Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Safety and Efficacy of Zoledronic Acid in Patients With Breast Cancer With Metastatic Bone Lesions

9 kwietnia 2012 zaktualizowane przez: Novartis Pharmaceuticals

A Prospective, Randomized, Multi-center Comparative 2-arm Trial of Efficacy and Safety of Zoledronic Acid (Every 3-months vs. Every 4 Weeks) Beyond Approximately 1 Year of Treatment With Zoledronic Acid in Patients With Bone Lesions From Breast Cancer

The objective of this study is to assess the clinical benefit of two different dosing schedules of zoledronic acid in patients with metastatic bone lesions from breast cancer who have already been treated with zoledronic acid for about one year.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

430

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Włochy
      • Forlì, Włochy
        • Novartis Investigative Site

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

Inclusion criteria:

  • Female patients ≥ 18 years of age.
  • Written informed consent given.
  • Histologically confirmed Stage IV breast cancer with at least one bone metastasis radiologically confirmed.
  • Previous treatment with zoledronic acid every 3-4 weeks, for 9-12 infusions over no more than 15 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 .
  • Life expectancy ≥ 1 year.

Exclusion criteria:

  • More than 3 months since last infusion of Zoledronic Acid (Zometa®).
  • Treatments with other bisphosphonate than Zoledronic Acid (Zometa®) at any time prior to study entry.
  • Serum creatinine > 3 mg/dL (265 μmol/L) or calculated (Cockcroft-Gault formula) creatinine clearance (CLCr) < 30 mL/min CrCl = ({[140-age (years)] x weight(kg)}/ [72 x serum creatinine (mg/dL)])x 0.85
  • Corrected (adjusted for serum albumin) serum calcium < 8 mg/dl (2 mmol/L) or > 12 mg/dL ( 3.0 mmol/L).
  • Current active dental problem including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a recurrent or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
  • Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants).
  • Pregnant patients (with a positive pregnancy test prior to study entry) or lactating patients. Women of childbearing potential not using effective methods of birth control (e.g. abstinence, oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide).
  • History of non-compliance to medical regimens or potential unreliable behavior.
  • Known sensitivity to study drug(s) or class of study drug(s).
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Use of any other investigational agent in the last 30 days.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Every 3 months
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every three months. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized patients will receive a maximum of 4 infusions in this group.
Lek: Zoledronic acid
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg.
Inne nazwy:
  • ZOL446
  • Zometa®
Eksperymentalny: Every 4 weeks
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion every 4 weeks. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Patients randomized to this group will receive up to 12 infusions.
Lek: Zoledronic acid
Zoledronic acid as a 15-minute (at least) intravenous (i.v.) infusion. The dose of study drug will be the same administered before the study entry, that is 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg.
Inne nazwy:
  • ZOL446
  • Zometa®

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Annual Overall Skeletal Morbidity Rate (SMR)
Ramy czasowe: 12 months

The SMR was computed by summing all Skeletal Related Event(s) (SREs)which occurred during the observation period and dividing it by the ratio "days of observation period / 365.25", for each participant. SRE was defined as: pathologic bone fracture, spinal cord compression, surgery to bone both curative and prophylactic, radiation therapy to bone, or hypercalcemia of malignancy.

SMR (years) = 365.25 x SMR(days) where SMR (days) = total number of SREs / total SRE risk period (days). Risk period for SMR was computed as the days from randomization date to the date of last visit.
12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants Experiencing Skeletal Related Event(s) (SREs)
Ramy czasowe: 12 month

Skeletal Related Events (SREs) are defined as a:

  • pathologic bone fracture such as non-vertebral and vertebral compression fractures
  • spinal cord compression identified by positive diagnosis documented by X-ray evidence
  • surgery to bone both curative and prophylactic
  • radiation therapy to bone including palliative, therapeutic or prophylactic
  • hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration.
12 month
Annual Incidence of Any Skeletal Related Events (SREs)
Ramy czasowe: 12 months

Skeletal Related Events (SREs) are defined as a:

  • pathologic bone fracture such as non-vertebral and vertebral
  • spinal cord compression identified by X-rays evidence
  • surgery to bone both curative and prophylactic
  • radiation therapy to bone including palliative, therapeutic or prophylactic
  • hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level of hypercalcemia which is symptomatic and which requires active treatment other than rehydration. Annual incidence for each SRE was computed in the same way as annual overall SMR.
12 months
Median Time to First Skeletal Related Event(s) (SRE)
Ramy czasowe: 12 month
Median Time to first skeletal related event (SRE) is defined as the time from randomization to the date of first occurrence of any SRE which includes at least one of the following: radiation therapy to bone, pathologic bone fracture, spinal cord compression, surgery to bone, and hypercalcemia of malignancy (HCM). Due to the few numbers of SRE, Kaplan-Meier estimate never reaches a failure probability >=25%; so median time, 25th and 75th percentiles are not determined.For this reason only the estimated percentage of patient SRE free are reported at each time point.
12 month
Percentage of Participants Skeletal Related Event (SRE) Free
Ramy czasowe: 12 months

Percentage of participants SRE free is defined as the Kaplan-Meier estimate of participants free of any Skeletal Related Events(SRE) at each time point.

Skeletal Related Events (SREs) are:

  • pathologic bone fracture; non-vertebral and vertebral
  • spinal cord compression identified by X-rays
  • surgery to bone both curative and prophylactic
  • radiation therapy to bone (palliative, therapeutic or prophylactic)
  • hypercalcemia of malignancy, defined as a corrected serum calcium > 12 mg/dl (3.00 mmol/l) or a lower level which is symptomatic and requires treatment other than rehydration.
12 months
Composite Bone Pain Score According to the Brief Pain Inventory (BPI) Questionnaire
Ramy czasowe: At Baseline, Month 3, Month 6, Month 9 and Month 12
Bone pain was assessed by means of a pain score obtained using the Brief Pain Inventory (BPI) questionnaire. The BPI can produce three pain scores: worst pain, a composite pain score, and a pain interference score. The composite pain score, which is the average of questions 3, 4, 5 and 6 of the questionnaire was used in this study. Pain was rated on a scale of 0 (no pain) to 10 (pain as bad as you can imagine). The outcome is given as the median score for participants at baseline, and 3, 6, 9 and 12 months of treatment
At Baseline, Month 3, Month 6, Month 9 and Month 12
Evaluation of Pain According to Verbal Rating Scale (VRS) Based on Median Score Value
Ramy czasowe: At Baseline, Month 3, Month 6, Month 9 and Month 12
Pain intensity at rest and on movement is rated by the patient by means of a validated 6-point Verbal Rating Scale (VRS) and refers to the pain which occurred during the last week before the assessment. Median score value is the median of all the observed scores (none=0, very mild=1, mild=2, moderate=3, severe=5 and very severe=6) at each time point.
At Baseline, Month 3, Month 6, Month 9 and Month 12
Use Of Analgesic Medications According to the Analgesic Score Scale
Ramy czasowe: At Baseline, Month 3, Month 6, Month 9 and Month 12

The analgesic score used for this study is modified from the Radiation Therapy Oncology Group (RTOG) analgesic score scale. The scale represents type of medication administered from 0 to 4 where:

0 = None

  1. = Minor analgesics (aspirin, NSAID, acetaminophen, propoxyphene, etc.)
  2. = Tranquilisers, antidepressants, muscle relaxants, and steroids
  3. = Mild narcotics (oxycodone, meperidine, codeine, etc.)
  4. = Strong narcotics (morphine, hydromorphone, etc.) The outcome is given a the median score for the participants at Baseline and 3, 6, 9 and 12 months of treatment
At Baseline, Month 3, Month 6, Month 9 and Month 12
Assessment of the Eastern Cooperative Oncology Group (ECOG) Performance Score
Ramy czasowe: At Baseline, Month 3, Month 6, Month 9 and Month 12
ECOG Performance Score has 4 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. Outcome is given as median score for participants at Baseline and 3, 6 , 9 and 12 months of treatment
At Baseline, Month 3, Month 6, Month 9 and Month 12

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Novartis Pharmaceuticals

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lutego 2006

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2010

Daty rejestracji na studia

Pierwszy przesłany

12 września 2006

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 września 2006

Pierwszy wysłany (Oszacować)

13 września 2006

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

11 kwietnia 2012

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 kwietnia 2012

Ostatnia weryfikacja

1 lipca 2011

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CZOL446EIT14

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zoledronic acid

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in El Salvador

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

3
Subskrybuj