Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis
29 kwietnia 2008 zaktualizowane przez: Eli Lilly and Company
Effects of LY333334 in the Treatment of Postmenopausal Women With Osteoporosis
The primary objective of this study is to demonstrate a reduction in the proportion of new vertebral fractures in postmenopausal women with osteoporosis following 3-years of treatment with 20 and 40 mcg/day of teriparatide plus calcium and vitamin D compared with calcium and vitamin D alone.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1637
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Capital Federal, Argentyna
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Nedlands, Australia
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Graz, Austria
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Brussels, Belgia
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Aarhus, Dania
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Kuopio, Finlandia
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Amsterdam, Holandia
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Tel-Hashomer, Izrael
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Alberta
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Calgary, Alberta, Kanada
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Kristiansand, Norwegia
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Christchurch, Nowa Zelandia
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Warszawa, Polska
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Praha, Republika Czeska
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
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Uppsala, Szwecja
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Szeged, Węgry
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Arenzano, Włochy
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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
30 lat do 85 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
Inclusion Criteria:
- Ambulatory, postmenopausal women.
- A minimum of either one moderate or two mild atraumatic vertebral fractures, and a minimum of seven evaluable nonfractured vertebrae.
- Hip BMD or lumbar spine BMD measurement at least 1.0 standard deviation (SD) below the average bone mass for young, healthy women (T-score) only in patients with fewer than two moderate fractures or in patients previously treated with therapeutic doses of bisphosphonates or fluorides
- Normal or clinically nonsignificant abnormal laboratory values (serum calcium, PTH(1-84), & urine calcium must be within normal limits at baseline; 25-hydroxyvitamin D must be between the lower limit of normal & 3 times the upper limit of normal at baseline).
Exclusion Criteria:
- Fractures in areas of bone affected by diseases other than osteoporosis (for example, cancer or Paget's disease).
- Satisfactory baseline thoracic and lumbar spinal x-ray views cannot be obtained as determined by the centralized x-ray quality assurance center (for example, severe scoliosis or kyphosis).
- Current or recent (within 1 year prior to randomization) metabolic bone disorders other than postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, or any secondary causes of osteoporosis
- Current or recent (within 1 year prior to randomization) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
- Currently suspected carcinoma or history of carcinoma in the 5 years prior to randomization.
- Nephrolithiasis or urolithiasis in the 2 years prior to randomization.
- Current or recent (within 1 year prior to randomization) sprue, inflammatory bowel disease, or malabsorption syndrome, or any indication of poor intestinal absorption of calcium, such as the combination of a low urinary calcium excretion and an elevated serum intact parathyroid hormone level.
- Poor medical or psychiatric risk for treatment with an investigational drug, in the opinion of the investigator.
- Treatment with androgens or other anabolic steroids in the 6 months prior to randomization.
- Treatment with calcitonins in the 2 months prior to randomization.
- Treatment with estrogen
- Treatment with progestins in the 3 calendar months prior to randomization, or for more than 2 months in the 12 calendar months prior to randomization.
- Treatment with corticosteroids.
- Treatment with fluorides in the 6 months prior to randomization or for more than 60 days in the 24 months prior to randomization.
- Treatment with oral bisphosphonates in the 3 months prior to randomization or for more than 60 days in the 24 months prior to randomization; treatment with intravenous bisphosphonates in the 24 months prior to randomization.
- Treatment with vitamin D >50,000 IU/week, or with any dose of calcitriol, analogs, or agonists in the 6 months prior to randomization. The 25-hydroxyvitamin D laboratory value at randomization must be between the lower limit of normal and three times the upper limit of normal.
- Treatment with coumarins and indandione derivatives in the 3 months prior to randomization; treatment with heparins >10,000 U/day for more than 30 days in the 6 months prior to randomization.
- Treatment with calcium- or aluminum-containing antacids
- Treatment with any other drug known to affect bone metabolism in the 6 months prior to randomization.
- Treatment with any investigational drug during the month prior to the calcium and vitamin D run-in phase. Treatment with investigational drugs in certain therapeutic classes during the month prior to the calcium & vitamin D run-in phase.
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: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 1
LY333334 40 micrograms/day plus calcium and vitamin D
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40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Inne nazwy:
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Inne nazwy:
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
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Eksperymentalny: 2
LY333334 20 micrograms/day plus calcium and vitamin D
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40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Inne nazwy:
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Inne nazwy:
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
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Komparator placebo: 3
Placebo plus calcium and vitamin D
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Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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To demonstrate a reduction in the proportion of patients with new vertebral fractures (by spinal x-ray) following 3-year treatment with 20 and 40 micrograms/day of LY333334 plus calcium and vitamin D compared with calcium and vitamin D alone.
Ramy czasowe: Baseline, randomization, 24 , 36, and 60 months
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Baseline, randomization, 24 , 36, and 60 months
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on lumbar spine and hip BMD in postmenopausal women with osteoporosis
Ramy czasowe: Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
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Lumbar Spine: Randomization -2wks, Randomization,( 3 & 6 months in a subset of pts), 12 , 18 , 24 , 36 , 48 & 60 months. Hip BMD: Randomization -2wks, Randomization, 12 , 24 , 36 , 48 & 60 months.
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To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on total body and radial (forearm) BMD in postmenopausal women with osteoporosis at selected study sites
Ramy czasowe: Randomization, 12, 24, 36, 48 and 60 months
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Randomization, 12, 24, 36, 48 and 60 months
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To establish the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on the rate of new vertebral fractures (by spinal x-ray) in postmenopausal women with osteoporosis.
Ramy czasowe: Baseline, randomization, 24 months, 60 months
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Baseline, randomization, 24 months, 60 months
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To establish the effect of treatment with LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, by x-ray on the proportion of subjects experiencing new nonvertebral fractures alone & new nonvertebral & vertebral fractures combined.
Ramy czasowe: As clinically needed throughout the trial
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As clinically needed throughout the trial
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To assess the effect of long-term treatment with LY333334 plus calcium and vitamin D, compared with calcium and vitamin D alone, on height (via Harpenden stadiometer or other suitable stadiometer) in postmenopausal women with osteoporosis
Ramy czasowe: Randomization, 12, 24, 36, 48, and 60 months
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Randomization, 12, 24, 36, 48, and 60 months
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To determine the histomorphometric effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone by biopsy, on the iliac crest (bone formation & resorption, mineralization, and trabecular structure) in a subset of subjects.
Ramy czasowe: Randomization, 12 and 24 months
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Randomization, 12 and 24 months
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To assess effects of LY333334 plus calcium & vitamin D, compared with calcium & vitamin D alone, on biochemical markers of bone formation & resorption (bone-specific alkaline phosphatase, PICP, urinary N-telopeptide, & urinary free deoxypyridinolines)
Ramy czasowe: Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
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Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
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To assess population pharmacokinetics of LY333334 at selected study sites. Nonlinear mixed effect modeling [NONMEM])and or PTH(1-84) will be employed to evaluate serum concentrations of LY333334.
Ramy czasowe: Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
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Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
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To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.
Ramy czasowe: Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
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Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
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To assess the impact of LY333334 on health-related quality of life in postmenopausal women with osteoporosis. Quality of life instruments will be completed where translated and validated instruments are available.
Ramy czasowe: Randomization, 12, 24, 36, 48, and 60 months
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Randomization, 12, 24, 36, 48, and 60 months
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To establish the safety of chronic administration of LY333334 in postmenopausal women with osteoporosis. Adverse events, physical examinations and laboratory tests will be used to assess safety in the patients.
Ramy czasowe: Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months
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Adverse Events: throughout the trial. Labs:Baseline, randomization, 1, 6, 12, 24, 36, 48, and 60 months. Physical Exams: 12, 24, 36, 48, and 60 months
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Call 1-877-CT LILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
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 sierpnia 1996
Zakończenie podstawowe (Rzeczywisty)
1 kwietnia 1999
Ukończenie studiów (Rzeczywisty)
1 kwietnia 1999
Daty rejestracji na studia
Pierwszy przesłany
29 kwietnia 2008
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 kwietnia 2008
Pierwszy wysłany (Oszacować)
1 maja 2008
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
1 maja 2008
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 kwietnia 2008
Ostatnia weryfikacja
1 kwietnia 2008
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 547
- B3D-MC-GHAC
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 .