PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)
This study has been completed.
Sponsor:
Nycomed: A Takeda Company
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00515593
First received: August 13, 2007
Last updated: May 4, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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)
| Condition | Intervention |
|---|---|
|
Postmenopause Osteoporosis |
Drug: Parathyroid hormone (PTH) (Preotact) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Parathyroid Hormone
U.S. FDA Resources
Further study details as provided by Nycomed: A Takeda Company:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with severe postmenopausal osteoporosis
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.
Contacts and Locations More Information
No publications provided by Nycomed: A Takeda Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Nycomed |
| ClinicalTrials.gov Identifier: | NCT00515593 History of Changes |
| Other Study ID Numbers: | FP-004-DE |
| Study First Received: | August 13, 2007 |
| Last Updated: | May 4, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Nycomed: A Takeda Company:
|
osteoporosis postmenopausal women Severe postmenopausal osteoporosis |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013