Clinical trial NCT00515593: PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)
Official title: Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopause
Osteoporosis
Keywords: osteoporosis
postmenopausal women
Severe postmenopausal osteoporosis
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2007-08-14
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with 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)


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cities in Germany
country: Germany
facility: Nycomed Deutschland GmbH
Study officials:
affiliation: Headquaters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References:
citation: Moricke R, Rettig K, Bethke TD. Use of recombinant human parathyroid hormone(1-84) in patients with postmenopausal osteoporosis: a prospective, open-label, single-arm, multicentre, observational cohort study of the effects of treatment on quality of life and pain--the PROPOSE study. Clin Drug Investig. 2011;31(2):87-99. doi: 10.2165/11538880-000000000-00000.