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

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

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.

Study Overview

• Status: Completed
• Conditions: Clinical Use of PTH(1-84)
• Intervention / Treatment: Drug: Parathyroid Hormone (PTH) (1-84)

• Study Type: Observational
• Enrollment (Actual): 1179

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Nycomed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Preotact

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Discontinued Before 6 Months of Treatment	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment	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.	From enrollment to 3, 12, 18, and 24 months
Duration of Treatment	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.	24 months
Treatment Compliance by Visit	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.	From enrollment to 3, 6, 12, 18, and 24 months

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: May 23, 2007
• First Submitted That Met QC Criteria: May 23, 2007
• First Posted (Estimate): May 25, 2007

Study Record Updates

• Last Update Posted (Estimate): May 28, 2014
• Last Update Submitted That Met QC Criteria: April 29, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Calcium-Regulating Hormones and Agents; Hormones; Parathyroid Hormone
• Other Study ID Numbers: FP-002-IM