Adherence to PTH(1-84) Treatment (FP-002-IM) - Full Text View

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00478569

Purpose

The primary objective is:

1) to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting.

The secondary objectives are:

to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH(1-84)
to describe (using available data) the long term treatment effectiveness during the 24 months following initiation of PTH(1-84) treatment in a normal clinical setting
to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.

Condition	Intervention	Phase
Clinical Use of PTH(1-84)	Drug: Parathyroid Hormone (PTH) (1-84)	Phase IV

Drug Information available for: Parathyroid

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Adherence to PTH(1-84) Treatment in Europe. A Non-Interventional Cohort Study Collecting Safety Information and Examining Reasons and Predictors for Adherence to PTH(1-84) Treatment in Usual Clinical Settings

Further study details as provided by Nycomed:

Primary Outcome Measures:

To describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Describe demographics and clinical characteristics of patients that in a normal clinical setting are started on a treatment regimen with PTH(1-84) To describe (using available data) the long term treatment effectiveness during the 24 months fo [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2012
Study Start Date:	May 2007
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Adherence to PTH(1-84) treatment in Usual Clinical Settings

Eligibility

Study Population

Patients with osteoporosis

Criteria

Inclusion Criteria:

According to the current SmPC (17)
PTH(1-84) treatment initiated within one month preceding enrolment
The patient's written informed consent to direct access and data processing must be obtained.

Exclusion Criteria:

According to the current SmPC (17)
The patient cannot participate in a clinical trial with PTH (all other trials allowed).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478569

Contacts

Contact: Clinical Trial Operations

+45 4677 1111

Locations

Denmark
Nycomed	Recruiting
Roskilde, Denmark, 4000
Contact: Clinical Trial Operations +45 4677 1111 clinicaltrials@nycomed.com

Sponsors and Collaborators

Nycomed

Investigators

Study Chair:

Nycomed Clinical Trial Operations

Headquaters

More Information

Responsible Party:	Nycomed ( Nycomed )
Study ID Numbers:	FP-002-IM
Study First Received:	May 23, 2007
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00478569
Health Authority:	Austria: Ethikkommission; Czech Republic: State Institute for Drug Control; Denmark: Ethics Committee; France: Institutional Ethical Committee; Greece: Ethics Committee; Italy: Ethics Committee; Spain: Ethics Committee; Switzerland: Ethikkommission; United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on January 16, 2009