Clinical trial · Observational
Study to Investigate Adherence of Patients to Clodronate (Bonefos) Treatment
BONA (Adherence of Patients to Bonefos Therapy). Prospective Observational Non-interventional Study of Adherence of Patients to Bonefos Medication in Relation to Analgesic Effect and Incidence of Skeletal Events
- 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)
Adherence (or compliance with) a medication regimen is generally defined as the extent to which patients take medication as prescribed by their health care providers. The adherence to medications has close relation to effectiveness of the therapy. The primary objective of this study is to observe the adherence to treatment with oral clodronate (PDC, proportion of days covered, number of days in which clodronate is taken according to treating physician recommendation) in patients with malignancy. The secondary "hypothesis generating" objective is to describe the relation between adherence to treatment with oral clodronate and efficacy of the therapy (skeletal events, pain).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Osteolysis | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clodronate (Bonefos, BAY94-8393) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: Clodronate (Bonefos, BAY94-8393)
Primary outcomes (1)
- measure
- Adherence to treatment with oral clodronate (PDC, proportion of days covered).
- timeFrame
- 12 months of therapy.
Secondary outcomes (2)
- measure
- Efficacy evaluation of the therapy based on incidence of skeletal events
- timeFrame
- 12 months
- measure
- Efficacy of the therapy in pain releif will be investigated exploratory based on questionnaire
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of breast cancer, prostate cancer, multiple myeloma and other skeletal events causing tumors * Bone metastases * Therapy with clodronate (1600 mg per day, 800 mg tablets) according to SmPC (Summary of Product Characteristics) Bonefos. * By agreeing to usage of patients diaries and goodwill with accounting of tablets Exclusion Criteria: * According to SmPC (Summary of Product Characteristics) Bonefos.
References
Publications (0)
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