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

Nycomed

Status: Completed

Conditions: Osteoporosis; Postmenopause

Treatments: Drug: Parathyroid hormone (PTH) (Preotact)

Study type: Observational

Funder types: Industry

Identifiers

NCT00515593

FP-004-DE

Details and patient eligibility

About

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)

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.