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

Takeda

Status: Completed

Conditions: Clinical Use of PTH(1-84)

Treatments: Drug: Parathyroid Hormone (PTH) (1-84)

Study type: Observational

Funder types: Industry

Identifiers

NCT00478569

FP-002-IM

Details and patient eligibility

About

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.

Enrollment: 1,179 patients

Sex: Female

Volunteers: No Healthy Volunteers

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).

Trial design

1,179 participants in 1 patient group

Parathyroid Hormone (PTH) (1-84)

Description:

PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.

Treatment:

Drug: Parathyroid Hormone (PTH) (1-84)