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

Osteoporosis, Postmenopausal Clinical Trial

Official title:

Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652690
• Other study ID #: 20110132
• Status: Completed
• Start date: June 26, 2012
• Est. completion date: May 15, 2015

Study information

• Verified date: March 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 15, 2015
• Est. primary completion date: May 15, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

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

Locations

Country	Name	City	State
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Ceske Budejovice
Czechia	Research Site	Havlickuv Brod
Czechia	Research Site	Karlovy Vary
Czechia	Research Site	Kutna Hora
Czechia	Research Site	Ostrava
Czechia	Research Site	Ostrava-Trebovice
Czechia	Research Site	Plzen
Czechia	Research Site	Praha 11
Czechia	Research Site	Praha 2
Czechia	Research Site	Praha 4 - Nusle
Czechia	Research Site	Trutnov
Czechia	Research Site	Vsetin
Czechia	Osteocentrum Zlin	Zlin
Czechia	Research Site	Zlin
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Humenne
Slovakia	Research Site	Kosice
Slovakia	Research Site	Kosice-Saca
Slovakia	Research Site	Lubochna
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Martin
Slovakia	Research Site	Nitra
Slovakia	Research Site	Presov
Slovakia	Research Site	Trnava
Slovakia	Research Site	Zilina

Sponsors (6)

Lead Sponsor	Collaborator
Amgen	91320-1799, CA, One Amgen Center Drive, THOUSAND OAKS, USA

Countries where clinical trial is conducted

Czechia,  Slovakia, 

References & Publications (1)

Ružicková O, Killinger Z, Kasalický P, Hamilton L, Tyl R, Tomková 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care		24 months
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Denosumab Post-baseline Injections Received by Each Participant		24 months
Primary	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)
Primary	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	Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab	Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).	24 months
Secondary	Number of Participants With Serious ADRs to Denosumab	Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.	24 months

External Links

•   AmgenTrials clinical trials website