Postmenopausal Women With Primary OsteoporosisPhase 4NCT00583518
STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)
A Phase 4 study testing Parathyroid hormone (PTH) in people with Postmenopausal Women With Primary Osteoporosis, run by Nycomed at 1 site in Denmark.
Trial summary
The primary objective of the study is to explore the relationship between a new image technology (ImaTx), that analyzes the trabecular structure of the bone using digitized radiographs and the bone mineral density (BMD) measured by Dual X-ray Absorptiometry (DXA) in the lumbar spine of postmenopausal (PM) women with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postmenopausal Women With Primary Osteoporosis
- What is being tested?
- Parathyroid hormone (PTH)
- How many people
- 129 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Feb 2012
- Phase
- Phase 4
- 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
Who may be able to join
- Has the subject given informed consent according to local requirements before any trial-related activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject.
- Is the subject a female?
- Is the subject 65 years old or above?
- Is the subject postmenopausal (more than 5 years), in the judgement of the investigator?
- Does the subject have primary osteoporosis, with a lumbar spine T score ≤ -3.0 SD, or a lumbar spine T-score ≤ -2.5 SD and previous fragility fracture[1], with a minimum of two evaluable lumbar vertebrae?
- Does the subject have a life expectancy of > 2 years?
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- Does the subject have a clinical indication to receive PTH(1-84) and is able to self-inject (or to have PTH(1-84) injection by a helper)?
- All inclusion criteria must be answered "yes" for a subject to participate in the trial.
- [1] Definition of fragility fracture in the scope of the study: Bone fractures that occur as a result of a fall from standing height or less. That is, fractures resulting from mechanical forces that would not ordinarily cause fractures in a healthy person.
Who cannot join
- Is the patient currently taking any of the following treatments: bisphosphonates, selective estrogen receptor modulators or hormone replacement therapy (if the patient discontinues any of these treatments at the screening visit, the question can be answered NO and the patient can be included)?
- Has the subject received, during her lifetime, strontium, fluoride or calcitonin > 3 months in total?
- Has the subject ever been treated with teriparatide or PTH(1-84)?
- Is the subject taking any other medication known to affect bone metabolism in the opinion of the investigator?
- Has the subject ever received radiation therapy to the skeleton?
- Has the subject ever been treated for a bone malignant disease?
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- Is the subject suffering from any known clinically significant diseases affecting calcium metabolism, including metabolic bone diseases such as hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia?
- Does the subject have any known history of hypersensitivity to parathyroid hormone or any of the excipients in the drug?
- Does the subject have an elevated serum calcium (total serum calcium value >10.2 mg/dl) after at least 14 days of a 1000 mg calcium and 800 IU vitamin D3 supplementation?
- Does the subject have a clinically significant elevation of serum alkaline phosphatase judged by the investigator?
- Does the subject have an impaired kidney function with creatinine clearance <30ml/min (indirect measurement by serum creatinine)?
- Does the subject have a severe hepatic impairment, defined as > 9 Child-Pugh score?
- Has the subject participated in a clinical trial with an Investigational Medicinal Product (IMP) during the last 30 days?
- Does the subject have a bilateral hip replacement?
- All exclusion criteria must be answered "no" for a subject to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label, Multi-centre, Longitudinal, Prospective, Phase IV Clinical Trial to Compare Two Image Technologies (ImaTx and DXA) Assessing the Anabolic Effects of PTH(1-84) in Postmenopausal Women With Primary Osteoporosis
The primary objective of the study is to explore the relationship between a new image technology (ImaTx), that analyzes the trabecular structure of the bone using digitized radiographs and the bone mineral density (BMD) measured by Dual X-ray Absorptiometry (DXA) in the lumbar spine of postmenopausal (PM) women with osteoporosis (OP) after treatment with PTH (1-84).
- Being tested
- Parathyroid hormone (PTH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parathyroid hormone (PTH)Drug
Also called Preotact
Postmenopausal women with primary osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficient between the percentage of increase in Bone Mineral Density (BMD) obtained by DXA in the lumbar spine and in Trabecular Fragment Length (TFL) obtained by ImaTx in digitised radiographs of lumbar spine from baseline to EOT
Measured: 72 weeks
Secondary outcomes (1)
BMD obtained by DXA in the lumbar spine (DXA SPI BMD). Two measurements will be determined: Mean value (g/cm2) and percentage of increase at EOT versus baseline (%).
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Women With Primary OsteoporosisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nycomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nycomed Clinical Trial Operations, Study chair, Headquaters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583518
- Sponsor's protocol ID
- FP-008-ES
- Status last verified
- May 2012
- First submitted
- 20 Dec 2007
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
- Open Label, Multi-centre, Longitudinal, Prospective, Phase IV Clinical Trial to Compare Two Image Technologies (ImaTx and DXA) Assessing the Anabolic Effects of PTH(1-84) in Postmenopausal Women With Primary Osteoporosis
- ClinicalTrials.gov ID
- NCT00583518
- Acronym / sponsor ID
- FP-008-ES
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- NycomedIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 Dec 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 primary objective of the study is to explore the relationship between a new image technology (ImaTx), that analyzes the trabecular structure of the bone using digitized radiographs and the bone mineral density (BMD) measured by Dual X-ray Absorptiometry (DXA) in the lumbar spine of postmenopausal (PM) women with osteoporosis (OP) after treatment with PTH (1-84).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has the subject given informed consent according to local requirements before any trial-related activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject.
- Is the subject a female?
- Is the subject 65 years old or above?
- Is the subject postmenopausal (more than 5 years), in the judgement of the investigator?
- Does the subject have primary osteoporosis, with a lumbar spine T score ≤ -3.0 SD, or a lumbar spine T-score ≤ -2.5 SD and previous fragility fracture[1], with a minimum of two evaluable lumbar vertebrae?
Key exclusion criteria (15 listed)
- Is the patient currently taking any of the following treatments: bisphosphonates, selective estrogen receptor modulators or hormone replacement therapy (if the patient discontinues any of these treatments at the screening visit, the question can be answered NO and the patient can be included)?
- Has the subject received, during her lifetime, strontium, fluoride or calcitonin > 3 months in total?
- Has the subject ever been treated with teriparatide or PTH(1-84)?
- Is the subject taking any other medication known to affect bone metabolism in the opinion of the investigator?
- Has the subject ever received radiation therapy to the skeleton?
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)Also: PreotactPostmenopausal women with primary osteoporosis | Drug | – |
Primary outcome
Correlation coefficient between the percentage of increase in Bone Mineral Density (BMD) obtained by DXA in the lumbar spine and in Trabecular Fragment Length (TFL) obtained by ImaTx in digitised radiographs of lumbar spine from baseline to EOT
Time frame: 72 weeks
1 secondary outcome
BMD obtained by DXA in the lumbar spine (DXA SPI BMD). Two measurements will be determined: Mean value (g/cm2) and percentage of increase at EOT versus baseline (%).
Time frame: 72 weeks
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.
Related trials for Postmenopausal Women With Primary Osteoporosis
Not yet recruitingObservational study
A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women
Menopause, Menopausal Hormone Therapy
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?
A Phase 4 study testing Parathyroid hormone (PTH) in people with Postmenopausal Women With Primary Osteoporosis, run by Nycomed 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 9 inclusion and 15 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Correlation coefficient between the percentage of increase in Bone Mineral Density (BMD) obtained by DXA in the lumbar spine and in Trabecular Fragment Length (TFL) obtained by ImaTx in digitised radiographs of lumbar spine from baseline to EOT (time frame: 72 weeks). 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 7 May 2012; AzTrials last refreshed its copy on 3 Nov 2026.