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

NCT ID: NCT00515593

Last Updated: 2012-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-07-31

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Parathyroid hormone (PTH) (Preotact)

Patients with severe postmenopausal osteoporosis

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nycomed

INDUSTRY

Sponsor Role: lead

Responsible Party

Nycomed

Principal Investigators

Nycomed Clinical Trial Operations

Role: STUDY_CHAIR

Headquaters

Locations

Nycomed Deutschland GmbH

Cities in Germany, , Germany

Countries

Germany

References

Moricke R, Rettig K, Bethke TD. Use of recombinant human parathyroid hormone(1-84) in patients with postmenopausal osteoporosis: a prospective, open-label, single-arm, multicentre, observational cohort study of the effects of treatment on quality of life and pain--the PROPOSE study. Clin Drug Investig. 2011;31(2):87-99. doi: 10.2165/11538880-000000000-00000.

Reference Type: DERIVED

PMID: 21155613 (View on PubMed)

Other Identifiers

FP-004-DE

Identifier Type: -

Identifier Source: org_study_id