Osteoporosis, PostmenopausalNCT01652690

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

An observational study of Osteoporosis, Postmenopausal, run by Amgen at 29 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Osteoporosis, Postmenopausal
What is being tested?: Denosumab
Type of treatment: Injection or infusion
How many people: 600 participants
Where: 29 sitesin 2 countries
Study dates: 26 Jun 2012to 15 May 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

29 sites in 2 countries.

Country

City, postcode or hospital

29 sites in 2 countries

Czechia16 sites

Research Site
Brno, 602 00
Research Site
Brno, 638 00
Research Site
České Budějovice, 370 01
Research Site
Havlíčkův Brod, 580 22
Research Site
Karlovy Vary, 367 17
Research Site
Kutná Hora, 284 01
Research Site
Ostrava, 702 00
Research Site
Ostrava-Trebovice, 722 00
Research Site
Pilsen, 323 00
Research Site
Prague, 128 50
Research Site
Prague, 148 00
Research Site
Praha 4 - Nusle, 140 00
Research Site
Trutnov, 541 21
Research Site
Vsetín, 755 01
Research Site
Zlín, 760 01
Osteocentrum Zlin
Zlín

Other trials in Czechia

Slovakia13 sites

Research Site
Banská Bystrica, 974 01
Research Site
Bratislava, 826 06
Research Site
Bratislava, 833 05
Research Site
Humenné, 066 01
Research Site
Košice, 040 01
Research Site
Kosice-Saca, 040 15
Research Site
Ľubochňa, 034 91
Research Site
Lučenec, 984 01
Research Site
Martin, 036 01
Research Site
Nitra, 949 01
Research Site
Prešov, 080 01
Research Site
Trnava, 917 75
Research Site
Žilina, 010 01

Other trials in Slovakia

About this study

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

Conditions: Osteoporosis, Postmenopausal
Being tested: Denosumab
Medical subject headings: Osteoporosis, Postmenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01652690
Study group	Role	What they receive
Denosumab		Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia. Receives: Biological: Denosumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 months
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 24
Number of Denosumab Post-baseline Injections Received by Each Participant
Measured: 24 months
Number of Participants Having Radiologic Bone Assessments
Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
Measured: 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.
Measured: Pre-baseline (before first denosumab injection) and post-baseline

Secondary outcomes (2)

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).
Measured: 24 months
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.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 201215 May 2015

First posted30 Jul 2012 (estimated)
Study start26 Jun 2012
Primary completion15 May 2015
Study completion15 May 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01652690
Sponsor's protocol ID: 20110132
Status last verified: Mar 2019
First submitted: 26 Jul 2012
Last updated: 6 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 30191465

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis

All Osteoporosis, Postmenopausal trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice
ClinicalTrials.gov ID: NCT01652690
Acronym / sponsor ID: 20110132
Conditions: Osteoporosis, Postmenopausal
Study type: Observational
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Collaborators: One Amgen Center Drive, THOUSAND OAKS, CA, 91320-1799, USA
Study start: 26 Jun 2012 (actual)
Primary completion: 15 May 2015 (actual)
Study completion: 15 May 2015 (actual)
First posted: 30 Jul 2012 (estimated)
Results: Posted 26 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Denosumab	–	Biological: DenosumabPatients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DenosumabAlso: Prolia®This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.	Biological	Denosumab

Primary outcome

Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Time frame: 24 months
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.
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
Time frame: 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
Time frame: 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 whether or not the injections are given at the initial prescribing physician's office.
Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
Time frame: 24 months
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
Time frame: Baseline (day 1)
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.
Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
Time frame: Month 6
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.
Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
Time frame: Month 12
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.
Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
Time frame: Month 18
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.
Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
Time frame: Month 24
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.
Number of Denosumab Post-baseline Injections Received by Each Participant
Time frame: 24 months
Number of Participants Having Radiologic Bone Assessments
Time frame: Pre-baseline (before first denosumab injection) and during the study (post-baseline)
Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
Number of Participants Having Osteoporosis Related Laboratory Examinations
Time frame: Pre-baseline (before first denosumab injection) and post-baseline
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.

2 secondary outcomes

Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Time frame: 24 months
Number of Participants With Serious ADRs to Denosumab
Time frame: 24 months

Results and safety

Results posted to the registry on 26 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Czech Republic	300	265
Slovakia	300	279

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

Time frame: 24 months. Number. Unit: participants

Measure	Czech Republic n = 300	Slovakia n = 300
Value	295	296

Population analysed: Full analysis set (all enrolled patients who provided informed consent and received at least one injection)

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

Time frame: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively). Number. Unit: participants

Measure	Czech Republic n = 300	Slovakia n = 300
Baseline injection (n = 300, 300)	300	298
First post-baseline injection (n = 283, 293)	282	291
Second post-baseline injection (n = 276, 283)	275	282
Third post-baseline injection (n = 262, 276)	260	274
Fourth post-baseline injection (n = 246, 243)	245	240

Population analysed: Full analysis set; n = the number of participants who received the corresponding injection

Primary outcome: Number of Participants Receiving All Prescriptions and Injections of Denosumab

Time frame: Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively). Number. Unit: participants

Measure	Czech Republic n = 300	Slovakia n = 300
First post-baseline injection	283	293
Second post-baseline injection	276	283
Third post-baseline injection	262	276
Fourth post-baseline injection	246	243

Population analysed: Full analysis set

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

Time frame: 24 months. Number. Unit: participants

Measure	Czech Republic n = 35	Slovakia n = 21
Referred to other health care providers (total)	0	2
Referred to rheumatologist	0	2

Population analysed: Full analysis set participants who discontinued the study prematurely

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Czech Republic	0 of 300 (0%)	0 of 300 (0%)	Not reported
Slovakia	1 of 300 (0.3%)	0 of 300 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30191465Ruzickova 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Osteoporosis, Postmenopausal

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Active, not recruitingPhase 4
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Osteoporosis, Postmenopausal
RecruitingPhase 4
Combined Anabolic Therapy
Osteoporosis, Postmenopausal, Osteoporosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

29 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoporosis, Postmenopausal, run by Amgen at 29 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Czechia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office (time frame: 24 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01652690, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.