This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
121
Zoledronic acid concentrate (4 mg/5 milliliters \[ml\]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks.
Percentage of Participants With ≥1 SRE at the End of 1 Year on Study
SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys.
Time frame: 1 year
Time to First SRE on Study
The time to first SRE is defined as the date of enrollment to the date of the first occurrence of any SRE on the study. SRE includes pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. Participants who drop-out was treated as censored observations. Time to first SRE on the study was assessed by the Kaplan-Meier method.
Time frame: Up to 2 years
Percentage of Participants Who Experienced Pathologic Bone Fracture
Pathologic bone fractures are defined as bone fractures that occur spontaneously or as a result of trivial trauma.
Time frame: Years 1 and 2
Percentage of Participants Who Experienced Spinal Cord Compression
Spinal cord compression is caused by the impingement of a tumor on the spinal cord and is associated with neurologic impairment and/or back pain.
Time frame: Years 1 and 2
Percentage of Participants Who Experienced Radiation to Bone
Radiation therapy to bone events includes irradiation of bone to palliate painful lesions, to treat or prevent pathologic fractures, or to treat or prevent spinal cord compression.
Time frame: Years 1 and 2
Percentage of Participants Who Experienced Surgery to Bone
Surgery to bone events includes surgical procedures that are performed to set or stabilize pathologic fractures or areas of spinal cord compression and surgical procedures that are performed to prevent an imminent pathologic fracture or spinal cord compression.
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Time frame: Years 1 and 2
Percentage of Participants Who Experienced HCM
HCM is defined as corrected serum calcium ≥ 12.0 milligrams per deciliter (mg/dL) (3.00 millimoles per liter \[mmol/L\]), or a lower level of hypercalcemia that was symptomatic and required active treatment other than rehydration.
Time frame: Years 1 and 2
Skeletal Related Event (SRE) Rate
The SRE rate for each participant was calculated as the number of SREs/total follow-up time. SRE included pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM.
Time frame: Years 1 and 2
Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx)
uNTx is a biomarker used to measure the rate of bone turnover found in urine.
Time frame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS)
Time to Death
Time to death was defined as the time from the date of enrollment to the date of death. Participants who dropped out or completed the study were considered censored observations. Time to death was assessed by Kaplan-Meier method.
Time frame: Up to 2 years