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

NCT00478569 | Completed Results DMC

• 1 other identifier: FP-002-IM
• Study Type: observational
• Target: 1,179
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.

Conditions

Clinical Use of PTH(1-84)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment

  From enrollment to 3, 12, 18, and 24 months

• Duration of Treatment

  24 months

• Treatment Compliance by Visit

  From enrollment to 3, 6, 12, 18, and 24 months

Study Arms (1)

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)

Interventions

Parathyroid Hormone (PTH) (1-84) DRUG

Adherence to PTH(1-84) treatment in Usual Clinical Settings

Also known as: Preotact

Parathyroid Hormone (PTH) (1-84)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Nycomed

Roskilde, 4000, Denmark

Location

MeSH Terms

Interventions

Parathyroid Hormone

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director, Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 25, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 28, 2014
• Results First Posted: May 28, 2014

Record last verified: 2014-04

Locations

DK (1)