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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515593
• Other study ID #: FP-004-DE
• Status: Completed
• Phase: N/A
• First received: August 13, 2007
• Last updated: May 4, 2012
• Start date: September 2006
• Est. completion date: July 2008

Study information

• Verified date: May 2012
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopause

Intervention

Drug:
• Parathyroid hormone (PTH) (Preotact)
Patients with severe postmenopausal osteoporosis

Locations

Country	Name	City	State
Germany	Nycomed Deutschland GmbH	Cities in Germany

Sponsors (1)

Lead Sponsor	Collaborator
Nycomed

Country where clinical trial is conducted

Germany,