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: April 29, 2014
Last verified: April 2014
  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:
  • Number of Participants Who Discontinued Before 6 Months of Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards.


Secondary Outcome Measures:
  • Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment [ Time Frame: From enrollment to 3, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as "temporarily discontinued" if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still "ongoing" during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as "missing" or "unknown" if they attended the relevant visit and there was no result or "unknown" was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.

  • Duration of Treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.

  • Treatment Compliance by Visit [ Time Frame: From enrollment to 3, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

    A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician's advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to.

    Data on compliance were obtained at each visit and relate to the period since the previous recorded visit.



Enrollment: 1179
Study Start Date: April 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)
PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
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

Postmenopausal women with osteoporosis and a high risk of fractures prescribed PTH(1-84) in a normal clinical setting.

Criteria

Inclusion Criteria:

  • According to the current Summary of Product Characteristics (SmPC)
  • 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
  • The patient cannot participate in a clinical trial with PTH (all other trials allowed).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director, Clinical Science Takeda
  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
Results First Received: April 29, 2014
Last Updated: April 29, 2014
Health Authority: Austria: Ethikkommission
Denmark: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Ireland: Ethics Committee
Netherlands: N/A
Spain: Ethics Committee
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on October 23, 2014