PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)

Completed

• Conditions: Osteoporosis; Postmenopause

• Registration Number: NCT00515593
• Lead Sponsor: Nycomed

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-08-13
• Study First Submitted QC: 2007-08-13
• Study First Posted: 2007-08-14
• Study Completion: 2008-07
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Inclusion requires that Preotact® is prescribed in accordance with the SPC and that the stated contraindications are strictly considered.
• Caution should be taken by the treating Physician concerning any precautions, warnings and potential drug interactions stated in the SPC.
• No further inclusion or exclusion parameters are defined. The decision for the individual application of Preotact® will be strictly made by the physicians.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Nycomed Deutschland GmbH; 🇩🇪 Cities in Germany, Germany