Evaluate Time Associated With the Preparation & Administration of Denosumab/Pamidronate in Patients With Solid Tumors and Metastatic Bone Disease

An Open-Label, Multicentre Trial to Evaluate the Time Associated With the Preparation and Administration of Denosumab and Pamidronate in Subjects With Solid Tumors and Metastatic Bone Disease in Canada

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02101164

Enrollment

Registered

2014-04-02

Start date

2014-11-30

Completion date

2014-11-30

Last updated

2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Bone Disease, Solid Tumor

Brief summary

This study will estimate the total time for the preparation and administration of denosumab and the total time for the preparation and administration of pamidronate.

Interventions

BIOLOGICALdenosumab

Treatment Group A - 120 mg SC dose every 4 weeks at Day 1 and week 5 Treatment Group B - 120 mg SC dose every 4 weeks at Week 9 and Week 13

DRUGpamidronate

Treatment Group A - 90 mg IV dose every 4 weeks at Week 9 and Week 13 Treatment Group B - 90 mg IV dose every 4 weeks at Day 1 and Week 5

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of metastatic bone disease secondary to a solid tumor (eg, breast cancer, lung cancer, etc). * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subject is one of the following: * being considered for pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease (prescribed per Canadian product monograph); OR * scheduled to receive pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease (prescribed per Canadian product monograph); OR * currently receiving pamidronate IV infusions or denosumab SC injections for treatment of metastatic bone disease AND has received no more than 4 prior administration of either product combined (prescribed per Canadian product monograph). * Subject has a serum calcium or albumin-adjusted serum calcium ≥ 2.0 mmol/L (8.0 mg/dL) and ≤ 2.9 mmol/L (11.5 mg/dL)

Exclusion criteria

* Diagnosis with metastatic bone disease secondary to multiple myeloma or prostate cancer. * Severe renal impairment (creatinine clearance \< 30 mL/min) * Subject is being considered for ambulatory pamidronate administration using an infuser device (ie, baby bottle). * A known active infection with Hepatitis B virus or Hepatitis C virus. * Subject has known positive results for human immunodeficiency virus (HIV).Subject has a history of other malignancy within the past 5 years, other than: * Malignancy treated with curative intent and with no known active disease present for ≥ 5 years before enrollment and felt to be at low risk for recurrence by the treating physician * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * Adequately treated cervical carcinoma in situ without evidence of disease * Adequately treated breast ductal carcinoma in situ without evidence of disease * Prostatic intraepithelial neoplasia without evidence of prostate cancer * Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ. * Subject has a history or current evidence of osteonecrosis/osteomyelitis of the jaw, active dental or jaw condition that requires oral surgery, non-healed dental/oral surgery, or planned invasive dental procedure over the course of the study.

Design outcomes

Primary

Measure	Time frame
Total duration (in hours, minutes and seconds) for investigational product preparation and administration	Day 1

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026