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

Purpose

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)

Condition	Intervention
Postmenopause Osteoporosis	Drug: Parathyroid hormone (PTH) (Preotact)

MedlinePlus related topics:

Osteoporosis

Drug Information available for:

Parathyroid

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

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

Further study details as provided by Nycomed:

Biospecimen Retention: None Retained

Biospecimen Description:

Intervention Details:

Patients with severe postmenopausal osteoporosis

Eligibility

Study Population

Patients with severe postmenopausal osteoporosis

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515593

Locations

Sponsors and Collaborators

Nycomed

Investigators


Study Chair:	Nycomed Clinical Trial Operations	Headquaters

More Information

Responsible Party:	Nycomed ( Nycomed )
Study ID Numbers:	FP-004-DE
First Received:	August 13, 2007
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00515593
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:

osteoporosis

postmenopausal women

Severe postmenopausal osteoporosis

Study placed in the following topic categories:

Musculoskeletal Diseases

Osteoporosis, Postmenopausal

Quality of Life

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

ClinicalTrials.gov processed this record on October 28, 2008

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00515593