PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis... | NCT00515593

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

NCT00515593

Sponsor

Nycomed

Status

Completed

Last Update Posted

May 7, 2012Estimated

Enrollment

110Actual

Phase

Not provided

Conditions

Postmenopause
Osteoporosis

Interventions

Parathyroid hormone (PTH) (Preotact)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Jul 2008Actual

First Submitted Date

Aug 13, 2007

First Submission Date that Met QC Criteria

Aug 13, 2007

First Posted Date

Aug 14, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2012

Last Update Posted Date

May 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Parathyroid hormone (PTH) (Preotact)	Drug	Patients with severe postmenopausal osteoporosis

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with severe postmenopausal osteoporosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nycomed Clinical Trial Operations	Headquaters	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nycomed Deutschland GmbH		Cities in Germany			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21155613	Derived	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.

ID	Term
D010024	Osteoporosis
D015663	Osteoporosis, Postmenopausal

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

ID	Term
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides