Unlock the power to be your own CRO.

Clinical Research Coordinator Analysis

Adjunctive Medication Provision (Calcium/Vitamin D)

Finding: Section 5.4, regarding mandatory daily calcium (≥ 500 mg) and Vitamin D (≥ 400 IU) supplementation, states supplements "may be provided by the investigator or obtained by the subject." This flexibility creates potential for inconsistent participant adherence and difficulty in verifying compliance if subjects are expected to obtain supplements independently, potentially impacting safety and data integrity. Recommendation: For operational consistency and to maximize adherence, the site should develop a standardized plan for this study. The preferred approach is for the site to dispense protocol-specified calcium and Vitamin D supplements to all participants (e.g., as non-investigational product study supply). If site provision is not feasible, a robust documented process for participant education on required dosages, verification of purchase/access (e.g., providing specific brand/dosage recommendations, checking receipts or supplement bottles), and ongoing adherence monitoring (e.g., using patient-reported logs, pill counts at visits) must be implemented. Rationale: Standardizing the supplementation process enhances participant safety by minimizing hypocalcemia risk (a known adverse event associated with denosumab), ensures all participants meet protocol requirements for essential adjunctive care, and improves the reliability of compliance data, thereby reducing potential confounding factors for study outcomes and minimizing queries.