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

23. Oktober 2017 aktualisiert von: Radiation Therapy Oncology Group

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

109

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • British Columbia
      • Victoria, British Columbia, Kanada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Centre
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Kanada, A1B 3V6
        • Doctor H. Bliss Murphy Cancer Centre
    • Ontario
      • Hamilton, Ontario, Kanada, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Thunder Bay, Ontario, Kanada, P7B 6V4
        • Cancer Care Program at Thunder Bay Regional Health Sciences
    • Quebec
      • Montreal, Quebec, Kanada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Quebec City, Quebec, Kanada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
      • Sherbrooke, Quebec, Kanada, J1H 5N4
        • CHUS-Hopital Fleurimont
    • Saskatchewan
      • Regina, Saskatchewan, Kanada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
  • Vereinigte Staaten
    • California
      • Chico, California, Vereinigte Staaten, 95926
        • Enloe Cancer Center at Enloe Medical Center
      • Los Angeles, California, Vereinigte Staaten, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Pomona, California, Vereinigte Staaten, 91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Roseville, California, Vereinigte Staaten, 95661
        • Radiation Oncology Center - Roseville
      • Sacramento, California, Vereinigte Staaten, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
    • Colorado
      • Colorado Springs, Colorado, Vereinigte Staaten, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Pueblo, Colorado, Vereinigte Staaten, 81004
        • St. Mary - Corwin Regional Medical Center
    • Georgia
      • Gainesville, Georgia, Vereinigte Staaten, 30501
        • Northeast Georgia Medical Center
    • Illinois
      • Alton, Illinois, Vereinigte Staaten, 62002
        • Saint Anthony's Hospital at Saint Anthony's Health Center
      • Arlington Heights, Illinois, Vereinigte Staaten, 60005
        • Northwest Community Hospital
      • Harvey, Illinois, Vereinigte Staaten, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Olympia Fields, Illinois, Vereinigte Staaten, 60461
        • Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
      • Urbana, Illinois, Vereinigte Staaten, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Goshen, Indiana, Vereinigte Staaten, 46526
        • Center for Cancer Care at Goshen General Hospital
      • Indianapolis, Indiana, Vereinigte Staaten, 46202
        • Methodist Cancer Center at Methodist Hospital
    • Kentucky
      • Lexington, Kentucky, Vereinigte Staaten, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, Vereinigte Staaten, 21229
        • St. Agnes Hospital Cancer Center
    • Michigan
      • Detroit, Michigan, Vereinigte Staaten, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit, Michigan, Vereinigte Staaten, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Kalamazoo, Michigan, Vereinigte Staaten, 49007-3731
        • West Michigan Cancer Center
    • Minnesota
      • Saint Cloud, Minnesota, Vereinigte Staaten, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, Vereinigte Staaten, 56303
        • Coborn Cancer Center
    • Missouri
      • Cape Girardeau, Missouri, Vereinigte Staaten, 63701
        • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
      • Kansas City, Missouri, Vereinigte Staaten, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, Vereinigte Staaten, 63141
        • CCOP - St. Louis-Cape Girardeau
      • Saint Louis, Missouri, Vereinigte Staaten, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Saint Louis, Missouri, Vereinigte Staaten, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • Springfield, Missouri, Vereinigte Staaten, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Vereinigte Staaten, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Vereinigte Staaten, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Vereinigte Staaten, 59101
        • Northern Rockies Radiation Oncology Center
      • Great Falls, Montana, Vereinigte Staaten, 59405
        • Great Falls Clinic - Main Facility
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89106
        • CCOP - Nevada Cancer Research Foundation
      • Reno, Nevada, Vereinigte Staaten, 89502
        • Renown Institute for Cancer at Renown Regional Medical Center
    • New Hampshire
      • Keene, New Hampshire, Vereinigte Staaten, 03431
        • Kingsbury Center for Cancer Care at Cheshire Medical Center
      • Lebanon, New Hampshire, Vereinigte Staaten, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, Vereinigte Staaten, 08103
        • Cancer Institute of New Jersey at Cooper University Hospital - Camden
      • Vineland, New Jersey, Vereinigte Staaten, 08360
        • Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
      • Voorhees, New Jersey, Vereinigte Staaten, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • Binghamton, New York, Vereinigte Staaten, 13905
        • Lourdes Regional Cancer Center
      • Brooklyn, New York, Vereinigte Staaten, 11209
        • Veterans Affairs Medical Center - Brooklyn
      • Buffalo, New York, Vereinigte Staaten, 14263-0001
        • Roswell Park Cancer Institute
      • East Syracuse, New York, Vereinigte Staaten, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Asheville, North Carolina, Vereinigte Staaten, 28801
        • Mission Hospitals - Memorial Campus
      • Goldsboro, North Carolina, Vereinigte Staaten, 27534
        • Wayne Radiation Oncology
      • Raleigh, North Carolina, Vereinigte Staaten, 27607
        • Cancer Centers of North Carolina - Raleigh
      • Wilson, North Carolina, Vereinigte Staaten, 27893
        • Wilmed Radiation Oncology Services
    • Ohio
      • Akron, Ohio, Vereinigte Staaten, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Akron, Ohio, Vereinigte Staaten, 44309-2090
        • Summa Center for Cancer Care at Akron City Hospital
      • Cincinnati, Ohio, Vereinigte Staaten, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Salem, Ohio, Vereinigte Staaten, 44460
        • Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
      • West Chester, Ohio, Vereinigte Staaten, 45069
        • Precision Radiotherapy at University Pointe
      • Wooster, Ohio, Vereinigte Staaten, 44691
        • Cancer Treatment Center
    • Pennsylvania
      • Abington, Pennsylvania, Vereinigte Staaten, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Bryn Mawr, Pennsylvania, Vereinigte Staaten, 19010
        • Bryn Mawr Hospital
      • Gettysburg, Pennsylvania, Vereinigte Staaten, 17325
        • Adams Cancer Center
      • Paoli, Pennsylvania, Vereinigte Staaten, 19301-1792
        • Cancer Center of Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Wynnewood, Pennsylvania, Vereinigte Staaten, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • York, Pennsylvania, Vereinigte Staaten, 17405
        • York Cancer Center at Apple Hill Medical Center
    • Tennessee
      • Kingsport, Tennessee, Vereinigte Staaten, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
    • Utah
      • Murray, Utah, Vereinigte Staaten, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, Vereinigte Staaten, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, Vereinigte Staaten, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Vereinigte Staaten, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Vereinigte Staaten, 84143
        • LDS Hospital
    • Vermont
      • Saint Johnsbury, Vermont, Vereinigte Staaten, 05819
        • Norris Cotton Cancer Center - North
    • Virginia
      • Norfolk, Virginia, Vereinigte Staaten, 23507
        • Sentara Cancer Institute at Sentara Norfolk General Hospital
      • Portsmouth, Virginia, Vereinigte Staaten, 23708-2197
        • Naval Medical Center - Portsmouth
    • Washington
      • Yakima, Washington, Vereinigte Staaten, 98902
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
    • Wisconsin
      • Appleton, Wisconsin, Vereinigte Staaten, 54911
        • Theda Care Cancer Institute
      • Green Bay, Wisconsin, Vereinigte Staaten, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Marinette, Wisconsin, Vereinigte Staaten, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Menomonee Falls, Wisconsin, Vereinigte Staaten, 53051
        • Community Memorial Hospital Cancer Care Center
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53226
        • Medical College of Wisconsin Cancer Center
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53295
        • Veterans Affairs Medical Center - Milwaukee
      • Milwaukee, Wisconsin, Vereinigte Staaten, 53215
        • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
      • West Allis, Wisconsin, Vereinigte Staaten, 53227
        • West Allis Memorial Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Männlich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Zoledronic Acid
Zoledronic acid q 6 months plus Vitamin D and calcium supplement for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Nahrungsergänzungsmittel: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Nahrungsergänzungsmittel: Zoledronic acid
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.
Andere Namen:
  • Zometa
  • Zoledronat
Strahlung: radiation therapy
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.
Arzneimittel: LHRH
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.
Nahrungsergänzungsmittel: Vitamin D
400 IU (10μg), orally each day for 3 years.
Aktiver Komparator: Control
Vitamin D and calcium supplement everyday for 3 years in addition to concurrent radiation therapy and LHRH therapy.
Nahrungsergänzungsmittel: Calcium
A single dose of 500 mg of elemental calcium orally each day for 3 years.
Strahlung: radiation therapy
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.
Arzneimittel: LHRH
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.
Nahrungsergänzungsmittel: Vitamin D
400 IU (10μg), orally each day for 3 years.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Freedom From Any Bone Fracture (FABF) Rate at Three Years
Zeitfenster: From randomization to 3 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.
From randomization to 3 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percent Change in Bone Mineral Density at 3 Years
Zeitfenster: Baseline, 3 years from start of treatment
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.
Baseline, 3 years from start of treatment
Changes in the Functional Assessment of Cancer Therapy-General (FACT-G) at 3 Years
Zeitfenster: Baseline, 3 years from start of treatment
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.
Baseline, 3 years from start of treatment
Utility of the Use of Bisphosphonates as Assessed by Quality-adjusted Survival
Zeitfenster: From pre-treatment to 3 years from start of treatment
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.
From pre-treatment to 3 years from start of treatment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Radiation Therapy Oncology Group

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Colleen A. Lawton, MD, Medical College of Wisconsin
  • Studienstuhl: Matthew R. Smith, MD, Massachusetts General Hospital
  • Studienstuhl: Margaret Chamberlain-Wilmoth, PhD, MSS, RN, Carolinas Medical Center - University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. März 2006

Primärer Abschluss (Tatsächlich)

1. November 2014

Studienabschluss (Tatsächlich)

1. November 2014

Studienanmeldedaten

Zuerst eingereicht

23. Mai 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. Mai 2006

Zuerst gepostet (Schätzen)

25. Mai 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. November 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

23. Oktober 2017

Zuletzt verifiziert

1. Oktober 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RTOG 0518
  • CDR0000476469
  • NCI-2009-00884 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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