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OsteoporosisPhase 3NCT00329797

Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy

A Phase 3 study testing Calcium, Zoledronic acid and radiation therapy in people with Osteoporosis and Prostate Cancer, run by Radiation Therapy Oncology Group at 88 sites in 2 countries.

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 may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Osteoporosis, Prostate Cancer
What is being tested?
Calcium, Zoledronic acid and radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
109 participants
Where
88 sitesin 2 countries
Study dates
Mar 2006to Nov 2014
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Eligibility criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 12 months of registration;
  • Any one of the following clinical stages:
  • T3 disease, any N stage, M0 with any Gleason score and any prostate-specific antigen (PSA); < T3 stage, any N stage, M0 with Gleason's score ≥ 8 and any PSA; < T3 stage, any N stage, M0 with Gleason's score 7 and PSA ≥ 15 nanograms/ml; < T3 stage, any N stage, M0 with Gleason score < 7 and PSA ≥ 20 nanograms/ml.
  • A negative bone scan for metastatic disease;
  • It is mandatory that the treating physician determine the planned duration of LHRH therapy prior to the site registering the patient (minimum 1 year of therapy); If patient is receiving pre-treatment LHRH therapy, it must have begun ≤ 6 months prior to registration. If pelvic radiation therapy (RT) has started, it must have begun ≤ 8 weeks prior to registration;
  • Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup to be done within 16 weeks prior to registration:
  • History/physical examination;
  • Dental evaluation, including history of dental surgery (e.g., extraction or implant);
  • Bone scan;
  • T and L spine films;
  • DXA scan: To be eligible the patient must have a scan on Lunar, Hologic, or Norland equipment only and the T scores in both the L spine and total hip must be > negative 2.5;
  • Zubrod Performance Status 0-1 within 16 weeks prior to registration; (8/16/07)
  • Age ≥ 18;
  • Serum creatinine within 4 weeks prior to registration (8/16/07)
  • Corrected serum calcium ≥ 8.4 and ≤ 10.6 mg/dl within 8 weeks prior to registration; note: for patients with an albumin of 4.0, corrected calcium=measured calcium. The formula for corrected calcium if serum albumin value is above or below 4.0 is as follows: Corrected calcium (mg/dl) = (4 - [patient's albumin (g/dl)] x 0.8) + patient's measured calcium (mg/dl)
  • Patients who are sexually active must be willing/able to use medically acceptable forms of contraception, as the treatment involved in this study may be significantly teratogenic.
  • Patient agrees to refrain from using all products listed in Section 9.2, "Non-permitted Supportive Therapy";
  • Post-prostatectomy patients are eligible.
  • Patient must sign study specific informed consent prior to study entry.

Ineligibility criteria:

  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; e.g., carcinoma in situ of the breast or oral cavity are permissible;
  • Patients with baseline T scores of ≤ -2.5 are excluded.
  • Patients with baseline calculated creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault formula below) are excluded. creatinine clearance male = [(140 - age) x (wt in kg)] / [(serum creatinine) x (72)]
  • Prior bisphosphonate therapy;
  • Prior pelvic radiation (other than for current prostate cancer) or prior systemic radiotherapeutic agents, such as strontium or samarium;
  • Patients receiving systemic chemotherapy, steroids, growth hormones, or calcitonin;
  • Patients with a history of Paget's disease or with uncontrolled thyroid or parathyroid dysfunction or with other diseases that influence bone metabolism;
  • Known hypersensitivity to zoledronic acid or other bisphosphonates;
  • Active dental problems at study entry, including infection of the teeth or jawbone; dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures;
  • Recent or planned

Trial locations and contacts

88 sites in 2 countries.

88 sites in 2 countries

United States80 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

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • 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

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Lourdes Regional Cancer Center

    Binghamton, New York, 13905

  • Veterans Affairs Medical Center - Brooklyn

    Brooklyn, New York, 11209

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Cancer Institute of New Jersey at Cooper University Hospital - Camden

    Camden, New Jersey, 08103

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Enloe Cancer Center at Enloe Medical Center

    Chico, California, 95926

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • CCOP - Hematology-Oncology Associates of Central New York

    East Syracuse, New York, 13057

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • 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

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Methodist Cancer Center at Methodist Hospital

    Indianapolis, Indiana, 46202

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Kingsbury Center for Cancer Care at Cheshire Medical Center

    Keene, New Hampshire, 03431

  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37662

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Community Memorial Hospital Cancer Care Center

    Menomonee Falls, Wisconsin, 53051

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • Sentara Cancer Institute at Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields

    Olympia Fields, Illinois, 60461

  • Cancer Center of Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301-1792

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

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

    Pomona, California, 91767

  • Naval Medical Center - Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • St. Mary - Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • Cancer Centers of North Carolina - Raleigh

    Raleigh, North Carolina, 27607

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Norris Cotton Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

    Salem, Ohio, 44460

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • 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

  • West Allis Memorial Hospital

    West Allis, Wisconsin, 53227

  • Precision Radiotherapy at University Pointe

    West Chester, Ohio, 45069

  • Wilmed Radiation Oncology Services

    Wilson, North Carolina, 27893

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

  • 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

Canada8 sites

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Centre Hospitalier Universitaire de Quebec

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • CHUS-Hopital Fleurimont

    Sherbrooke, Quebec, J1H 5N4

  • Doctor H. Bliss Murphy Cancer Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Cancer Care Program at Thunder Bay Regional Health Sciences

    Thunder Bay, Ontario, P7B 6V4

  • British Columbia Cancer Agency - Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

About this study

Official title: A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer.

PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus vitamin D and calcium supplement vs standard therapy with vitamin D and calcium supplement in the prevention of osteoporosis and associated bone fractures in patients with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing radiotherapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy.

Secondary

  • Evaluate the potential benefit of these regimens on quality of life in these patients.
  • Evaluate the potential benefit in bone mineral density over a period of 3 years for patients treated with these regimens.

OUTLINE: This is randomized multicenter study. Patients are stratified according to T score of the hip by dual x-ray absorptiometry (DXA) scan (< -1.0 but > -2.5 vs ≥ - 1.0) and planned duration of luteinizing hormone-releasing hormone (LHRH) agonist therapy (1-2½ years vs > 2½ years). Patients are randomized to 1 of 2 treatment arms.

Quality of life is assessed at baseline and every 6 months during treatment.

Being tested
Calcium, Zoledronic acid, radiation therapy, LHRH, Vitamin D
Keywords
osteoporosis, adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
Medical subject headings
Osteoporosis, Prostatic Neoplasms

What participants receive

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

  • CalciumDietary supplement

    A single dose of 500 mg of elemental calcium orally each day for 3 years.

  • Zoledronic acidDietary supplement

    Also called Zometa, zoledronate

    Patients receive IV over 15 minutes once every 6 months for 3 years. The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.

  • radiation therapyRadiation

    Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.

  • LHRHDrug

    LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.

  • Vitamin DDietary supplement

    400 IU (10μg), orally each day for 3 years.

Study groups in NCT00329797
Study groupRoleWhat they receive
Zoledronic AcidExperimentalZoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Receives: Dietary Supplement: Calcium; Dietary Supplement: Zoledronic acid; Radiation: radiation therapy; Drug: LHRH; Dietary Supplement: Vitamin D
ControlActive comparatorVitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Receives: Dietary Supplement: Calcium; Radiation: radiation therapy; Drug: LHRH; Dietary Supplement: Vitamin D

What is being measured

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

  1. Freedom From Any Bone Fracture (FABF) Rate at Three Years

    The time of failure was measured from the date of randomization to the date of documented bone fractures, defined as any fracture of the bone. The three-year FABF rate will be estimated by the Kaplan-Meier method.

    Measured: From randomization to 3 years

Secondary outcomes (3)

  1. Percent Change in Bone Mineral Density at 3 Years

    Bone mineral density (BMD) was measured by DXA scan (Dual X-ray absorptiometry) for five locations: lumbar, right total hip, left total hip, right femoral neck, and left femoral neck. The percent change at 3 years was calculated for each location by the following formula: Percent Change BMD = (BMD_3 years - BMD_Baseline)/ BMD_Baseline * 100.

    Measured: Baseline, 3 years from start of treatment

  2. Changes in the Functional Assessment of Cancer Therapy-General (FACT-G) at 3 Years

    The FACT-G is a validated, 27-item measure. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together, multiplied by the number of items in the subscale, then divided by the number of items answered to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for the physical, social and functional subscales, and 0-24 for the emotional subscale. Certain items, identified on the FACT-G scoring guides, must be reversed before it is added by subtracting the response from 4. All subscale totals are added together to form the FACT-G total score. 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. A higher score indicates better QOL.

    Measured: Baseline, 3 years from start of treatment

  3. Utility of the Use of Bisphosphonates as Assessed by Quality-adjusted Survival

    The EQ-5D is a standardized instrument for measuring generic health status used to generate health utilities, used to derive quality adjusted survival. Quality adjusted survival is computed using the weighted sum of times in different health states added up to a total quality-adjusted survival time. The log-rank test is used to compare quality-adjusted survivals between the treatment arms.

    Measured: From pre-treatment to 3 years from start of treatment

Timeline

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

  1. First posted25 May 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionNov 2014
  4. Study completionNov 2014

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
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00329797
Sponsor's protocol ID
RTOG 0518
Other IDs
CDR0000476469, NCI-2009-00884
Status last verified
Oct 2017
First submitted
23 May 2006
Last updated
29 Nov 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calcium, Zoledronic acid and radiation therapy in people with Osteoporosis and Prostate Cancer, run by Radiation Therapy Oncology Group at 88 sites in 2 countries.

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

Who may be eligible to take part?

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 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, Canada. 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 29 Nov 2017). 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?

Freedom From Any Bone Fracture (FABF) Rate at Three Years (time frame: From randomization to 3 years). 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 NCT00329797.

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 29 Nov 2017.

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