Prostatic NeoplasmsNCT00489905
Study on Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
A study testing Zolderonic acid (Zometa) in people with Prostatic Neoplasms and Bone Density, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Bone Density
- What is being tested?
- Zolderonic acid (Zometa)
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Apr 2005to May 2008
- Phase
- Interventional
- 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 50 to 80 years
- Men only
- Adult, Older adult
Who may be able to join
- Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline BMD in between -2 standard deviation (SD) and mean of that among young adults.
Who cannot join
- Patients with renal or liver problems, on calcium or other bisphosphonate therapy within six months before enrolling into the study.
- Patients who have:
- Serum creatinine levels >212 µmol/L (2.4 mg/dL).
- Creatinine clearance <50 ml/min.
- WBC <4.0x109/L, Hgb <10 g/dL, platelets <140x109/L. Patients with known hypersensitivity to bisphosphonates. Patients with history of diseases with influence on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or osteoporosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
The purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy.
- Conditions
- Prostatic Neoplasms, Bone Density
- Being tested
- Zolderonic acid (Zometa)
- Keywords
- prostate cancer, bone mineral density
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolderonic acid (Zometa)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density of lumber spine
Measured: 12 months after administration of zolderonic acid
Bone mineral density of femoral neck
Measured: 12 months after administration of zolderonic acid
Secondary outcomes (2)
Change in serum creatinine, calcium, phosphate and alkaline phosphatase
Measured: From time of enrollment to 3 months after the last intervention
Change in creatinine clearance
Measured: From time of enrollment to 3 months after the last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startApr 2005
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Baxter Healthcare Corporation
- Investigators
- Chi Fai Ng, Dr, Principal investigator, Department of Surgery, Division of Urology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489905
- Sponsor's protocol ID
- CRE-2005.137-T
- Other IDs
- HARECCTR0500010
- Status last verified
- Oct 2013
- First submitted
- 20 Jun 2007
- Last updated
- 23 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Zoledronic Acid to Prevent Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00489905
- Acronym / sponsor ID
- CRE-2005.137-T
- Conditions
- Prostatic Neoplasms, Bone Density
- Keywords
- prostate cancer, bone mineral density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Apr 2005
- Study completion
- May 2008 (actual)
- First posted
- 21 Jun 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 purpose of this study is to assess the effect of zoledronic acid on bone mineral density in prostatic cancer patients currently receiving androgen deprivation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prostate cancer patients aged between 50-80 who is having or will have ADT. Baseline BMD in between -2 standard deviation (SD) and mean of that among young adults.
Key exclusion criteria (5 listed)
- Patients with renal or liver problems, on calcium or other bisphosphonate therapy within six months before enrolling into the study.
- Serum creatinine levels >212 µmol/L (2.4 mg/dL).
- Creatinine clearance <50 ml/min.
- WBC <4.0x109/L, Hgb <10 g/dL, platelets <140x109/L. Patients with known hypersensitivity to bisphosphonates. Patients with history of diseases with influence on bone metabolism, such as Page's disease of bone, primary hyperparathyroidism or osteoporosis.
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 |
|---|---|---|
| Zolderonic acid (Zometa) | Drug | – |
Primary outcome
Bone mineral density of lumber spine
Time frame: 12 months after administration of zolderonic acid
Bone mineral density of femoral neck
Time frame: 12 months after administration of zolderonic acid
2 secondary outcomes
Change in serum creatinine, calcium, phosphate and alkaline phosphatase
Time frame: From time of enrollment to 3 months after the last intervention
Change in creatinine clearance
Time frame: From time of enrollment to 3 months after the last intervention
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 23 Oct 2013.
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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.
Chi Fai Ng, Dr principal investigator
Department of Surgery, Division of Urology, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zolderonic acid (Zometa) in people with Prostatic Neoplasms and Bone Density, run by Hospital Authority, Hong Kong at 1 site in China.
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 1 inclusion and 5 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 23 Oct 2013. 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 China. 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 lumber spine (time frame: 12 months after administration of zolderonic acid). The study lists 2 primary outcomes in all. 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 23 Oct 2013.