Clinical Use of PTH(1-84)NCT00478569
Adherence to PTH(1-84) Treatment (FP-002-IM)
An observational study of Clinical Use of PTH(1-84), run by Takeda at 1 site in Denmark.
Trial summary
The primary objective is: 1) to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting. The secondary objectives are: 1. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Clinical Use of PTH(1-84)
- What is being tested?
- Parathyroid Hormone (PTH) (1-84)
- How many people
- 1,179 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2007to Mar 2013
- 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: Postmenopausal women with osteoporosis and a high risk of fractures prescribed PTH(1-84) in a normal clinical setting.
Who may be able to join
- According to the current Summary of Product Characteristics (SmPC)
- PTH(1-84) treatment initiated within one month preceding enrolment
- The patient's written informed consent to direct access and data processing must be obtained.
Who cannot join
- According to the current SmPC
- The patient cannot participate in a clinical trial with PTH (all other trials allowed).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence to PTH(1-84) Treatment in Europe. A Non-interventional Cohort Study Collecting Safety Information and Examining Reasons and Predictors for Adherence to PTH(1-84) Treatment in Usual Clinical Settings
The primary objective is:
- to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting.
The secondary objectives are:
- to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH(1-84)
- to describe (using available data) the long term treatment effectiveness during the 24 months following initiation of PTH(1-84) treatment in a normal clinical setting
- to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.
- Conditions
- Clinical Use of PTH(1-84)
- Being tested
- Parathyroid Hormone (PTH) (1-84)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parathyroid Hormone (PTH) (1-84)Drug
Also called Preotact
Adherence to PTH(1-84) treatment in Usual Clinical Settings
| Study group | Role | What they receive |
|---|---|---|
| Parathyroid Hormone (PTH) (1-84) | PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months. Receives: Drug: Parathyroid Hormone (PTH) (1-84) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Discontinued Before 6 Months of Treatment
A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards.
Measured: 6 months
Secondary outcomes (3)
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment
A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards. A participant was defined as "temporarily discontinued" if treatment with PTH(1-84) was not ongoing at the time point but was then ongoing at a future time point. This was the case when a participant or investigator wanted to pause the treatment for a length of time (e.g. because of an adverse event or interruption). Therefore, a participant was defined as still "ongoing" during the trial if treatment with PTH(1-84) had not been permanently or temporarily discontinued at that time point. A participant was only defined as "missing" or "unknown" if they attended the relevant visit and there was no result or "unknown" was entered as the result. Results for months 3, 12, 18 and 24 are cumulative data up until that time point.
Measured: From enrollment to 3, 12, 18, and 24 months
Duration of Treatment
Duration of treatment was defined as the last known date that PTH(1-84) was taken minus the first date that PTH(1-84) was taken plus one. In the calculation of duration, no adjustment was made for the prescribed dose frequency or for periods of temporary discontinuation due to adverse drug reactions (ADRs) or temporary patient suspension of treatment.
Measured: 24 months
Treatment Compliance by Visit
A participant was defined as compliant if the participant took the treatment as prescribed by the Physician, i.e. complied with the Physician's advice and followed the treatment regimen prescribed. A participant whose dose frequency and treatment length were changed during treatment, e.g. in response to a raised serum calcium level, was regarded as fully compliant if the revised treatment regimen was adhered to.
Data on compliance were obtained at each visit and relate to the period since the previous recorded visit.
Measured: From enrollment to 3, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startApr 2007
- Primary completionMar 2013
- Study completionMar 2013
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.
- Other trials for Clinical Use of PTH(1-84)Studies of the same condition, open and under way.
- More trials run by TakedaThe 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
- 1,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478569
- Sponsor's protocol ID
- FP-002-IM
- Status last verified
- Apr 2014
- First submitted
- 23 May 2007
- Last updated
- 28 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to PTH(1-84) Treatment in Europe. A Non-interventional Cohort Study Collecting Safety Information and Examining Reasons and Predictors for Adherence to PTH(1-84) Treatment in Usual Clinical Settings
- ClinicalTrials.gov ID
- NCT00478569
- Acronym / sponsor ID
- FP-002-IM
- Conditions
- Clinical Use of PTH(1-84)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,179 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 May 2007 (estimated)
- Results
- Posted 28 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is:
- to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting.
The secondary objectives are:
- to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH(1-84)
- to describe (using available data) the long term treatment effectiveness during the 24 months following initiation of PTH(1-84) treatment in a normal clinical setting
- to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parathyroid Hormone (PTH) (1-84) | – | Drug: Parathyroid Hormone (PTH) (1-84)PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal women with osteoporosis and a high risk of fractures prescribed PTH(1-84) in a normal clinical setting.
Key inclusion criteria (3 listed)
- According to the current Summary of Product Characteristics (SmPC)
- PTH(1-84) treatment initiated within one month preceding enrolment
- The patient's written informed consent to direct access and data processing must be obtained.
Key exclusion criteria (2 listed)
- According to the current SmPC
- The patient cannot participate in a clinical trial with PTH (all other trials allowed).
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 |
|---|---|---|
| Parathyroid Hormone (PTH) (1-84)Also: PreotactAdherence to PTH(1-84) treatment in Usual Clinical Settings | Drug | Parathyroid Hormone (PTH) (1-84) |
Primary outcome
Number of Participants Who Discontinued Before 6 Months of Treatment
Time frame: 6 months
A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards.
3 secondary outcomes
Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment
Time frame: From enrollment to 3, 12, 18, and 24 months
Duration of Treatment
Time frame: 24 months
Treatment Compliance by Visit
Time frame: From enrollment to 3, 6, 12, 18, and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Medical Director, Clinical Science study director
Takeda
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 Clinical Use of PTH(1-84), run by Takeda at 1 site in Denmark.
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 2 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 28 May 2014. 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 Denmark. 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 28 May 2014). 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 Who Discontinued Before 6 Months of Treatment (time frame: 6 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 28 May 2014.