Clinical trial · Interventional
Maintaining Bone Strength in Men With Prostate Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in bone mineral density (BMD) at lumbar spine as assessed by dual energy x-ray absoptiometry (DEXA) scan
Secondary outcomes (6)
- measure
- To compare the effect of zoledronic acid 4 mg every 12 weeks versus every 24 weeks on:
- measure
- 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.
- measure
- Quality of life following one year of therapy.
- measure
- 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.
- measure
- Percentage of and rate of vertebral and hip fractures.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available