Clinical trial · Interventional
Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer
Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values
NCT00536653CI-TRIAL-00000895completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.
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 |
|---|---|---|---|
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bicalutamide and Calcium/ Vitamin D supplementation | Drug | — | UNRESOLVED |
| LHRH agonists (Goserelin acetate) | Drug | — | UNRESOLVED |
| LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Osteporosis Group
- description
- Patients with a presenting T score \< -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD
- interventionNames
- Drug: Bicalutamide and Calcium/ Vitamin D supplementation
- type
- ACTIVE_COMPARATOR
- label
- Osteopenia Group
- description
- Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD
- interventionNames
- Drug: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation
- type
- ACTIVE_COMPARATOR
- label
- Normal Group
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated Exclusion Criteria: * Previous systemic therapy for prostate cancer * Patients with any illness or medication that would affect bone and mineral metabolism * Severe hepatic or renal insufficiency
References
Publications (0)
Data not yet available
No reference posted for this study.