Prostate CancerPhase 3OsteoporosisNCT00957606
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer
A Phase 3 study testing blood sampling, DXA-scan, bone scintigraphy in people with Prostate Cancer and Androgen Deprivation Therapy, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine the rate of osteoporosis among patients with advanced prostate cancer. to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Androgen Deprivation Therapy, Osteoporosis
- What is being tested?
- blood sampling, DXA-scan, bone scintigraphy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- Aug 2009to Sep 2013
- Phase
- Phase 3
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Prostate cancer
- Initiation of androgen deprivation therapy
- Oral and written informed consent
Who cannot join
- They withdraw their consent
- Treatment for osteoporosis within the last year
- Other malignancy
- Other bone disease, bedbound, use of steroid
Trial locations and contacts
2 sites in 1 country.
Mads H Poulsen, MD contact
Steen Walter, MD, DMSci, Professor contact
Denmark2 sites, 2 recruiting
- Recruiting
Department of Urology, Odense University Hospital
Odense, 5000
Mads H Poulsen, MD, Mads.Poulsen@ouh.regionsyddanmark.dk
Steen Walter
- Recruiting
Department of Urology, Roskilde Hospital
Roskilde, 4000
Claus Dahl, MD
About this study
Official title: Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer: Symptoms, Risc Factors, and Prevention
The purpose of this study is
- to determine the rate of osteoporosis among patients with advanced prostate cancer.
- to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis.
Read the detailed description
Patients with advanced prostate cancer are included at the initiating of androgen deprivation therapy.
The patients are followed for 2 years after inclusion with blood sampling, DXA-scan, questionnaire, bone scintigraphy.
- Conditions
- Prostate Cancer, Androgen Deprivation Therapy, Osteoporosis
- Being tested
- blood sampling, DXA-scan, bone scintigraphy
- Keywords
- Prostate cancer, androgen deprivation therapy, osteoporosis
- Medical subject headings
- Prostatic Neoplasms, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling, DXA-scan, bone scintigraphyProcedure or surgery
Blood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporosis, either T-score < -2,5 or osteoporosis fracture
Measured: 2½ years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zealand University Hospital
- Investigators
- Mads H Poulsen, MD, Principal investigator, Department of Urology, Odense University Hospital, DenmarkSteen Walter, MD, DMSci, Professor, Study chair, Department of Urology, Odense University Hospital, DenmarkMorten MF Nielsen, MD, Study chair, Department of Endocrinology, Odense University Hospital, DenmarkKim Brixen, MD, PhD, Professor, Study chair, Department of Endocrinology, Odense University Hospital, DenmarkClaus Dahl, MD, Study chair, Department of Urology, Roskilde Hospital, DenmarkPeter Eskildsen, MD, DMSci, Study chair, Department of Endocrinology, Køge Hospital, DenmarkOke Gerke, PhD, Study chair, University of Southern DenmarkBo Abrahamsen, MD, PhD, Professor, Study chair, Faculty of Health Sciences, University of Southern Denmark, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957606
- Sponsor's protocol ID
- PCa & Osteoporosis 09
- Other IDs
- S-20080004
- Acronym
- Osteoporosis
- Status last verified
- Apr 2011
- First submitted
- 11 Aug 2009
- Last updated
- 13 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer: Symptoms, Risc Factors, and Prevention
- ClinicalTrials.gov ID
- NCT00957606
- Acronym / sponsor ID
- Osteoporosis / PCa & Osteoporosis 09
- Conditions
- Prostate Cancer, Androgen Deprivation Therapy, Osteoporosis
- Keywords
- Prostate cancer, androgen deprivation therapy, osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Zealand University Hospital
- Study start
- Aug 2009
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 12 Aug 2009 (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 this study is
- to determine the rate of osteoporosis among patients with advanced prostate cancer.
- to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis.
Detailed description
Patients with advanced prostate cancer are included at the initiating of androgen deprivation therapy.
The patients are followed for 2 years after inclusion with blood sampling, DXA-scan, questionnaire, bone scintigraphy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Prostate cancer
- Initiation of androgen deprivation therapy
- Oral and written informed consent
Key exclusion criteria (4 listed)
- They withdraw their consent
- Treatment for osteoporosis within the last year
- Other malignancy
- Other bone disease, bedbound, use of steroid
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 |
|---|---|---|
| blood sampling, DXA-scan, bone scintigraphyBlood sampling 5 times DXA-scan 5 times Bone scintigraphy 3 times | Procedure or surgery | – |
Primary outcome
Osteoporosis, either T-score < -2,5 or osteoporosis fracture
Time frame: 2½ years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2011.
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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.
Mads H Poulsen, MD contact
Steen Walter, MD, DMSci, Professor contact
Mads H Poulsen, MD principal investigator
Department of Urology, Odense University Hospital, Denmark
Steen Walter, MD, DMSci, Professor study chair
Department of Urology, Odense University Hospital, Denmark
Morten MF Nielsen, MD study chair
Department of Endocrinology, Odense University Hospital, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing blood sampling, DXA-scan, bone scintigraphy in people with Prostate Cancer and Androgen Deprivation Therapy, run by Odense University Hospital at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 13 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mads H Poulsen, MD (Mads.Poulsen@ouh.regionsyddanmark.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoporosis, either T-score < -2,5 or osteoporosis fracture (time frame: 2½ years). 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 13 Apr 2011.