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

Completed

• Conditions: Clinical Use of PTH(1-84)
• Interventions: Drug: Parathyroid Hormone (PTH) (1-84)

• Registration Number: NCT00478569
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-23
• Study First Submitted QC: 2007-05-23
• Study First Posted: 2007-05-25
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-04
• Results First Submitted: 2014-04-29
• Results First Submitted QC: 2014-04-29
• Last Update Submitted: 2014-04-29
• Results First Posted: 2014-05-28
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1179

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parathyroid Hormone (PTH) (1-84)	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Discontinued Before 6 Months of Treatment	6 months	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

Name	Time	Method
Treatment Compliance by Visit	From enrollment to 3, 6, 12, 18, and 24 months	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.
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment	From enrollment to 3, 12, 18, and 24 months	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	24 months	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.

Trial Locations

Locations (1)

Nycomed; 🇩🇰 Roskilde, Denmark