Adherence to PTH(1-84) Treatment (FP-002-IM)
This study has been completed.
Sponsor:
Takeda Pharma A/S
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharma A/S )
ClinicalTrials.gov Identifier:
NCT00478569
First received: May 23, 2007
Last updated: May 8, 2013
Last verified: May 2013
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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 |
|---|---|
|
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 Global Research & Development Center, Inc.:
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 More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Takeda Pharma A/S ) |
| 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 May 19, 2013