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

May 4, 2012 updated by: Nycomed

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cities in Germany, Germany
        • Nycomed Deutschland GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with severe postmenopausal osteoporosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nycomed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 13, 2007

First Posted (Estimate)

August 14, 2007

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP-004-DE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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