NCT00126386

Zoledronic Acid (Zometa) for the Management of Tumor-induced Hypercalcemia (TIH) and Malignant Bone Pain (MBP) in the Community: A Feasibility Study

Extracted Fields (from Registry)
Protocol IDNCT00126386
Registration Date2005-08-04
Statuscompleted
SponsorAlberta Health services
CountryCanada
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2004-01-01
Last Patient Out2006-09-01
Publicationn
Gender %ALL
Mean Age18 Years -
LLM Classifications (Side-by-Side)
Field GLM
glm-5.1
12799ms / 8482 tok 		CLAUDE
claude-sonnet-4-20250514
Thinking: claude-opus-4-20250514
4729ms / 9698 tok 		OPENAI
gpt-4o
Thinking: o3
2966ms / 8338 tok 		Review
rct_type N/A N/A N/A OK
cancer_status Cancer Cancer Cancer OK
non_cancer_spec N/A N/A N/A OK
setting_patient mixed outpatient
shaky reasoning
✓ Unanimous Initial: outpatient
 mixed mixed → mixed → mixed
shaky reasoning
✓ Unanimous Initial: mixed Requery: mixed — The study explicitly includes treatment in multiple settings including homes (outpatient), hospices and long-term care facilities (inpatient), as stated in the title and description. Thinking: mixed — The study explicitly delivers treatment in both homes (outpatient) and hospices/long-term care facilities (inpatient).
 mixed outpatient → outpatient → mixed
shaky reasoning
✓ Unanimous Initial: outpatient Requery: outpatient — The intervention is delivered in the community, including at home and in hospices, which is considered outpatient care. Thinking: mixed — The study administers zoledronic acid either at patients’ homes (outpatient) or in hospice/long-term care facilities (inpatient), explicitly involving both settings.
 OK
setting_place home care home care
shaky reasoning
✗ No consensus Initial: home care
 home care home care → other → other
shaky reasoning
✗ No consensus Initial: home care Requery: other — The intervention is delivered in multiple community settings including homes, hospices, and long-term care facilities through a home parenteral therapy program, making it a mixed-location study that doesn't fit into a single specific category. Thinking: other — The intervention delivers treatment across multiple community settings including homes, hospices, and long-term care facilities, making it a mixed-location study.
 hospice hospice → home care → home care
shaky reasoning
✗ No consensus Initial: hospice Requery: home care — The intervention is delivered primarily in patients' homes, as indicated by the use of the home parenteral therapy program and a focus on community-based treatment. Thinking: home care — Zoledronic acid infusions are delivered via the home parenteral therapy program in community settings (patients’ own homes), with hospices/nursing homes mentioned only as secondary options.
feasibility feasibility RCT N/A → feasibility RCT
shaky reasoning
✓ Unanimous Initial: N/A Requery: feasibility RCT — The trial is explicitly identified as a 'Feasibility Study' in the title, the primary outcomes focus on evaluating the feasibility and required resources, and the enrollment count is very small (n=11).
 feasibility RCT feasibility RCT → feasibility RCT
shaky reasoning
✓ Unanimous Initial: feasibility RCT Requery: feasibility RCT — The title explicitly states 'A Feasibility Study' and the primary outcome is 'feasibility of treating hypercalcemia in the community', clearly indicating this is a pilot/feasibility study.
 feasibility RCT feasibility RCT → feasibility RCT
shaky reasoning
✓ Unanimous Initial: feasibility RCT Requery: feasibility RCT — The trial is explicitly described as a feasibility study focusing on evaluating resources required for community-based treatment.
 OK
intervention_pharmacologic yes yes yes OK
intervention_chemo_immuno_radio no no no OK
intervention_complementary no no no OK
intervention_device no no no OK
intervention_psychological no no no OK
intervention_complex no no no OK
intervention_acp no no no OK
intervention_music no no no OK
intervention_screening no no no OK
intervention_palliative no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The intervention is the drug zoledronic acid (a pharmacologic bisphosphonate) being tested in a palliative/home care setting, rather than palliative care itself being the intervention.
 no yes → no
shaky reasoning
✓ Unanimous Initial: yes Requery: no — This study tests zoledronic acid (a bisphosphonate drug) for treating hypercalcemia and bone pain in cancer patients, with the intervention being pharmacologic rather than palliative care consultation or service delivery.
 no no → no
shaky reasoning
✓ Unanimous Initial: no Requery: no — The trial tests zoledronic acid for hypercalcemia and pain management, not palliative care delivery itself.
 OK
intervention_education no no no OK
intervention_digital no no no OK
intervention_other no no no OK
outcome_symptom no no → no
shaky reasoning
✗ No consensus Initial: no Requery: no — The primary outcomes focus on feasibility and resource utilization, with no formal symptom measures listed among the study outcomes.
 yes yes → no → yes
shaky reasoning
✗ No consensus Initial: yes Requery: no — The primary outcomes focus on feasibility and resource requirements for community treatment, with no mention of measuring pain or other symptoms as outcomes despite pain being mentioned in eligibility criteria. Thinking: yes — The study uses NRS (numerical rating scale) to assess pain (≥6/10) as an inclusion criterion and focuses on treating malignant bone pain.
 no no → yes → no
shaky reasoning
✗ No consensus Initial: no Requery: yes — The trial involves assessing 'Moderate to severe intolerable pain' using a numerical rating scale (NRS), which is a specific symptom measure for pain. Thinking: no — Listed outcomes assess feasibility and resource use, with no stated measurement of symptoms such as pain, nausea, or other validated symptom scales.
outcome_qol no no no OK
outcome_dignity no no no OK
outcome_cost yes yes yes OK
outcome_other yes yes yes OK
pharmacologic_sub other other other OK
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