AzTrials
AzTrials

Breast CancerPhase 3NCT00365105

Zoledronate, Vitamin D, and Calcium With or Without Strontium 89 or Samarium 153 in Preventing or Delaying Bone Problems in Patients With Bone Metastases From Prostate Cancer, Lung Cancer, or Breast Cancer

A Phase 3 study testing Calcium, Vitamin D and zoledronic acid in people with Breast Cancer and Lung Cancer, run by Radiation Therapy Oncology Group at 147 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Lung Cancer, Metastatic Cancer
What is being tested?
Calcium, Vitamin D and zoledronic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
261 participants
Where
147 sitesUnited States
Study dates
11 Jul 2006to 27 Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically proven diagnosis of solid tumor malignancy of lung, breast, or prostate prior to registration;
  • Appropriate diagnosis for protocol entry, based upon the following minimum diagnostic workup:
  • 2.1 History/physical examination within 8 weeks prior to registration; 2.2 Bone scan within 4 weeks prior to registration; bone metastases must be visible on the scan. Other scanning modalities, such as magnetic resonance imaging (MRI), positron emission tomography (PET) 2.3 Dental evaluation according to the dental exam checklist (carried out by the investigator, the investigator's designee, or by a qualified dental professional [dental hygienist or dentist]), including history of dental surgery (e.g., extraction or implant) within 8 weeks prior to registration and recorded on the dental exam checklist; Note: If the patient has received prior oral bisphosphonate therapy and has had a prior dental evaluation within 8 weeks of registration, the evaluation should not be repeated.
  • 2.4 Complete blood count (CBC)/differential within 2 weeks prior to registration, with adequate bone marrow function defined as follows:
  • White blood cell count (WBC) ≥ 2400 cells/mm^3;
  • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
Show all 15Show fewer
  • Platelets ≥ 60,000 cells/mm3;
  • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve the required hemoglobin is permitted).
  • 2.5 Serum creatinine < 3 mg/dL (265 μmol/L) within 2 weeks prior to registration; 2.6 Total bilirubin < 2.5 mg/dL (43 μmol/L) within 2 weeks prior to registration; 2.7 Pregnancy test (urine dipstick or serum) for women of childbearing potential within 2 weeks prior to registration;
  • ≥ 18 years of age;
  • Zubrod performance status 0-2 for patients with breast or prostate primaries; Zubrod performance status 0-1 for patients with lung primaries;
  • Patients receiving systemic chemotherapy or hormonal therapy are eligible for this study. See Sections 6.0 and 7.0 for further details. Note: All patients must complete external beam radiation therapy ≥ 14 days prior to registration. If patients have undergone CyberKnife treatment, treatment must be completed ≥ 14 days prior to registration.
  • Patients may have received prior oral bisphosphonate therapy, such as Fosamax® or similar medications. Duration of bisphosphonate treatment prior to study entry must be documented, and all bisphosphonates other than the study drug must be discontinued prior to registration.
  • Women of childbearing potential and male participants must agree to practice an adequate means of birth control throughout their participation in the study.
  • Patient must sign study specific informed consent prior to study entry.

Who cannot join

  • Patients with brain metastases and/or spinal cord compression are excluded. Note: Patients with no evidence of disease in the brain after treatment for brain metastases are eligible.
  • Patients with painful bone metastases are not permitted until these bone metastases are successfully treated (for example by external beam irradiation) prior to registration, and the patient has stable pain for at least 2 weeks after that treatment (Stable pain is defined for this study as a patient response of 1, 2, or 3 on Questions 4 and 5 of The Brief Pain Inventory (BPI).
  • Prior treatment with Strontium-89 or Samarium-153 for bone metastases.
  • Treatment for more than 6 months with IV bisphosphonates prior to study entry;
  • Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to registration
  • Severe, active co-morbidity, defined as follows:
Show all 9Show fewer
  • 6.1 Evidence in the six months prior to study entry of uncontrolled congestive heart failure, hypertension refractory to treatment, or symptomatic coronary artery disease; 6.2 Current, active dental problems within 4 weeks of registration, including infection of the teeth or jawbone (maxilla or mandible); dental or fixture trauma; current or prior diagnosis of osteonecrosis of the jaw (ONJ); exposed bone in the mouth; or slow healing after dental procedures; 6.3 Dental surgery (e.g., extractions, implants) within 6 weeks of study entry and while receiving study treatment; for patients who require dental surgery, there are no data to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw (ONJ) [see Section 7.2.4].
  • 6.4 Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
  • Pregnant or lactating patients are excluded, as treatment may be harmful to embryos and/or nursing infants.

Trial locations and contacts

147 sites in 1 country.

147 sites in 1 country

United States147 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • New Mexico Cancer Center

    Albuquerque, New Mexico, 87109

  • Tulane Cancer Center Office of Clinical Research

    Alexandria, Louisiana, 71315-3198

  • Radiation Oncology Center

    Alliance, Ohio, 44601

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • Theda Care Cancer Institute

    Appleton, Wisconsin, 54911

  • Northwest Community Hospital

    Arlington Heights, Illinois, 60005

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • UPMC Cancer Center at Beaver Medical Center

    Beaver, Pennsylvania, 15009

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

    Burbank, California, 91505

  • Sands Cancer Center

    Canandaigua, New York, 14424

  • Mercy Cancer Center at Mercy Medical Center

    Canton, Ohio, 44708

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • UPMC Cancer Center at Jefferson Regional Medical Center

    Clairton, Pennsylvania, 15025

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Good Samaritan Cancer Care Center at Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515-1500

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Hudner Oncology Center at Saint Anne's Hospital - Fall River

    Fall River, Massachusetts, 02721

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • UPMC Cancer Center - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Dickinson County Healthcare System

    Iron Mountain, Michigan, 49801

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network at Southside Cancer Center

    Jacksonville, Florida, 32207

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network

    Jacksonville Beach, Florida, 32250

  • Princeton Radiation Oncology Center

    Jamesburg, New Jersey, 08831

  • UPMC Cancer Center at the John P. Murtha Pavilion

    Johnstown, Pennsylvania, 15901

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Truman Medical Center - Hospital Hill

    Kansas City, Missouri, 64108

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Central Maine Comprehensive Cancer Center at Central Maine Medical Center

    Lewiston, Maine, 04240

  • Central Baptist Hospital

    Lexington, Kentucky, 40503-9985

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • UPMC Cancer Center at UPMC McKeesport

    McKeesport, Pennsylvania, 15132

  • Miami Cancer Center at Mercy Hospital

    Miami, Florida, 33133

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Trinity CancerCare Center

    Minot, North Dakota, 58701

  • Providence Cancer Center at Providence Hospital

    Mobile, Alabama, 36608

  • UPMC - Moon

    Moon Township, Pennsylvania, 15108

  • Cancer Center at Ball Memorial Hospital

    Muncie, Indiana, 47303-3499

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • UPMC Cancer Center - Natrona Heights

    Natrona Heights, Pennsylvania, 15065

  • Jameson Memorial Hospital - North Campus

    New Castle, Pennsylvania, 16105

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453-2699

  • Integrated Community Oncology Network - Orange Park

    Orange Park, Florida, 32073

  • Florida Cancer Center - Palatka

    Palatka, Florida, 32177

  • Bay Medical

    Panama City, Florida, 32401

  • Advocate Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068-1174

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Oncology Hematology Associates of Central Illinois, PC - Peoria

    Peoria, Illinois, 61615

  • UPMC - Shadyside

    Pittsburgh, Pennsylvania, 15213-2582

  • UPMC Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Center at UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • UPMC Cancer Center at UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

  • UPMC Cancer Center at UPMC Passavant

    Pittsburgh, Pennsylvania, 15237

  • UPMC Cancer Center - Upper St. Clair

    Pittsburgh, Pennsylvania, 15243

  • Fitzpatrick Cancer Center at Champlain Valley Physicians Hospital Medical Center

    Plattsburgh, New York, 12901

  • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

    Pomona, California, 91767

  • University Medical Center at Princeton

    Princeton, New Jersey, 08540-3298

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • Lipson Cancer and Blood Center at Rochester General Hospital

    Rochester, New York, 14621

  • University Radiation Oncology at Parkridge Hospital

    Rochester, New York, 14626

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • Flagler Cancer Center

    Saint Augustine, Florida, 32086

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • CCOP - Virginia Mason Research Center

    Seattle, Washington, 98101

  • UPMC Cancer Center at UPMC Northwest

    Seneca, Pennsylvania, 16346

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Mount Nittany Medical Center

    State College, Pennsylvania, 16803

  • Franciscan Cancer Center at St. Joseph Medical Center

    Tacoma, Washington, 98405-3004

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

  • General Robert Huyser Cancer Center at David Grant Medical Center

    Travis Air Force Base, California, 94535-1800

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • UPMC Cancer Center - Uniontown

    Uniontown, Pennsylvania, 15401

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

    Vineland, New Jersey, 08360

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Washington Hospital Cancer Center

    Washington, Pennsylvania, 15301

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Riverview UW Cancer Center at Riverview Hospital

    Wisconsin Rapids, Wisconsin, 54494

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • United States Air Force Medical Center - Wright-Patterson

    Wright-Patterson Air Force Base, Ohio, 45433-5529

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

Other trials in United States

About this study

Official title: Randomized Phase III Trial to Evaluate Radiopharmaceuticals and Zoledronic Acid in the Palliation of Osteoblastic Metastases From Lung, Breast, and Prostate Cancer

RATIONALE: Zoledronate, vitamin D and calcium may prevent or delay bone pain and other symptoms caused by bone metastases. It is not yet known whether giving zoledronate together with vitamin D and calcium is more effective with or without strontium 89 or samarium 153 in treating patients with bone metastases from prostate cancer, lung cancer, or breast cancer.

PURPOSE: This randomized phase III trial is studying zoledronate, vitamin D, and calcium to see how well they work compared to zoledronate, vitamin D, calcium, and either strontium 89 or samarium 153 in preventing or delaying bone problems in patients with bone metastases from prostate cancer, lung cancer, or breast cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the efficacy of zoledronate, vitamin D, and calcium with or without strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium, in terms of preventing or delaying the time to development of malignant skeletal-related events (SREs) (defined as a pathological bone fracture, spinal cord compression, surgery to bone, or radiation to bone) in patients with bone metastases secondary to prostate, lung, or breast cancer.

Secondary

  • Compare the rate of SREs at 1 year in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.
  • Compare quality of life of patients treated with these regimens.
  • Compare the effect of these regimens on pain control in these patients.
  • Evaluate resource utilization and cost effectiveness of these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to primary disease site (prostate vs breast vs lung) and number of bone metastases (≤ 2 vs > 2). Patients are randomized to 1 of 2 treatment arms.

Quality of life and pain are assessed at baseline and then at 1, 3, 6, and 12 months from start of protocol treatment.

After completion of study treatment, patients are followed every 6 months.

Being tested
Calcium, Vitamin D, zoledronic acid, Sm-153, Sr-89
Keywords
pain, bone metastases, extensive stage small cell lung cancer, recurrent breast cancer, stage IV breast cancer, recurrent non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent prostate cancer, stage IV prostate cancer
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Neoplasm Metastasis, Pain, Prostatic Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CalciumDietary supplement

    At least 500 mg of calcium (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.

  • Vitamin DDietary supplement

    400 IU of vitamin D (1 pill) by mouth daily until the study doctor thinks it is in their best interest to stop.

  • zoledronic acidDrug

    Also called Zometa

    4 mg of Zoledronic acid intravenously once a month until the study doctor thinks it is in their best interest to stop.

  • Sm-153Drug

    Also called Samarium-153

    Single dose intravenously 1 mCi/kg body weight.

  • Sr-89Radiation

    Also called Strontium-89

    Single dose intravenously 4 mCi.

Study groups in NCT00365105
Study groupRoleWhat they receive
Zoledronic acidActive comparatorZoledronic acid, vitamin D and calcium supplements.
Receives: Dietary Supplement: Calcium; Dietary Supplement: Vitamin D; Drug: zoledronic acid
Zoledronic acid + RadiopharmaceuticalsExperimentalZoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
Receives: Dietary Supplement: Calcium; Drug: zoledronic acid; Drug: Sm-153; Radiation: Sr-89

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Development of a Malignant Skeletal-related Events (SRE)

    Median time to development of a malignant skeletal related event (SRE), which is defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone is estimated using Kaplan-Meier method. The time of failure was measured from date of randomization to the date of a documented SRE. The analysis was planned to occur after 257 SRE have been observed, unless the criteria for early stopping are met.

    Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 80.1 months.

Secondary outcomes (5)

  1. Number of Patients Experiencing a Skeletal-related Event (SRE) Within One Year

    Skeletal-related events are defined as a pathological bone fracture, spinal cord compression, surgery to bone or radiation to bone.

    Measured: From randomization to 1 year

  2. Overall Survival

    Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

    Measured: From randomization to last follow-up. Maximum follow-up at time of analysis was 101.7 months.

  3. Change in Functional Assessment of Cancer Therapy - General (FACT-G) at One Year

    The FACT-G is a validated 27-item measure in which a higher score represents higher quality of life (QOL). Physical, functional, social and emotional well-being subscale scores are added together to form the FACT-G total score. Responses range from 0=Not a lot to 4=Very much. Certain items must be reversed before being added, by subtracting the response from 4. Subscale items are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Total score ranges from 0-108; physical, social and functional subscales from 0-28; emotional subscale from 0-24. Each subscale requires at least 50% of the items to be completed while the overall response rate must be greater than 80%. If items are missing the subscale scores can be prorated. Change score at one year is calculated as one year score - baseline score with a positive change score indicating improvement in QOL.

    Measured: Baseline and 1 year

  4. Change in Brief Pain Inventory (BPI) at One Year

    The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain. The BPI assesses severity (pain at its "worst," "least," "average," and "now"), and interference (how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep). Patients rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function on a scale of 0 to 10, with 0=no pain/interference and 10=interferes completely/worst pain imaginable.

    Measured: Baseline and 1 year

  5. Change in EuroQol-5 Dimension 3-level (EQ-5D-3L) at One Year

    The EQ-5D-3L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Change at one year is calculated as one-year score - baseline score with positive change indicating improved quality of life.

    Measured: Baseline and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2006 (estimated)
  2. Study start11 Jul 2006
  3. Primary completionJan 2012
  4. Study completion27 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00365105
Sponsor's protocol ID
RTOG 0517
Other IDs
CDR0000491233, NCI-2009-00727
Status last verified
Sep 2024
First submitted
16 Aug 2006
Last updated
20 Sep 2024
Data monitoring committee
Yes

Publications

  • Seider MJ, Pugh SL, Langer C, Wyatt G, Demas W, Rashtian A, Clausen CL, Derdel JD, Cleary SF, Peters CA, Ramalingam A, Clarkson JE, Tomblyn M, Rabinovitch RA, Kachnic LA, Berk LB; NRG Oncology. Randomized phase III trial to evaluate radiopharmaceuticals and zoledronic acid in the palliation of osteoblastic metastases from lung, breast, and prostate cancer: report of the NRG Oncology RTOG 0517 trial. Ann Nucl Med. 2018 Oct;32(8):553-560. doi: 10.1007/s12149-018-1278-4. Epub 2018 Aug 9.

    PubMed 30094545

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calcium, Vitamin D and zoledronic acid in people with Breast Cancer and Lung Cancer, run by Radiation Therapy Oncology Group at 147 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Development of a Malignant Skeletal-related Events (SRE) (time frame: From randomization to last follow-up. Maximum follow-up at time of analysis was 80.1 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00365105, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in