OsteoporosisNCT00365924
A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo
A study testing Forteo in people with Osteoporosis, run by Pfizer at 3 sites in Argentina.
Trial summary
This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo. Read more about this study
- Who is it for?
- Ages 55 to 70 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Forteo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesArgentina
- Study dates
- Dec 2006to Apr 2008
- Phase
- Interventional
- 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 55 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women with osteoporosis
Who cannot join
- Any therapies or products affecting bone turnover within 12 months of Screening.
- Bisphosphonate treatment >1 month in total duration at any time in the past.
- In addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to Screening.
Trial locations and contacts
3 sites in 1 country.
Argentina3 sites
Pfizer Investigational Site
Buenos Aires, C1055AAK
Pfizer Investigational Site
Buenos Aires, C1428AQK
Pfizer Investigational Site
Capital Federal - Buenos Aires, C1012AAP
About this study
Official title: A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)
This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo.
- Conditions
- Osteoporosis
- Being tested
- Forteo
- Keywords
- 12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForteoDrug
Also called Recombinant Human PTH 1-34
Open label single arm study with Forteo as an intervention
| Study group | Role | What they receive |
|---|---|---|
| Forteo | Other | Not described Receives: Drug: Forteo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo
Measured: 12 months
Secondary outcomes (1)
Changes in BMD and bone biomarkers following 12 months of therapy with Forteo
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startDec 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365924
- Sponsor's protocol ID
- A9001294
- Status last verified
- Jun 2008
- First submitted
- 16 Aug 2006
- Last updated
- 23 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Recombinant Human Parathyroid Hormone, PTH (Forteo)
- ClinicalTrials.gov ID
- NCT00365924
- Acronym / sponsor ID
- A9001294
- Conditions
- Osteoporosis
- Keywords
- 12 month therapy with postmenopausal women with osteoporosis to examine changes in bone quality parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Aug 2006 (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.
This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Forteo | Other | Drug: Forteo |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women with osteoporosis
Key exclusion criteria (3 listed)
- Any therapies or products affecting bone turnover within 12 months of Screening.
- Bisphosphonate treatment >1 month in total duration at any time in the past.
- In addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to Screening.
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 |
|---|---|---|
| ForteoAlso: Recombinant Human PTH 1-34Open label single arm study with Forteo as an intervention | Drug | Forteo |
Primary outcome
Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo
Time frame: 12 months
1 secondary outcome
Changes in BMD and bone biomarkers following 12 months of therapy with Forteo
Time frame: 12 months
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 23 Mar 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forteo in people with Osteoporosis, run by Pfizer at 3 sites in Argentina.
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 1 inclusion and 3 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 23 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Argentina. 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?
Changes in bone quality parameters (micro- and macroarchitecture) in osteoporotic postmenopausal women following 12 months of therapy with Forteo (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 23 Mar 2009.