Clinical trial NCT01652690: Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
Official title: Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: One Amgen Center Drive
name: THOUSAND OAKS
name: CA
name: 91320-1799
name: USA
First posted: 2012-07-30
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
timeFrame: 24 months
measure: Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
timeFrame: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
measure: Number of Participants Receiving All Prescriptions and Injections of Denosumab
timeFrame: Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
measure: Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
timeFrame: 24 months
measure: Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
timeFrame: Baseline (day 1)
measure: Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
timeFrame: Month 6
measure: Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
timeFrame: Month 12
measure: Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
timeFrame: Month 18
measure: Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
timeFrame: Month 24
measure: Number of Denosumab Post-baseline Injections Received by Each Participant
timeFrame: 24 months
measure: Number of Participants Having Radiologic Bone Assessments
timeFrame: Pre-baseline (before first denosumab injection) and during the study (post-baseline)
measure: Number of Participants Having Osteoporosis Related Laboratory Examinations
timeFrame: Pre-baseline (before first denosumab injection) and post-baseline
Secondary outcomes:
measure: Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
timeFrame: 24 months
measure: Number of Participants With Serious ADRs to Denosumab
timeFrame: 24 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Ceske Budejovice
country: Czechia
facility: Research Site
city: Havlickuv Brod
country: Czechia
facility: Research Site
city: Karlovy Vary
country: Czechia
facility: Research Site
city: Kutna Hora
country: Czechia
facility: Research Site
city: Ostrava-Trebovice
country: Czechia
facility: Research Site
city: Ostrava
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 11
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 4 - Nusle
country: Czechia
facility: Research Site
city: Trutnov
country: Czechia
facility: Research Site
city: Vsetin
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Osteocentrum Zlin
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Humenne
country: Slovakia
facility: Research Site
city: Kosice-Saca
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Lubochna
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Martin
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.