Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT00515593
Status:
COMPLETED
Last Update Posted:
2012-05-07
First Post:
2007-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)
Sponsor:
Nycomed
Organization:
Study Overview
Official Title:
Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: