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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00515593
First received: August 13, 2007
Last updated: May 4, 2012
Last verified: May 2012
  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)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis

Resource links provided by NLM:


Further study details as provided by Nycomed:

Enrollment: 110
Study Start Date: September 2006
Study Completion Date: July 2008
Intervention Details:
    Drug: Parathyroid hormone (PTH) (Preotact)
    Patients with severe postmenopausal osteoporosis
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Nycomed Deutschland GmbH
Cities in Germany, Germany
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

No publications provided by Nycomed

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00515593     History of Changes
Other Study ID Numbers: FP-004-DE
Study First Received: August 13, 2007
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:
osteoporosis
postmenopausal women
Severe postmenopausal osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 30, 2014