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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00478569
First received: May 23, 2007
Last updated: May 8, 2013
Last verified: May 2013
  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:

  1. 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)
  2. 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
  3. to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.

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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

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 ]

Enrollment: 1179
Study Start Date: May 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Parathyroid Hormone (PTH) (1-84) Drug: Parathyroid Hormone (PTH) (1-84)
Adherence to PTH(1-84) treatment in Usual Clinical Settings
Other Name: Preotact

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00478569     History of Changes
Other Study ID Numbers: FP-002-IM
Study First Received: May 23, 2007
Last Updated: May 8, 2013
Health Authority: Austria: Ethikkommission
Denmark: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Ireland:
Netherlands:
Spain: Ethics Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014