Clinical trial · Observational
Bone Health Observational Study
A Prospective Study to Evaluate the Incidence of Skeletal Related Events In Prostate Cancer Patients Undergoing Androgen Deprivation Therapy (ADT).
- 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)
Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral Density (BMD). Using a prospective, observational study design, we propose that monitoring how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study will provide some of the first prospective data on the rates of Skeletal Related Events (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the use of DEXA screening for prostate cancer 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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- 1
- description
- Normal - BMD with T-score at or above -1.0
- label
- 2
- description
- Osteopenic - BMD with T-score between -1.1 and -2.4
- label
- 3
- description
- Osteoporotic - BMD with T-score at or below -2.5
Primary outcomes (1)
- measure
- Bone Mineral Density of the lumbar spine
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- Overall Safety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients willing to provide written Informed Consent. * Patients for whom Androgen Deprivation Therapy (ADT) with Zoladex® is indicated for at least 1 year. * Patients started on Zoladex® within the last 4 months. Exclusion Criteria: * Patient had surgery or significant traumatic injury occurring within 1 month prior to consent. * Known hypersensitivity to Goserelin Acetate or any of the components found in Zoladex®. * Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.
References
Publications (0)
Data not yet available