OsteoporosisPhase 3NCT00058188
Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation
A Phase 3 study testing cholecalciferol, calcium gluconate and zoledronic acid in people with Osteoporosis and Prostate Cancer, run by Northwestern University at 3 sites in United States.
Trial summary
RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Osteoporosis, Prostate Cancer
- What is being tested?
- cholecalciferol, calcium gluconate and zoledronic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2003to Nov 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Stage III or IV disease
- Received at least 3 months of prior androgen deprivation therapy (no maximum amount/time) by either surgical or medical castration
- Medical castration may be by intermittent or continuous androgen suppression via single- or combined-drug androgen blockade
- Continued concurrent androgen deprivation therapy required throughout study participation
- No bone metastases by baseline bone scan
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 1 year
Hematopoietic
- Not specified
Hepatic
- Bilirubin less than 3 times upper limit of normal (ULN)
- AST and ALT less than 3 times ULN
- No chronic liver disease
Renal
- Creatinine no greater than 2.0 mg/dL
Other
- Fertile patients must use effective contraception
- No Paget's disease
- No Cushing's disease
- No hyperthyroidism
- No hyperprolactinemia
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Prior chemotherapy for prostate cancer allowed
Endocrine therapy
- See Disease Characteristics
- More than 12 months since prior suppressive doses of thyroxine or calcitonin
- More than 6 months since prior corticosteroids
- Concurrent corticosteroids allowed (after enrollment on study)
Radiotherapy
- Prior radiotherapy for prostate cancer allowed
Surgery
- See Disease Characteristics
Other
- More than 12 months since prior bisphosphonate therapy (oral or IV)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611-3013
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
John H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
About this study
Official title: A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation
RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss.
PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
Read the detailed description
OBJECTIVES:
- Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate.
- Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens.
- Compare markers of bone formation and resorption in patients treated with these regimens.
- Compare the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) in patients treated with these regimens.
- Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens.
- Compare the survival rate of patients treated with these regimens.
OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
- Arm II: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study.
- Conditions
- Osteoporosis, Prostate Cancer
- Being tested
- cholecalciferol, calcium gluconate, zoledronic acid
- Keywords
- osteoporosis, stage III prostate cancer, stage IV prostate cancer
- 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.
cholecalciferolDietary supplement
Given orally
calcium gluconateDrug
Given orally
zoledronic acidDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity. Receives: Dietary Supplement: cholecalciferol; Drug: calcium gluconate; Drug: zoledronic acid |
| Arm II | Active comparator | Patients receive oral calcium gluconate and oral cholecalciferol as in arm I. Receives: Dietary Supplement: cholecalciferol; Drug: calcium gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months
To assess bone density change as measured by dual-energy x-ray absorptiometry
Measured: Bone scan taken at baseline and month 13
Secondary outcomes (4)
Percentage Change in Lumbar Spine and Hip Bone Density as Measured by Plain Film X-rays of Lumbar Spine and Pelvis From Baseline to 13 Months
To assess the percentage change in lumbar spine and hip bone density as measured by plain film x-rays of lumbar spine and pelvis
Measured: Lumbar spine and hip bone density taken at baseline and month 13.
Markers of Bone Formation and Resorption
To assess markers of bone formation and resorption.
Measured: Bone alkaline phosphatase taken at baseline, month 6 and month 13.
Incidence of Skeletal Events (Pathologic and Non-pathologic Bone Fractures, Spinal Cord Compression, Surgery to Bone, and Radiotherapy to Bone)
To assess the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone)
Measured: PSA taken at baseline, month 3, month 6, month 9, month 12 and month 13. CT scan of abdomen and pelvis taken at baseline and month 13. Serum testosterone, estradiol, parathyroid taken at baseline, month 6 and month 13.
Incidence of New or Progressive Bone Metastatic Disease
To assess the incidence of new or progressive bone metastatic disease
Measured: Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startMar 2003
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Closed by the research committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Charles L. Bennett, MD, PhD, Study chair, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058188
- Sponsor's protocol ID
- NU 02U1
- Status last verified
- Oct 2020
- First submitted
- 7 Apr 2003
- Last updated
- 8 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation
- ClinicalTrials.gov ID
- NCT00058188
- Acronym / sponsor ID
- NU 02U1
- Conditions
- Osteoporosis, Prostate Cancer
- Keywords
- osteoporosis, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed by the research committee
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Mar 2003 (actual)
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 9 Apr 2003 (estimated)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss.
PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.
Detailed description
OBJECTIVES:
- Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate.
- Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens.
- Compare markers of bone formation and resorption in patients treated with these regimens.
- Compare the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) in patients treated with these regimens.
- Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens.
- Compare the survival rate of patients treated with these regimens.
OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity.
- Arm II: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: cholecalciferol, Drug: calcium gluconate, Drug: zoledronic acidPatients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity. |
| Arm II | Active comparator | Dietary Supplement: cholecalciferol, Drug: calcium gluconatePatients receive oral calcium gluconate and oral cholecalciferol as in arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cholecalciferolGiven orally | Dietary supplement | Arm I, Arm II |
| calcium gluconateGiven orally | Drug | Arm I, Arm II |
| zoledronic acidGiven IV | Drug | Arm I |
Primary outcome
Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months
Time frame: Bone scan taken at baseline and month 13
To assess bone density change as measured by dual-energy x-ray absorptiometry
4 secondary outcomes
Percentage Change in Lumbar Spine and Hip Bone Density as Measured by Plain Film X-rays of Lumbar Spine and Pelvis From Baseline to 13 Months
Time frame: Lumbar spine and hip bone density taken at baseline and month 13.
Markers of Bone Formation and Resorption
Time frame: Bone alkaline phosphatase taken at baseline, month 6 and month 13.
Incidence of Skeletal Events (Pathologic and Non-pathologic Bone Fractures, Spinal Cord Compression, Surgery to Bone, and Radiotherapy to Bone)
Time frame: PSA taken at baseline, month 3, month 6, month 9, month 12 and month 13. CT scan of abdomen and pelvis taken at baseline and month 13. Serum testosterone, estradiol, parathyroid taken at baseline, month 6 and month 13.
Incidence of New or Progressive Bone Metastatic Disease
Time frame: Serum osteocalcin and serum bone alkaline phosphatase taken at baseline, month 6 and month 13.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Charles L. Bennett, MD, PhD study chair
Robert H. Lurie Cancer Center
3 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 cholecalciferol, calcium gluconate and zoledronic acid in people with Osteoporosis and Prostate Cancer, run by Northwestern University at 3 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?
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: stopped early, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months (time frame: Bone scan taken at baseline and month 13). 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 8 Dec 2020.