Prostate CancerBHOSNCT00632905
Bone Health Observational Study
An observational study of Prostate Cancer, run by CMX Research at 40 sites in Canada.
Trial summary
Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral Density (BMD). Using a prospective, observational study design, we propose that monitoring how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 599 participants
- Where
- 40 sitesCanada
- Study dates
- Sep 2007to Mar 2016
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinics
Who may be able to join
- Patients willing to provide written Informed Consent.
- Patients for whom Androgen Deprivation Therapy (ADT) with Zoladex® is indicated for at least 1 year.
- Patients started on Zoladex® within the last 4 months.
Who cannot join
- Patient had surgery or significant traumatic injury occurring within 1 month prior to consent.
- Known hypersensitivity to Goserelin Acetate or any of the components found in Zoladex®.
- 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
40 sites in 1 country.
40 sites in 1 country
Canada40 sites
Dr. Jonathan L. Giddens
Brampton, Ontario, L6V 1B4
Brantford Urology Research Medical Arts Bldg.
Brantford, Ontario, N3R 4N3
G. Kenneth Jansz Medicine Professional Corporation
Burlington, Ontario, L7N 3V2
Dr. Richard Sowery
Burlington, Ontario, L7T 3K4
Dr. John A. Warner
Burnaby, British Columbia, V5G 1T4
Dr. Louis-Rene Barrette
Chicoutimi, Quebec, G7H 6B9
Recherches Cliniques Theradev
Granby, Quebec, J2G 8Z9
Northern Urology Centre
Greater Sudbury, Ontario, P3E 4T3
Guelph Urology Associates
Guelph, Ontario, N1H 5J1
Southern Interior Medical Research Corporation
Kelowna, British Columbia, V1Y 2H4
Bruce W. Palmer Urology Inc.
Kentville, Nova Scotia, B4N 4K9
Dr. Alvaro Morales
Kingston, Ontario, K7L 3J7
Polyclinique Med Concorde
Laval, Quebec, H7G 2E6
GU Trials Markham
Markham, Ontario, L6B 1A1
Nanaimo Urology Associates
Nanaimo, British Columbia, V9S 2B5
Mor Urology Inc
Newmarket, Ontario, L3X 1W1
Medical & Dental Bldg
North Bay, Ontario, P1B 4Y3
Stanley Flax Medicine Professional Corporation
North York, Ontario, M3B 3S6
York-Finch Med Centre
North York, Ontario, M3N 2V6
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1
Orillia Urology Associates
Orillia, Ontario, L3V 7V1
Urotec
Oshawa, Ontario, L1H 1B9
Mahoney Medicine Professional Corporation
Ottawa, Ontario, K1H 8L6
2150935 Ontario Inc
Owen Sound, Ontario, N4K 2J1
Kawartha Urology Associates
Peterborough, Ontario, K9H 1T6
The Medical Centre
Peterborough, Ontario, K9J 2X5
Ultra-Med Inc.
Point Claire, Quebec, H9R 4S3
Central Island Research Centre
Port Alberni, British Columbia, V9Y 8C8
Clinique d'Urologie du Saguenay
Saguenay, Quebec, G7H 4A3
Centre de Récherche en Urologie de Lanaudiére
Saint Charles-Baromee, Quebec, J6E 6J2
Medical Arts Bldg
Saskatoon, Saskatchewan, S7K 3H3
Dr. Allan Abramovitch
Scarborough Village, Ontario, M1S 4V5
Dr. Peter Roney
Smiths Falls, Ontario, K7A 2H9
Andreou Research
Surrey, British Columbia, V3V 1N1
West Arthur Place
Thunder Bay, Ontario, P7E 6E7
Dr. Edward Woods
Toronto, Ontario, M1P 2T7
The Male Health Centre
Toronto, Ontario, M6A 3B5
Westmount Med Bldg
Westmount, Quebec, H4A 1S9
Dr. Roger Buckley
Willowdale, Ontario, M2K 2W1
ABHM Associates
Windsor, Ontario, N8Y 4X9
About this study
Official title: A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).
Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral Density (BMD). Using a prospective, observational study design, we propose that monitoring how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study will provide some of the first prospective data on the rates of Skeletal Related Events (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the use of DEXA screening for prostate cancer patients.
Read the detailed description
A consequence of ADT is the gradual bone loss, so-called cancer treatment induced bone loss (CTIBL). The current standard of care is the addition of Vitamin D and Calcium upon the initiation of ADT. Moreover, bisphosphonates are now being considered to treat and prevent CTIBL. However, bisphosphonates are costly, thus there is a desire to identify or target a specific subset of patients who would most benefit from the treatment.
By obtaining baseline BMD and monitoring for Skeletal Related Events (SREs), we hope to identify that specific sub-set of patients who would most benefit from the treatment. Using a prospective, observational study design, we propose monitoring how physicians manage CTIBL in their patients.
- Conditions
- Prostate Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Normal - BMD with T-score at or above -1.0 | |
| 2 | Osteopenic - BMD with T-score between -1.1 and -2.4 | |
| 3 | Osteoporotic - BMD with T-score at or below -2.5 |
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 posted11 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2016
- Study completionMar 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMX Research
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Richard W Casey, M.D., Principal investigator, CMX Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632905
- Sponsor's protocol ID
- AZ-CMX-03
- Acronym
- BHOS
- Status last verified
- Sep 2017
- First submitted
- 20 Feb 2008
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).
- ClinicalTrials.gov ID
- NCT00632905
- Acronym / sponsor ID
- BHOS / AZ-CMX-03
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostatic adenoma, Prostatic neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- CMX ResearchUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2007
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Mar 2008 (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., goserelin) lose Bone Mineral Density (BMD). Using a prospective, observational study design, we propose that monitoring how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study will provide some of the first prospective data on the rates of Skeletal Related Events (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the use of DEXA screening for prostate cancer patients.
Detailed description
A consequence of ADT is the gradual bone loss, so-called cancer treatment induced bone loss (CTIBL). The current standard of care is the addition of Vitamin D and Calcium upon the initiation of ADT. Moreover, bisphosphonates are now being considered to treat and prevent CTIBL. However, bisphosphonates are costly, thus there is a desire to identify or target a specific subset of patients who would most benefit from the treatment.
By obtaining baseline BMD and monitoring for Skeletal Related Events (SREs), we hope to identify that specific sub-set of patients who would most benefit from the treatment. Using a prospective, observational study design, we propose monitoring how physicians manage CTIBL in their patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Normal - BMD with T-score at or above -1.0 |
| 2 | – | –Osteopenic - BMD with T-score between -1.1 and -2.4 |
| 3 | – | –Osteoporotic - BMD with T-score at or below -2.5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinics
Key inclusion criteria (3 listed)
- Patients willing to provide written Informed Consent.
- Patients for whom Androgen Deprivation Therapy (ADT) with Zoladex® is indicated for at least 1 year.
- Patients started on Zoladex® within the last 4 months.
Key exclusion criteria (3 listed)
- Patient had surgery or significant traumatic injury occurring within 1 month prior to consent.
- Known hypersensitivity to Goserelin Acetate or any of the components found in Zoladex®.
- 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.
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
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 28 Sep 2017.
- Individual participant dataSharing planned: Undecided
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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
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by CMX Research at 40 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 3 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 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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. 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?
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 28 Sep 2017.