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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00515593
Enrollment
110
Registered
2007-08-14
Start date
2006-09-30
Completion date
2008-07-31
Last updated
2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopause

Keywords

osteoporosis, postmenopausal women, Severe postmenopausal osteoporosis

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)

Interventions

DRUGParathyroid hormone (PTH) (Preotact)

Patients with severe postmenopausal osteoporosis

Sponsors

Nycomed
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026