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

Osteoporosis Clinical Trial

Official title: Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis

Status Completed

Clinical Trial 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)

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopause

• NCT number: NCT00515593
• Study type: Observational
• Source: Nycomed
• Status: Completed
• Phase: N/A
• Start date: September 2006
• Completion date: July 2008