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Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

29. April 2008 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

1637

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

  • Argentinien
      • Capital Federal, Argentinien
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Australien
      • Nedlands, Australien
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Belgien
      • Brussels, Belgien
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Dänemark
      • Aarhus, Dänemark
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Finnland
      • Kuopio, Finnland
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Israel
      • Tel-Hashomer, Israel
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Italien
      • Arenzano, Italien
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Neuseeland
      • Christchurch, Neuseeland
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Niederlande
      • Amsterdam, Niederlande
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Norwegen
      • Kristiansand, Norwegen
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Polen
      • Warszawa, Polen
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Schweden
      • Uppsala, Schweden
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Tschechische Republik
      • Praha, Tschechische Republik
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Ungarn
      • Szeged, Ungarn
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Vereinigte Staaten
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02114
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Österreich
      • Graz, Österreich
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

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

30 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 1
LY333334 40 micrograms/day plus calcium and vitamin D
Arzneimittel: teriparatide
40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Andere Namen:
  • Forteo
  • LY333334
  • Forsteo
Arzneimittel: teriparatide
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Andere Namen:
  • Forteo
  • LY333334
  • Forsteo
Arzneimittel: Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Arzneimittel: Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Experimental: 2
LY333334 20 micrograms/day plus calcium and vitamin D
Arzneimittel: teriparatide
40 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Andere Namen:
  • Forteo
  • LY333334
  • Forsteo
Arzneimittel: teriparatide
20 micrograms/day subcutaneous injection for 3 years with optional 2 year extension phase
Andere Namen:
  • Forteo
  • LY333334
  • Forsteo
Arzneimittel: Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Arzneimittel: Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Placebo-Komparator: 3
Placebo plus calcium and vitamin D
Arzneimittel: Calcium Supplement
Approximately 1000 mg/day of elemental calcium will be supplied as open-label oral supplement
Arzneimittel: Vitamin D Supplement
Approximately 400 to 1200 IU/day of vitamin D will be supplied as open-label oral supplement
Arzneimittel: Placebo
Placebo for subcutaneous injection will be supplied in a prefilled injection device with a cartridge identical in appearance to the LY333334 device.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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.
Zeitfenster: Baseline, randomization, 24 , 36, and 60 months
Baseline, randomization, 24 , 36, and 60 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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
Zeitfenster: 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.
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.
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
Zeitfenster: Randomization, 12, 24, 36, 48 and 60 months
Randomization, 12, 24, 36, 48 and 60 months
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.
Zeitfenster: Baseline, randomization, 24 months, 60 months
Baseline, randomization, 24 months, 60 months
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.
Zeitfenster: As clinically needed throughout the trial
As clinically needed throughout the trial
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
Zeitfenster: Randomization, 12, 24, 36, 48, and 60 months
Randomization, 12, 24, 36, 48, and 60 months
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.
Zeitfenster: Randomization, 12 and 24 months
Randomization, 12 and 24 months
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)
Zeitfenster: Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
Randomization, 1, 3, 6, 12, 24, 36, 48, and 60 months
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.
Zeitfenster: Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
Months 1, 3, 6, 12, 18, 24, 30, 36 and 60
To quantify medical resources used by patients during the study so that a cost-effectiveness analysis can be performed.
Zeitfenster: Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
Randomization, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 Months
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.
Zeitfenster: Randomization, 12, 24, 36, 48, and 60 months
Randomization, 12, 24, 36, 48, and 60 months
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.
Zeitfenster: 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
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

Mitarbeiter und Ermittler

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

Sponsor

Eli Lilly and Company

Ermittler

  • Studienleiter: 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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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. August 1996

Primärer Abschluss (Tatsächlich)

1. April 1999

Studienabschluss (Tatsächlich)

1. April 1999

Studienanmeldedaten

Zuerst eingereicht

29. April 2008

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. April 2008

Zuerst gepostet (Schätzen)

1. Mai 2008

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

1. Mai 2008

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. April 2008

Zuletzt verifiziert

1. April 2008

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 547
  • B3D-MC-GHAC

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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