objectives of the study are
- to describe the quality of life at the beginning of the Preotact® treatment and at the
end of the observational period (Qualeffo-41 questionnaire)
- pain assessment at the beginning of the Preotact® treatment and at the end of the
observational period (VAS score)
- to describe bone mineral density at the beginning of the Preotact® treatment and at the
end of the observational period (T-Score)
- to describe incidence of bone fractures caused by osteoporosis as well as of other
pathological findings of the skeleton after the beginning of the Preotact® treatment
- to describe serum level of calcium and the bone resorption marker desoxypyridinoline
(DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the
beginning of the Preotact® treatment and at the end of the observational period (only
in subgroup of patients, where the physician sees a need to measure these parameters)
- to document all adverse drug reactions after the beginning of the Preotact® treatment
- the analysis of subgroups with different risk for bone fractures caused by osteoporosis
at the beginning of the Preotact® treatment
- to assess the manageability and functioning of the Pen system for injection of
Preotact® (self administered questionnaire)
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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