NCT00622505 · REGISTRY CONDITION SEARCH

Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: COMPLETED
Registry last update: 2021-05-26

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With ≥1 SRE at the End of 1 Year on Study

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outcome · POSTED

Time to First SRE on Study

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outcome · POSTED

Percentage of Participants Who Experienced Pathologic Bone Fracture

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outcome · POSTED

Percentage of Participants Who Experienced Spinal Cord Compression

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outcome · POSTED

Percentage of Participants Who Experienced Radiation to Bone

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outcome · POSTED

Percentage of Participants Who Experienced Surgery to Bone

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outcome · POSTED

Percentage of Participants Who Experienced HCM

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outcome · POSTED

Skeletal Related Event (SRE) Rate

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outcome · POSTED

Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx)

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outcome · POSTED

Time to Death

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Confirmed diagnosis of multiple myeloma * Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma * Stable renal function Exclusion Criteria: * Known sensitivity to bisphosphonates * Receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover * Current active dental problems * Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment Other protocol-defined inclusion/exclusion criteria may apply.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants received 4 milligrams (mg) or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes, every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine N-telopeptide of type 1 collagen (NTx) measurement (greater than or equal to \[≥\] 50 nanomoles per millimoles \[nmol/mmol\] creatinine or \<50 nmol/mmol creatinine, respectively).
intervention Names
Drug: zoledronic acid
label
Zoledronic acid
type
EXPERIMENTAL

interventions

arm Group Labels
Zoledronic acid
description
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.
name
zoledronic acid
other Names
Zometa
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

PREVENTION

Enrollment

count: 121
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Percentage of Participants With ≥1 SRE at the End of 1 Year on Study
time Frame
1 year

secondary Outcomes

description
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.
measure
Time to First SRE on Study
time Frame
Up to 2 years
description
Pathologic bone fractures are defined as bone fractures that occur spontaneously or as a result of trivial trauma.
measure
Percentage of Participants Who Experienced Pathologic Bone Fracture
time Frame
Years 1 and 2
description
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.
measure
Percentage of Participants Who Experienced Spinal Cord Compression
time Frame
Years 1 and 2
description
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.
measure
Percentage of Participants Who Experienced Radiation to Bone
time Frame
Years 1 and 2
description
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.
measure
Percentage of Participants Who Experienced Surgery to Bone
time Frame
Years 1 and 2
description
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.
measure
Percentage of Participants Who Experienced HCM
time Frame
Years 1 and 2
description
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.
measure
Skeletal Related Event (SRE) Rate
time Frame
Years 1 and 2
description
uNTx is a biomarker used to measure the rate of bone turnover found in urine.
measure
Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx)
time Frame
Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS)
description
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.
measure
Time to Death
time Frame
Up to 2 years

Full study description

brief Summary: 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.

Source references

references

citation
Raje N, Vescio R, Montgomery CW, Badros A, Munshi N, Orlowski R, Hadala JT, Warsi G, Argonza-Aviles E, Ericson SG, Anderson KC. Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: Results of the Z-MARK Study. Clin Cancer Res. 2016 Mar 15;22(6):1378-84. doi: 10.1158/1078-0432.CCR-15-1864. Epub 2015 Dec 7.
pmid
26644410
type
RESULT

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice