Bone LossPhase 2NCT00181584
Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
A Phase 2 study testing Zoledronic acid in people with Bone Loss and Prostate Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Bone Loss, Prostate Cancer
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2003to Feb 2006
- Phase
- Phase 2
- 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
- Adenocarcinoma of the prostate
- Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months
- Corrected serum calcium > 8.4mg/dl and < 10.6mg/dl
- Serum creatinine < 2.0mg/dl
Who cannot join
- History of bone metastases by bone scan
- Treatment with bisphosphonate within one year
- History of metabolic disease
- Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
The primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.
Read the detailed description
- Patients will be randomized into 2 groups. At the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo.
- Zometa is administered intravenously over a 15 minute prior once in this one year study.
- All patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.
- All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. At month 12, a bone mineral density test will be repeated.
- Conditions
- Bone Loss, Prostate Cancer
- Being tested
- Zoledronic acid, Placebo
- Keywords
- Androgen deprivation therapy, bone loss, prostate cancer, Zoledronic Acid, Zometa
- Medical subject headings
- Bone Diseases, Metabolic, 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
Given intravenously once.
PlaceboOther
Given intravenously once.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Drug: Zoledronic acid |
| Group 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.
Measured: 3 years
Secondary outcomes (2)
To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo
Measured: 3 years
to assess the safety and tolerability of zoledronic acid.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Matthew R. Smith, MD, PhD, Massachusetts General Hospital
- Investigators
- Matthew Smith, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181584
- Sponsor's protocol ID
- 03-194
- Status last verified
- Jul 2013
- First submitted
- 9 Sep 2005
- Last updated
- 11 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zoledronic Acid to Prevent Bone Loss During Androgen Deprivation Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00181584
- Acronym / sponsor ID
- 03-194
- Conditions
- Bone Loss, Prostate Cancer
- Keywords
- Androgen deprivation therapy, bone loss, prostate cancer, Zoledronic Acid, Zometa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- Sep 2003
- Primary completion
- Feb 2006 (actual)
- First posted
- 16 Sep 2005 (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 primary objective of this study is to determine whether zoledronic acid (Zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.
Detailed description
- Patients will be randomized into 2 groups. At the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. Patients with osteoporosis will be treated with Zometa. Patients without osteoporosis will be randomly assigned to receive either Zometa or a placebo.
- Zometa is administered intravenously over a 15 minute prior once in this one year study.
- All patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 I.U of vitamin D) during the study.
- All patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. At month 12, a bone mineral density test will be repeated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Zoledronic acid |
| Group 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adenocarcinoma of the prostate
- Current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months
- Corrected serum calcium > 8.4mg/dl and < 10.6mg/dl
- Serum creatinine < 2.0mg/dl
Key exclusion criteria (4 listed)
- History of bone metastases by bone scan
- Treatment with bisphosphonate within one year
- History of metabolic disease
- Chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year
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: ZometaGiven intravenously once. | Drug | Group 1 |
| PlaceboGiven intravenously once. | Other | Group 2 |
Primary outcome
To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo.
Time frame: 3 years
2 secondary outcomes
To compare changes in biochemical markers of bone turnover between men treated with zoledronic acid and men treated with placebo
Time frame: 3 years
to assess the safety and tolerability of zoledronic acid.
Time frame: 3 years
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 11 Jul 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.
Matthew Smith, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zoledronic acid in people with Bone Loss and Prostate Cancer, run by Massachusetts General Hospital at 2 sites in United States.
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 4 inclusion and 4 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 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To compare change in bone mineral density from baseline to one year between men treated with Zometa (zoledronic acid) and men treated with placebo. (time frame: 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 11 Jul 2013.