NCT02410044

Brief Summary

Evaluation of patient reported outcomes (PRO) / QoL regarding typical ailments in real-life patients with bone metastases treated with osteoprotective agents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 23, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

4.6 years

First QC Date

December 23, 2014

Last Update Submit

September 9, 2020

Conditions

Breast CancerProstate CancerBone Metastases

Keywords

Patient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

  • Patient Reported Outcomes (PRO) regarding bone pain and the impact of bone pain on quality of life and daily activities in patients with bone metastases treated with osteoprotective agents.

    12 months

Secondary Outcomes (1)

  • Patient Reported Outcomes regarding the impact of treatment on daily life

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastasized breast or prostate cancer at the start of first systemic osteoprotective treatment for bone metastases

You may qualify if:

  • Histologically confirmed metastatic breast or prostate cancer
  • Start of first systemic osteoprotective treatment
  • Ability to read and understand German
  • Written informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple sites all over Germany

Multiple Locations, Germany

Location

MeSH Terms

Conditions

Breast NeoplasmsProstatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Mark-Oliver Zahn, MD

    medical practise for oncology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2014

First Posted

April 7, 2015

Study Start

December 23, 2014

Primary Completion

August 16, 2019

Study Completion

August 16, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)