Kmetec, A., & Hajdinjak, T. (2013). Evaluation of safety and analgesic consumption in patients with advanced cancer treated with zoledronic acid. Radiology and Oncology, 47, 289–295.

DOI Link

Study Purpose

To evaluate zoledronic acid treatment in patients with advanced cancer and metastases to bone, in regards to safety and effectiveness (as measured by serum value of calcium, concurrent analgesic use, reported bone pain, and pathological bone fractures)

Intervention Characteristics/Basic Study Process

An observational clinical study was conducted that monitored patients with cancer receiving monthly zoledronic acid treatment for 12 months. At each visit, pain status was evaluated using a visual analog scale (VAS), as well as by monitoring prescribed analgesics. Lab values were obtained, and skeletal events (pathological bone fractures, spinal cord compression, or concurrent therapy to palliate bone lesions) were recorded. Monthly doses of zoledronic acid were prescribed and infused according to each disease’s treatment guidelines.

Sample Characteristics

  • N = 125  
  • AGE RANGE = 47–89 years
  • MEAN AGE = 69.2 years
  • MALES: 86%, FEMALES: 14%
  • KEY DISEASE CHARACTERISTICS: 73.6% had prostate cancer, and 22.4% were diagnosed with multiple myeloma.
  • OTHER KEY SAMPLE CHARACTERISTICS: Primarily prescribed for prevention of skeletal events

Setting

  • SITE: Mulit-site
  • SETTING TYPE: Outpatient 
  • LOCATION: Slovenia

Phase of Care and Clinical Applications

  • PHASE OF CARE: Palliative, end-of-life care
  • APPLICATIONS: Elder care, palliative care

Study Design

  • This was an observational, 12-month, multi-center study that monitored patients monthly for 12 months.

Measurement Instruments/Methods

At each monthly visit, measurements were taken as follows.

  • Analgesic consumption measured and recorded by type prescribed
  • Pain status measured on VAS
  • Lab values including serum creatinine, calcium, hemoglobin, albumin, alkaline phosphatase, bilirubin, aspartame aminotransferase, alanine aminotransferase, and prostate-specific antigen in patients with prostate cancer
  • Skeletal-related events

Results

The percentage of patients on analgesics decreased in the multiple myeloma group from 57%–24%. In the group with prostate cancer, this percentage increased from 70%–88%. Pain VAS scores decreased by 22% in the patients with prostate cancer and by 97% in those with multiple myeloma. Hypocalcemia was recorded in 4% of all participants. Thirty-one skeletal events were reported by 10 patients (rate of 8%).

Conclusions

Zoledronic acid as treatment for patients with multiple myeloma may account for diminished concurrent use of analgesics for the same group over the annual period observed. Patients receiving zoledronic acid treatment concurrently with analgesics experienced a reduction in all types of skeletal events. This does appear to be an effective treatment for patients diagnosed with prostate cancer, specifically in terms of prophylactic treatment with bone metastases, as it has shown a decrease in skeletal events and pathological fractures. It is not effective for palliation of pain symptoms for patients with pancreatic cancer, as analgesic use increased for this group of patients.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no appropriate attentional control condition)
  • Excluded patients receiving any cancer therapy other than painkillers

Nursing Implications

Nurses work with patients to identify and communicate concerns to treatment providers at the earliest possible onset. The results of this study indicate a need for nurses to continue to evaluate, educate, and assist patients to communicate concerns to providers for the purpose of pursuing earliest possible interventions that provide the maximum effectiveness and best possible outcome for quality of care provided and quality of life resulting from that care for each patient. These findings reiterate an area for nursing attention when evaluating patients with pain issues at all stages of disease from initial diagnosis to progression, end-stage, and palliative care.