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

NCT00515593 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2012-05-07

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Parathyroid hormone (PTH) (Preotact)

Patients with severe postmenopausal osteoporosis

Sponsors & Collaborators

  • Nycomed

    lead INDUSTRY

Principal Investigators

  • Nycomed Clinical Trial Operations · Headquaters

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Completion
2008-07-31

Countries

  • Germany

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00515593 on ClinicalTrials.gov