Hypocalcemia
Conditions
Interventions
Control group:None
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18–80, female. 2.Histologically or cytologically confirmed breast cancer with at least one bone metastatic lesion confirmed by imaging or pathology; 3.Plan to receive, or have initiated within =6 months, ECOG performance status 0–2. 6.Able to accept and comply with baseline risk assessment and tiered pharmaceutical care follow-up (Level I/II/III);
Exclusion criteria
Exclusion criteria: 1.Have received intravenous or oral bisphosphonates, recombinant PTH, or other interventions targeting RANKL/bone homeostasis within the previous 6 months. 2.History of severe allergy to Denosumab or any of its excipients. 3.Presence of active intracranial or spinal cord compressive lesions requiring urgent surgical or radiotherapy intervention. 4.Presence of other prior or concurrent malignancies (excluding carcinoma in situ of the cervix, basal cell carcinoma, or cured non-melanoma skin cancer) with active disease within the past 5 years. 5.Pregnancy or lactation, or positive urine/serum hCG at enrollment. 6.Currently participating in another interventional clinical study that may affect bone metabolism or the efficacy/safety of Denosumab. 7.Mental, cognitive, or social factors limiting the ability to comply with the study follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe hypocalcemia within 12 weeks (corrected blood calcium <1.8 mmol/L or <7.5 mg/dL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in the lowest blood calcium levels;Time for blood calcium to return to normal (the time from the first occurrence of hypocalcemia until blood calcium remains >2.12 mmol/L);Incidence of hypocalcemia-related symptoms (such as hand and foot spasms, arrhythmias, etc.);Adoption Rate of Clinical Pharmacist Interventions and Patient Compliance;Patient satisfaction with pharmaceutical services;Denosumab treatment discontinuation rate;Cost-effectiveness analysis (e.g., reduced hospital/ER visits vs. increased monitoring costs); | — |
Countries
China
Contacts
Public ContactLi Yan
Guangxi Medical University Cancer Hospital
Outcome results
None listed