Nycomed Deutschland GmbH
Cities in Germany, Germany
NCT Number: NCT00515593
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)
Looking for future studies?
Notify Me18 year and older
Female
Observational
Cities in Germany, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with severe postmenopausal osteoporosis
Nycomed
Industry
Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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