Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice

NCT01652690 | Completed Results

• 1 other identifier: 20110132
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 29

Brief Summary

The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of these patients during the first 2 years of treatment. In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (12)

• Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office

  Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.

  24 months

• Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection

  Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)

• Number of Participants Receiving All Prescriptions and Injections of Denosumab

  Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.

  Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)

• Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care

  24 months

• Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection

  Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.

  Baseline (day 1)

• Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection

  Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.

  Month 6

• Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection

  Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.

  Month 12

• Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection

  Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.

  Month 18

• Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection

  Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.

  Month 24

• Number of Denosumab Post-baseline Injections Received by Each Participant

  24 months

• Number of Participants Having Radiologic Bone Assessments

  Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.

  Pre-baseline (before first denosumab injection) and during the study (post-baseline)

• Number of Participants Having Osteoporosis Related Laboratory Examinations

  Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.

  Pre-baseline (before first denosumab injection) and post-baseline

Secondary Outcomes (2)

• Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab

  24 months

• Number of Participants With Serious ADRs to Denosumab

  24 months

Study Arms (1)

Denosumab

Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.

Biological: Denosumab

Interventions

Denosumab BIOLOGICAL

This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.

Also known as: Prolia®

Denosumab

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

The study was conducted at various study centers in the Czech Republic and Slovakia. Postmenopausal women with osteoporosis who receive an injection of denosumab and meet the inclusion/exclusion criteria will be eligible to participate in the study.

You may qualify if:

• Women with a clinical diagnosis of postmenopausal osteoporosis
• Decision has been made to treat with denosumab 60 mg once every 6 months
• Have received their first injection of denosumab within 8 weeks prior to enrolling in this study.
• Appropriate written informed consent has been obtained (as required per local country regulations)

You may not qualify if:

• Participating in ongoing or have participated in previous denosumab clinical trials
• Participation in other clinical or device trials in the last 6 months
• Contra-indicated for treatment with Prolia® according to the approved applicable local product label.
• Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent

Sponsors & Collaborators

• Amgen: lead
• One Amgen Center Drive: collaborator
• THOUSAND OAKS: collaborator
• CA: collaborator
• 91320-1799: collaborator
• USA: collaborator

Study Sites (29)

Research Site

Brno, 602 00, Czechia

Location

Research Site

Brno, 638 00, Czechia

Location

Research Site

České Budějovice, 370 01, Czechia

Location

Research Site

Havlíčkův Brod, 580 22, Czechia

Location

Research Site

Karlovy Vary, 367 17, Czechia

Location

Research Site

Kutná Hora, 284 01, Czechia

Location

Research Site

Ostrava, 702 00, Czechia

Location

Research Site

Ostrava-Trebovice, 722 00, Czechia

Location

Research Site

Pilsen, 323 00, Czechia

Location

Research Site

Prague, 128 50, Czechia

Location

Research Site

Prague, 148 00, Czechia

Location

Research Site

Praha 4 - Nusle, 140 00, Czechia

Location

Research Site

Trutnov, 541 21, Czechia

Location

Research Site

Vsetín, 755 01, Czechia

Location

Research Site

Zlín, 760 01, Czechia

Location

Osteocentrum Zlin

Zlín, Czechia

Location

Research Site

Banská Bystrica, 974 01, Slovakia

Location

Research Site

Bratislava, 826 06, Slovakia

Location

Research Site

Bratislava, 833 05, Slovakia

Location

Research Site

Humenné, 066 01, Slovakia

Location

Research Site

Kosice-Saca, 040 15, Slovakia

Location

Research Site

Košice, 040 01, Slovakia

Location

Research Site

Lučenec, 984 01, Slovakia

Location

Research Site

Ľubochňa, 034 91, Slovakia

Location

Research Site

Martin, 036 01, Slovakia

Location

Research Site

Nitra, 949 01, Slovakia

Location

Research Site

Prešov, 080 01, Slovakia

Location

Research Site

Trnava, 917 75, Slovakia

Location

Research Site

Žilina, 010 01, Slovakia

Location

Related Publications (1)

• Ruzickova O, Killinger Z, Kasalicky P, Hamilton L, Tyl R, Tomkova S, Kalouche-Khalil L. Real-world Management of Women with Postmenopausal Osteoporosis Treated with Denosumab: A Prospective Observational Study in the Czech Republic and Slovakia. Adv Ther. 2018 Oct;35(10):1713-1728. doi: 10.1007/s12325-018-0779-9. Epub 2018 Sep 6.

  PMID: 30191465 BACKGROUND

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: June 26, 2012
• Primary Completion: May 15, 2015
• Study Completion: May 15, 2015
• Last Updated: March 6, 2019
• Results First Posted: May 26, 2016

Record last verified: 2019-03

Locations

CZ (16); SL (13)