Prostate CancerPhase 3NCT00426777
Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
A Phase 3 study testing risedronate in people with Prostate Cancer, run by CMX Research at 21 sites in Canada.
Trial summary
Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- risedronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 21 sitesCanada
- Study dates
- Jan 2007to Feb 2009
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age.
- Histologically confirmed diagnosis of prostate cancer without metastases.
- Patient must have negative bone scan to rule out bone metastases.
- Patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year.
- Eastern Cooperative Oncology Group (ECOG) score of 0 - 2.
- Study medication must be started within 3 months of initiation of ADT.
- Signed written informed consent.
Who cannot join
- Prior ADT (greater than 3 months).
- History of treatment with calcitriol or bisphosphonates.
- Suppressive doses of thyroxine within the previous year.
- Concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids.
- Evidence of any of the following conditions per subject self-report or chart review:
- Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if TSH is within normal reference range).
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- Paget's disease, Cushing's disease, hyperprolactinemia, chronic liver disease. Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization.
- Major surgery or significant traumatic injury occurring within 1 month prior to randomization.
- Known hypersensitivity to leuprolide acetate or any of the components found in Eligard
- Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Canada21 sites
The Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1
Dr. Stanley Flax
Brampton, Ontario, L6T 3J1
Brantford Urology Research, Medical Arts Building
Brantford, Ontario, N3R 4N3
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, L7N 3V2
Urology Research Centre
Burlington, Ontario, L7S 1V2
Dr. Allan Patrick
Fredericton, New Brunswick, E3B 5B8
Northern Urology Centre
Greater Sudbury, Ontario, P3E 4T3
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3
Guelph Urology Associates
Guelph, Ontario, N1H 5J1
Southern Interior Medical Research Corporation
Kelowna, British Columbia, V1Y 2H4
Credit Valley Medical Arts Centre
Mississauga, Ontario, L5M 4N4
Mor Urology Inc., Bayview Business Centre
Newmarket, Ontario, L3X 1W1
The Male and Female Health Centre
Oakville, Ontario, L6H 3P1
Orillia Urology Associates
Orillia, Ontario, L3V 7V1
Urotec
Oshawa, Ontario, L1H 1B9
Dr. Todd Webster
Owen Sound, Ontario, N4K 2J1
Kawartha Urology Associates
Peterborough, Ontario, K9H 1T6
Dr. Allan Abramovitch
Scarborough Village, Ontario, M1S 4V5
Dr. Cal Andreou
Surrey, British Columbia, V3V 1N1
The Male Health Centre
Toronto, Ontario, M6A 3B5
Dr. Roger J. Buckley
Willowdale, Ontario, M2K 2W1
About this study
Official title: A Randomized, Single-blind, Placebo-controlled, Multicentre Study to Evaluate the Effect of Risedronate and Placebo on Bone Mineral Density in Men Undergoing Androgen Deprivation Therapy With Leuprolide Acetate
Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.
Read the detailed description
IV bisphosphonates have proven effective in treating bone loss in prostate cancer patients treated with LHRH agonists. However, it is yet to be determined if an oral bisphosphonate such as risedronate could offer the same benefits.
- Conditions
- Prostate Cancer
- Being tested
- risedronate, Control
- Keywords
- prostate cancer, prostatic adenoma, prostatic neoplasm
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risedronateDrug
Also called Actonel
risedronate 35mg tablet, weekly for 12 months
risedronateDrug
Also called Actonel
35mg weekly
ControlDrug
risedronate-matched placebo weekly
| Study group | Role | What they receive |
|---|---|---|
| risedronate | Active comparator | Not described Receives: Drug: risedronate |
| placebo | Placebo comparator | Not described Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density of the lumbar spine
Measured: 12 months
Secondary outcomes (1)
overall safety
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 posted25 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionFeb 2009
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMX Research
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Richard W Casey, M.D., Principal investigator, CMX Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426777
- Sponsor's protocol ID
- SA-CMX-01
- Status last verified
- Feb 2012
- First submitted
- 24 Jan 2007
- Last updated
- 3 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Placebo-controlled, Multicentre Study to Evaluate the Effect of Risedronate and Placebo on Bone Mineral Density in Men Undergoing Androgen Deprivation Therapy With Leuprolide Acetate
- ClinicalTrials.gov ID
- NCT00426777
- Acronym / sponsor ID
- SA-CMX-01
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostatic adenoma, prostatic neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- CMX ResearchUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 25 Jan 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.
Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.
Detailed description
IV bisphosphonates have proven effective in treating bone loss in prostate cancer patients treated with LHRH agonists. However, it is yet to be determined if an oral bisphosphonate such as risedronate could offer the same benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| risedronate | Active comparator | Drug: risedronate |
| placebo | Placebo comparator | Drug: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 18 years of age.
- Histologically confirmed diagnosis of prostate cancer without metastases.
- Patient must have negative bone scan to rule out bone metastases.
- Patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year.
- Eastern Cooperative Oncology Group (ECOG) score of 0 - 2.
Key exclusion criteria (10 listed)
- Prior ADT (greater than 3 months).
- History of treatment with calcitriol or bisphosphonates.
- Suppressive doses of thyroxine within the previous year.
- Concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids.
- Evidence of any of the following conditions per subject self-report or chart review:
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 |
|---|---|---|
| risedronateAlso: Actonelrisedronate 35mg tablet, weekly for 12 months | Drug | risedronate |
| risedronateAlso: Actonel35mg weekly | Drug | risedronate |
| Controlrisedronate-matched placebo weekly | Drug | placebo |
Primary outcome
bone mineral density of the lumbar spine
Time frame: 12 months
1 secondary outcome
overall safety
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 3 Feb 2012.
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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.
Richard W Casey, M.D. principal investigator
CMX Research
21 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 risedronate in people with Prostate Cancer, run by CMX Research at 21 sites in Canada.
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 7 inclusion and 10 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 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Canada. 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. Some participants in this study may receive a placebo. 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?
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?
bone mineral density of the lumbar spine (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 3 Feb 2012.