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Completed

NCT Number: NCT00515593

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

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)

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Nycomed Deutschland GmbH

Cities in Germany, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parathyroid hormone (PTH) (Preotact)

Drug

Patients with severe postmenopausal osteoporosis

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2008
First posted
Aug 14, 2007
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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