Back to resultsMaintaining Bone Strength in Men With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, Cancer treatment induced bone loss (CTIBL), Androgen deprivation therapy (ADT)
Eligibility Criteria
Inclusion criteria:
Histologically confirmed diagnosis of carcinoma of the prostate
- No distant metastases
- Patients must be candidates for androgen deprivation therapy (ADT)
- Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible
Exclusion criteria:
Patients with normal BMD at trial entry
- Patients who received any prior bisphosphonate therapy in the past 12 months
- Treatment with anti-androgen mono- or combination therapy
- Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES
- Patients who have received prior treatment with systemic corticosteroids within the past 12 months
- Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
- Patients with any prior treatment for osteoporosis
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
Outcomes
Primary Outcome Measures
Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan
Secondary Outcome Measures
To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on:
The percent change in BMD of the total hip following one year of therapy and the forearm following one year of therapy. This will be carried out at a limited number of centres.
Quality of life following one year of therapy.
Various biochemical markers of bone resorption (N-telopeptide, NTX, C-telopeptide, CTX, TRACP, PINP) and bone formation (bone alkaline phosphatase, BAP) during one year of therapy. This will be carried out at a limited number of centres.
Percentage of and rate of vertebral and hip fractures.
Safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00391950
Brief Title
Maintaining Bone Strength in Men With Prostate Cancer
Official Title
An Open-Label, Randomized, Multicentre Study to Evaluate the Efficacy of Two Zoledronic Acid Schedules on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year, in increasing bone strength in men with prostate cancer. All participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months. Both patient and doctor will know which treatment a patient is receiving.
After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study. All participants will stop receiving the drug after 1 year and will be seen back in the clinic, annually for another 2 years for follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Cancer treatment induced bone loss (CTIBL), Androgen deprivation therapy (ADT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Primary Outcome Measure Information:
Title
Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan
Secondary Outcome Measure Information:
Title
To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on:
Title
The percent change in BMD of the total hip following one year of therapy and the forearm following one year of therapy. This will be carried out at a limited number of centres.
Title
Quality of life following one year of therapy.
Title
Various biochemical markers of bone resorption (N-telopeptide, NTX, C-telopeptide, CTX, TRACP, PINP) and bone formation (bone alkaline phosphatase, BAP) during one year of therapy. This will be carried out at a limited number of centres.
Title
Percentage of and rate of vertebral and hip fractures.
Title
Safety and tolerability
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Histologically confirmed diagnosis of carcinoma of the prostate
No distant metastases
Patients must be candidates for androgen deprivation therapy (ADT)
Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible
Exclusion criteria:
Patients with normal BMD at trial entry
Patients who received any prior bisphosphonate therapy in the past 12 months
Treatment with anti-androgen mono- or combination therapy
Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES
Patients who have received prior treatment with systemic corticosteroids within the past 12 months
Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
Patients with any prior treatment for osteoporosis
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
City
Derby
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Maintaining Bone Strength in Men With Prostate Cancer
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