NCT00515593

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Nycomed · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Postmenopause
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Parathyroid hormone (PTH) (Preotact)	Patients with severe postmenopausal osteoporosis

Timeline

• Start date: 2006-09-01
• Completion: 2008-07-01
• First posted: 2007-08-14
• Last updated: 2012-05-07

Locations

1 site across 1 country: Germany