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

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ClinicalTrials.gov Identifier: NCT00515593
Recruitment Status : Completed
First Posted : August 14, 2007
Last Update Posted : May 7, 2012
Sponsor:
Information provided by:
Nycomed

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)

Condition or disease Intervention/treatment
Postmenopause Osteoporosis Drug: Parathyroid hormone (PTH) (Preotact)

Study Type : Observational
Actual Enrollment : 110 participants
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
Study Start Date : September 2006
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources


Intervention Details:
    Drug: Parathyroid hormone (PTH) (Preotact)
    Patients with severe postmenopausal osteoporosis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515593


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

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
First Posted: August 14, 2007    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012

Keywords provided by Nycomed:
osteoporosis
postmenopausal women
Severe postmenopausal osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs