PostmenopauseNCT00515593
PROPOSE Quality - PReOtact in Postmenopausal OStEoporosis - Quality of Life Study (FP-004-DE)
An observational study of Postmenopause and Osteoporosis, run by Nycomed at 1 site in Germany.
Trial summary
The objectives of the study are to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire) pain assessment at the beginning of the Preotact® treatment and at the end of the observational period (VAS score) to describe bone mineral… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postmenopause, Osteoporosis
- What is being tested?
- Parathyroid hormone (PTH) (Preotact)
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Jul 2008
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe postmenopausal osteoporosis
Who may be able to join
- Inclusion requires that Preotact® is prescribed in accordance with the SPC and that the stated contraindications are strictly considered.
- Caution should be taken by the treating Physician concerning any precautions, warnings and potential drug interactions stated in the SPC.
- No further inclusion or exclusion parameters are defined. The decision for the individual application of Preotact® will be strictly made by the physicians.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis
The objectives of the study are
- to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire)
- pain assessment at the beginning of the Preotact® treatment and at the end of the observational period (VAS score)
- to describe bone mineral density at the beginning of the Preotact® treatment and at the end of the observational period (T-Score)
- to describe incidence of bone fractures caused by osteoporosis as well as of other pathological findings of the skeleton after the beginning of the Preotact® treatment
- to describe serum level of calcium and the bone resorption marker desoxypyridinoline (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the beginning of the Preotact® treatment and at the end of the observational period (only in subgroup of patients, where the physician sees a need to measure these parameters)
- to document all adverse drug reactions after the beginning of the Preotact® treatment
- the analysis of subgroups with different risk for bone fractures caused by osteoporosis at the beginning of the Preotact® treatment
- to assess the manageability and functioning of the Pen system for injection of Preotact® (self administered questionnaire)
- Conditions
- Postmenopause, Osteoporosis
- Being tested
- Parathyroid hormone (PTH) (Preotact)
- Keywords
- osteoporosis, postmenopausal women, Severe postmenopausal osteoporosis
- Medical subject headings
- Osteoporosis, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parathyroid hormone (PTH) (Preotact)Drug
Patients with severe postmenopausal osteoporosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startSep 2006
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PostmenopauseStudies of the same condition, open and under way.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nycomed Clinical Trial Operations, Study chair, Headquaters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515593
- Sponsor's protocol ID
- FP-004-DE
- Status last verified
- May 2012
- First submitted
- 13 Aug 2007
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moricke R, Rettig K, Bethke TD. Use of recombinant human parathyroid hormone(1-84) in patients with postmenopausal osteoporosis: a prospective, open-label, single-arm, multicentre, observational cohort study of the effects of treatment on quality of life and pain--the PROPOSE study. Clin Drug Investig. 2011;31(2):87-99. doi: 10.2165/11538880-000000000-00000.
PubMed 21155613
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT00515593
- Acronym / sponsor ID
- FP-004-DE
- Conditions
- Postmenopause, Osteoporosis
- Keywords
- osteoporosis, postmenopausal women, Severe postmenopausal osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Aug 2007 (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 objectives of the study are
- to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire)
- pain assessment at the beginning of the Preotact® treatment and at the end of the observational period (VAS score)
- to describe bone mineral density at the beginning of the Preotact® treatment and at the end of the observational period (T-Score)
- to describe incidence of bone fractures caused by osteoporosis as well as of other pathological findings of the skeleton after the beginning of the Preotact® treatment
- to describe serum level of calcium and the bone resorption marker desoxypyridinoline (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the beginning of the Preotact® treatment and at the end of the observational period (only in subgroup of patients, where the physician sees a need to measure these parameters)
- to document all adverse drug reactions after the beginning of the Preotact® treatment
- the analysis of subgroups with different risk for bone fractures caused by osteoporosis at the beginning of the Preotact® treatment
- to assess the manageability and functioning of the Pen system for injection of Preotact® (self administered questionnaire)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe postmenopausal osteoporosis
Key inclusion criteria (3 listed)
- Inclusion requires that Preotact® is prescribed in accordance with the SPC and that the stated contraindications are strictly considered.
- Caution should be taken by the treating Physician concerning any precautions, warnings and potential drug interactions stated in the SPC.
- No further inclusion or exclusion parameters are defined. The decision for the individual application of Preotact® will be strictly made by the physicians.
Key exclusion criteria (0 listed)
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) (Preotact)Patients with severe postmenopausal osteoporosis | Drug | – |
Primary outcome
Not reported in the source record.
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 7 May 2012.
- Derived from this study: PubMed 21155613Moricke R, Rettig K, Bethke TD. Use of recombinant human parathyroid hormone(1-84) in patients with postmenopausal osteoporosis: a prospective, open-label, single-arm, multicentre, observational cohort study of the effects of treatment on quality of life and pain--the PROPOSE study. Clin Drug Investig. 2011;31(2):87-99. doi: 10.2165/11538880-000000000-00000.
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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.
Nycomed Clinical Trial Operations study chair
Headquaters
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 Postmenopause and Osteoporosis, run by Nycomed at 1 site in Germany.
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 0 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 7 May 2012. 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 Germany. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00515593, 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 7 May 2012.