OsteoporosisNCT00520052
Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
A study testing zoledronic acid in people with Osteoporosis, run by Wirral University Teaching Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2003to Aug 2005
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on LHRH agonists (LHRH Group). Also patients who have been commenced on Bicalutamide due to osteoporosis at presentation (Bicalutamide Group)
Who cannot join
- patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wirral Hospitals Universirt NHS Trust
Upton, Wirral, Merseyside, CH48 5PE
About this study
The aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer
Read the detailed description
Androgen Deprivation Therapy is the mainstay of treatment for advanced prostate cancer. However they are associated with accelerated bone loss, osteoporosis and fractures. Previous studied looking at the use of zoledronic acid have predominantly studied men with a normal or osteopenic bone mineral density. However, it has been shown that upto 40% of men presenting with prostate cancer have osteoporosis and it is these who are at most risk of osteoporotic fractures. Our aim was to evaluate the efficiency of zoledronic acid in 2 groups of osteoporotic patients, those undergoing treatment with LHRH agonists and with antiandrogens.Peripheral and axial bone densitometry will be used to measure percentage changes in bone mineral density over 3 years. The first year with the patients on LHRH or antiandrogen, the second year continuing with their androgen deprivation therapy and zoledronic acid. Then bone mineral density will be measured one year following the last infusion of zoledronic acid to ascertain the optimum frequency of administration.
The study will also involve monitoring serum and urine bone turnover markers.
- Conditions
- Osteoporosis
- Being tested
- zoledronic acid
- Keywords
- bisphosphonates, prostate cancer, bone density, osteoporosis
- Medical subject headings
- Osteoporosis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
Also called zometa
5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline)
| Study group | Role | What they receive |
|---|---|---|
| LHRH Group | Active comparator | Patients on LHRH agonists and zoledronic acid Receives: Drug: zoledronic acid |
| Bicalutamide Group | Active comparator | Patients on Bicalutamide and zoledronic acid Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
axial and peripheral bone mineral density
Measured: over 3 years
Secondary outcomes (1)
serum and urine bone turnover markers
Measured: over 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2003
- Study completionAug 2005
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wirral University Teaching Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Nigel J Parr, MBBS, FRCS, MD, Principal investigator, Wirral Hospital University NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520052
- Sponsor's protocol ID
- 57/03
- Status last verified
- Aug 2007
- First submitted
- 22 Aug 2007
- Last updated
- 23 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Zoledronic Acid to Prevent Further Bone Loss in Osteoporotic Patients Requiring Androgen Deprivation Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00520052
- Acronym / sponsor ID
- 57/03
- Conditions
- Osteoporosis
- Keywords
- bisphosphonates, prostate cancer, bone density, osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wirral University Teaching Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Aug 2003
- Study completion
- Aug 2005 (actual)
- First posted
- 23 Aug 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 aim of this study is to determine if 3 monthly infusions of zoledronic acid, given over one year, improves the bone mineral density in osteoporotic patients undergoing androgen deprivation therapy for prostate cancer
Detailed description
Androgen Deprivation Therapy is the mainstay of treatment for advanced prostate cancer. However they are associated with accelerated bone loss, osteoporosis and fractures. Previous studied looking at the use of zoledronic acid have predominantly studied men with a normal or osteopenic bone mineral density. However, it has been shown that upto 40% of men presenting with prostate cancer have osteoporosis and it is these who are at most risk of osteoporotic fractures. Our aim was to evaluate the efficiency of zoledronic acid in 2 groups of osteoporotic patients, those undergoing treatment with LHRH agonists and with antiandrogens.Peripheral and axial bone densitometry will be used to measure percentage changes in bone mineral density over 3 years. The first year with the patients on LHRH or antiandrogen, the second year continuing with their androgen deprivation therapy and zoledronic acid. Then bone mineral density will be measured one year following the last infusion of zoledronic acid to ascertain the optimum frequency of administration.
The study will also involve monitoring serum and urine bone turnover markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LHRH Group | Active comparator | Drug: zoledronic acidPatients on LHRH agonists and zoledronic acid |
| Bicalutamide Group | Active comparator | Drug: zoledronic acidPatients on Bicalutamide and zoledronic acid |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with locally advanced prostate cancer who progress from normal/ osteopenic bone mineral density to osteoporosis while on LHRH agonists (LHRH Group). Also patients who have been commenced on Bicalutamide due to osteoporosis at presentation (Bicalutamide Group)
Key exclusion criteria (1 listed)
- patients with elevated prostate specific antigen, any illness or medication that would affect bone and mineral metabolism, previous bisphosphonate treatment, severe hepatic or renal insufficiency.
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 |
|---|---|---|
| zoledronic acidAlso: zometa5 doses of 4mg iv given 3 monthly over one year (as infusion over 15 mins in 100 mls normal saline) | Drug | Bicalutamide Group, LHRH Group |
Primary outcome
axial and peripheral bone mineral density
Time frame: over 3 years
1 secondary outcome
serum and urine bone turnover markers
Time frame: over 1 year
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 Aug 2007.
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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.
Nigel J Parr, MBBS, FRCS, MD principal investigator
Wirral Hospital University NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zoledronic acid in people with Osteoporosis, run by Wirral University Teaching Hospital NHS Trust at 1 site in United Kingdom.
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 1 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 Aug 2007. 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 United Kingdom. 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?
axial and peripheral bone mineral density (time frame: over 3 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 23 Aug 2007.