Post Menopausal OsteoporosisPILOTENCT02347865
Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
An observational study of Post Menopausal Osteoporosis, run by Amgen at 1 site in France.
Trial summary
The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France Read more about this study
- Who is it for?
- Ages 40 to 95 years, women only
- Conditions the study is for
- Post Menopausal Osteoporosis
- What is being tested?
- AMG 162 - Prolia
- How many people
- 777 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2015to 27 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: post menopausal women with osteoporosis, treated with Prolia
Who may be able to join
- post menopausal osteoporosis women in whom a decision has been made to treat with Prolia in the last 4 weeks
- received their first prescription of Prolia in the last 4 weeks
- patient has provided informed consent before enrolling in the study
Who cannot join
- patients participating in ongoing or previous Denosumab clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study to Describe Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France and Its Use in Routine Clinical Practice
The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France
Read the detailed description
This is a multicenter, observational and non-interventional study in PMO patients who receive Prolia® (60 mg subcutaneous [SC]) in France. Patients in the study will be enrolled in 2 waves, each targeting specific aspects of the overall study objectives. The first wave will enroll approximately 500 patients who will be followed for approximately 30 months from the first injection. Patients enrolled in this wave will provide descriptive data on persistence to Prolia® as well as a description of the characteristics of patients being prescribed Prolia®, information regarding Prolia® prescription and administration, procedures pertaining to Prolia® and safety.
The second wave will enroll approximately 250 patients and will only provide a cross-sectional description of the characteristics of patients being prescribed Prolia.
Around 2000 specialists in rheumatology and 9000 general practitioners will be randomly selected from a list of rheumatologists whether in hospital or private practice nationwide and a list of general practitioners managing patients with osteoporosis.
In all, 300 physicians initially interested to participate are expected, from which about 180 physicians will be qualified to participate. One-hundred and ten physicians will be initiated.
There are no procedures or changes to the routine clinical management of patients participating in the study. Baseline characteristics will be described for patients enrolling in both waves 1 and 2. Patients enrolling in wave 1 will be followed for approximately 30 months from the date of first injection in the study. It is anticipated that patients will return to the site. Clinical information obtained for routine clinical practice will be recorded where available, including Prolia administration, previous and current therapies, medical history (including fracture), ADRs, SADRs and co-morbidities.The study is descriptive in nature, and no formal hypothesis will be tested. In general, data summaries will be presented by wave and by subgroups of interest.
- Conditions
- Post Menopausal Osteoporosis
- Being tested
- AMG 162 - Prolia
- Keywords
- osteoporosis post menopausal women
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 162 - ProliaDrug
Also called denosumab
500 patients
AMG 162 - ProliaDrug
Also called denosumab
250 patients, one year later
| Study group | Role | What they receive |
|---|---|---|
| wave 1 | postmenopausal women with osteoporosis treated with Prolia Receives: Drug: AMG 162 - Prolia | |
| wave 2 | postmenopausal women with osteoporosis treated with Prolia Receives: Drug: AMG 162 - Prolia |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient occurence of persistence (persistence is defined in the outcome description) at 12 months
To evaluate the persistence with Prolia at 12 months in post menopausal women with osteoporosis (PMO) in France. To evaluate the persistence with Prolia at 24 months in PMO women in France. Patients will be defined as persistent with Prolia at 12 months if the patient receives at least 2 injections and the second injection at 6 months is no later than 6 months + 8 weeks (or 239 days) from the baseline injection
Measured: 12 months
Secondary outcomes (4)
patient occurence of persistence (persistence is defined in the outcome description) at 24 months and time to non-persistence at 24 months
To evaluate the persistence with Prolia at 24 months in PMO women in France. Patients will be defined as persistent with Prolia at 24 months if the patient receives at least 4 injections (including the baseline) and the time between any 2 injections is not more than 6 months + 8 weeks (or 239 days)
Measured: 24 months
describe the use of Prolia in routine clinical practice during approximately 30 months from the first injection
to describe the occurence of patients referred to another physician for follow up on prolia treatment, the number of injections received by the patient, the occurence of a patient receiving the first, second, third, fourth and fifth injections, the number of times a patient received Prolia injection by the prescriber and the number of times a patient received a Prolia injection outside the prescriber's office by nurse or other healthcare provider
Measured: 30 months from first injection
patient occurence of Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs) as collected in routine clinical practice
to describe the patient occurence of ADRs and SADRs as collected in routine clinical practice
Measured: 30 months or early termination
Occurrence of patient reported osteoporosis related vertebral and non vertebral fractures reported during the study
Patient occurence of osteoporosis related vertebral and non vertebral fractures during the study. Osteoporosis related fractures are defined as all fractures excluding skull, facial bones, mandible, metacarpus, finger phalanges, toe phalanges and cervical vertebrae and not associated with known high trauma severity or pathological fractures.
Measured: 30 months or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study start16 Jun 2015
- Primary completion26 Oct 2017
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Menopausal OsteoporosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347865
- Sponsor's protocol ID
- 20130240
- Acronym
- PILOTE
- Status last verified
- Nov 2022
- First submitted
- 13 Jan 2015
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Describe Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France and Its Use in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02347865
- Acronym / sponsor ID
- PILOTE / 20130240
- Conditions
- Post Menopausal Osteoporosis
- Keywords
- osteoporosis post menopausal women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 777 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with Prolia in France, and examine the use of Prolia in routine clinical practice in France
Detailed description
This is a multicenter, observational and non-interventional study in PMO patients who receive Prolia® (60 mg subcutaneous [SC]) in France. Patients in the study will be enrolled in 2 waves, each targeting specific aspects of the overall study objectives. The first wave will enroll approximately 500 patients who will be followed for approximately 30 months from the first injection. Patients enrolled in this wave will provide descriptive data on persistence to Prolia® as well as a description of the characteristics of patients being prescribed Prolia®, information regarding Prolia® prescription and administration, procedures pertaining to Prolia® and safety.
The second wave will enroll approximately 250 patients and will only provide a cross-sectional description of the characteristics of patients being prescribed Prolia.
Around 2000 specialists in rheumatology and 9000 general practitioners will be randomly selected from a list of rheumatologists whether in hospital or private practice nationwide and a list of general practitioners managing patients with osteoporosis.
In all, 300 physicians initially interested to participate are expected, from which about 180 physicians will be qualified to participate. One-hundred and ten physicians will be initiated.
There are no procedures or changes to the routine clinical management of patients participating in the study. Baseline characteristics will be described for patients enrolling in both waves 1 and 2. Patients enrolling in wave 1 will be followed for approximately 30 months from the date of first injection in the study. It is anticipated that patients will return to the site. Clinical information obtained for routine clinical practice will be recorded where available, including Prolia administration, previous and current therapies, medical history (including fracture), ADRs, SADRs and co-morbidities.The study is descriptive in nature, and no formal hypothesis will be tested. In general, data summaries will be presented by wave and by subgroups of interest.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wave 1 | – | Drug: AMG 162 - Proliapostmenopausal women with osteoporosis treated with Prolia |
| wave 2 | – | Drug: AMG 162 - Proliapostmenopausal women with osteoporosis treated with Prolia |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- post menopausal women with osteoporosis, treated with Prolia
Key inclusion criteria (3 listed)
- post menopausal osteoporosis women in whom a decision has been made to treat with Prolia in the last 4 weeks
- received their first prescription of Prolia in the last 4 weeks
- patient has provided informed consent before enrolling in the study
Key exclusion criteria (1 listed)
- patients participating in ongoing or previous Denosumab clinical trials
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 |
|---|---|---|
| AMG 162 - ProliaAlso: denosumab500 patients | Drug | wave 1 |
| AMG 162 - ProliaAlso: denosumab250 patients, one year later | Drug | wave 2 |
Primary outcome
patient occurence of persistence (persistence is defined in the outcome description) at 12 months
Time frame: 12 months
To evaluate the persistence with Prolia at 12 months in post menopausal women with osteoporosis (PMO) in France. To evaluate the persistence with Prolia at 24 months in PMO women in France. Patients will be defined as persistent with Prolia at 12 months if the patient receives at least 2 injections and the second injection at 6 months is no later than 6 months + 8 weeks (or 239 days) from the baseline injection
4 secondary outcomes
patient occurence of persistence (persistence is defined in the outcome description) at 24 months and time to non-persistence at 24 months
Time frame: 24 months
describe the use of Prolia in routine clinical practice during approximately 30 months from the first injection
Time frame: 30 months from first injection
patient occurence of Adverse Drug Reactions (ADRs) and Serious Adverse Drug Reactions (SADRs) as collected in routine clinical practice
Time frame: 30 months or early termination
Occurrence of patient reported osteoporosis related vertebral and non vertebral fractures reported during the study
Time frame: 30 months or early termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Related trials for Post Menopausal Osteoporosis
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Menopausal Osteoporosis, run by Amgen at 1 site in France.
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 3 inclusion and 1 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patient occurence of persistence (persistence is defined in the outcome description) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2022.