OsteoporosisInoProNCT00816452
Awareness to Osteopenia's Treatment by Bisphosphonate in Male Suffering From Prostate Cancer
An observational study of Osteoporosis and Prostate Cancer, run by Sanofi at 1 site in Israel.
Trial summary
Patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician. Primary Objective: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Osteoporosis, Prostate Cancer
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Jul 2010
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male with Prostate Cancer suffering from Osteoporosis
Who may be able to join
- Man with Prostate Cancer
- Men ≥70 years old or ≥60 years old treated by LH-RH agonist for at least 2 years or Man who was diagnosed in the past with Osteopenia/osteoporosis
- Osteopenia/osteoporosis proven by bone density test.
Who cannot join
- Creatinine clearance < 30ml/min
- Hypercalcemia
- Actual treatment by Bisphosphonate or steroids
- Hypersensibility to Bisphosphonate or any contraindication to its use.
- Metastatic prostate Cancer
- Patients not suitable for compliance.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy - Registry.
Patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician.
Primary Objective: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.
Secondary objectives:
To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.
To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.
- Conditions
- Osteoporosis, Prostate Cancer
- Keywords
- Osteoporosis, Prostate Cancer, Osteoporosis in male with Prostate Cancer
- Medical subject headings
- Osteoporosis, Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.
Measured: 6 months
Secondary outcomes (3)
To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.
Measured: 6 months
To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics
Measured: 6 months
To evaluate incidence of osteopenia/osteoporosis in this study population.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionJul 2010
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 SanofiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nurit Tweezer, Study director, Sanofi-aventis administrative office Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816452
- Sponsor's protocol ID
- RISED_L_04261
- Acronym
- InoPro
- Status last verified
- Nov 2010
- First submitted
- 31 Dec 2008
- Last updated
- 3 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: Increase Awareness to Osteopenia/Osteoporosis Treatment of Patients With Prostate Cancer, by Bisphosphonate Therapy - Registry.
- ClinicalTrials.gov ID
- NCT00816452
- Acronym / sponsor ID
- InoPro / RISED_L_04261
- Conditions
- Osteoporosis, Prostate Cancer
- Keywords
- Osteoporosis, Prostate Cancer, Osteoporosis in male with Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Jan 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.
Patients with prostate cancer treated in outpatient clinics will be recruited by their urologist physician.
Primary Objective: To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.
Secondary objectives:
To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.
To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics, To evaluate incidence of osteopenia/osteoporosis in this study population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male with Prostate Cancer suffering from Osteoporosis
Key inclusion criteria (3 listed)
- Man with Prostate Cancer
- Men ≥70 years old or ≥60 years old treated by LH-RH agonist for at least 2 years or Man who was diagnosed in the past with Osteopenia/osteoporosis
- Osteopenia/osteoporosis proven by bone density test.
Key exclusion criteria (7 listed)
- Creatinine clearance < 30ml/min
- Hypercalcemia
- Actual treatment by Bisphosphonate or steroids
- Hypersensibility to Bisphosphonate or any contraindication to its use.
- Metastatic prostate Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis.
Time frame: 6 months
3 secondary outcomes
To evaluate the compliance of family physicians to prescribe Bisphosphonate for patients upon recommendation by Urologists.
Time frame: 6 months
To evaluate the overall number of patients treated by Bisphosphonate in the out-patient clinics
Time frame: 6 months
To evaluate incidence of osteopenia/osteoporosis in this study population.
Time frame: 6 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 3 Nov 2010.
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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.
Nurit Tweezer study director
Sanofi-aventis administrative office Israel
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 Osteoporosis and Prostate Cancer, run by Sanofi at 1 site in Israel.
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 7 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 3 Nov 2010. 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 Israel. 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?
To evaluate the compliance in male patients with prostate cancer treated with Bisphosphonate and that suffered from Osteopenia/osteoporosis. (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 3 Nov 2010; AzTrials last refreshed its copy on 8 Nov 2026.