Trial record 13 of 943 for:    "Osteoporosis"

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
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 April 15, 2014