Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00515593
Brief Summary:
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)
Study:
NCT00515593
Study Brief:
Protocol Section:
NCT00515593