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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Female

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)

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nycomed
• Treatments: Hormones; Parathyroid Hormone

Criteria

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.