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

Overview

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)

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective

Interventions

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nycomed
  • Provider of Information About this Clinical Study
    • Nycomed, Nycomed
  • Overall Official(s)
    • Nycomed Clinical Trial Operations, Study Chair, Headquaters

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