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A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

5 december 2015 uppdaterad av: Hoffmann-La Roche

Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

160

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Colorado
      • Lakewood, Colorado, Förenta staterna, 80227
    • Florida
      • Stuart, Florida, Förenta staterna, 34996
    • Maryland
      • Bethesda, Maryland, Förenta staterna, 20817
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48236
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63110
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68131
    • New Mexico
      • Albuquerque, New Mexico, Förenta staterna, 87106
    • Ohio
      • Cincinnati, Ohio, Förenta staterna, 45224
    • Oregon
      • Portland, Oregon, Förenta staterna, 97213
    • Texas
      • Amarillo, Texas, Förenta staterna, 79124
    • Virginia
      • Norfolk, Virginia, Förenta staterna, 23502
      • Richmond, Virginia, Förenta staterna, 23294

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

45 år till 60 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • women 45-60 years of age;
  • post-menopausal;
  • ambulatory.

Exclusion Criteria:

  • vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
  • low-trauma osteoporotic fracture in any other bone;
  • breast cancer diagnosed within last 20 years;
  • other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
  • treatment with any bisphosphonate within last 2 years;
  • treatment with other drugs affecting bone metabolism within last 6 months.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 1
Läkemedel: ibandronate [Bonviva/Boniva]
150mg po monthly for 1 year
Placebo-jämförare: 2
Läkemedel: Placebo
po monthly for 1 year

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Relative Change From Baseline in Mean Bone Mineral Density (BMD) of the Lumbar Spine (L2 to L4) at Month 12
Tidsram: Baseline and Month 12
BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at baseline) / (BMD at baseline)
Baseline and Month 12

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute Change From Baseline in Mean Lumbar Spine BMD at Month 12
Tidsram: Baseline and Month 12
BMD was measured by a single dual-energy x-ray absorptiometry (DEXA) scan of the lumbar spine at the time of screening and at Month 12. A BMD measurement was considered unsuitable in case of detection of a fracture, an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was measured as g/cm^2 and summarized using descriptive statistics.
Baseline and Month 12
Relative Change From Baseline in Mean Proximal Femur BMD at Month 12
Tidsram: Baseline and Month 12
BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The relative (%) change from Baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.
Baseline and Month 12
Absolute Change From Baseline in BMD of the Proximal Femur at Month 12
Tidsram: Baseline and Month 12
BMD was measured by a single DEXA scan of the proximal femur at the time of screening and at Month 12. The absolute change from baseline in BMD of the proximal femur (total hip, trochanter, femoral neck) at Month 12 was summarized using descriptive statistics. BMD of fractured bones that could impact the scan area were not taken into account.
Baseline and Month 12
Relative Change From Baseline in Serum C-telopeptide Crosslinks of Type 1 Collagen (CTX)
Tidsram: Baseline and 3, 6 and 12 months
Fasting blood samples were collected from participants for analysis of serum CTX (sCTX), which is a biochemical marker of bone resorption. Relative change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.
Baseline and 3, 6 and 12 months
Absolute Change From Baseline in sCTX
Tidsram: Baseline and 3, 6, 12 months
Fasting blood samples were collected from participants for analysis of sCTX, which is a biochemical marker of bone resorption. Absolute change from baseline of sCTX after 3, 6, and 12 months of treatment was summarized using descriptive statistics.
Baseline and 3, 6, 12 months
Percentage of Responders
Tidsram: Up to 12 months
Percent responders were defined as follows: Participants with a) lumbar spine (LS) BMD, equal to or above Baseline at Month 12 b) proximal femur BMD, equal to or above Baseline at Month 12 c) Both lumbar spine and proximal femur BMD, equal or above Baseline at Month 12. BMD of the lumbar spine was defined as the BMD of at least two vertebrae (L2-L4) that were not fractured and not affected by an osteoarthritic process, or a scanning artifact that could not be removed to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center. Proximal femur included total hip, trochanter and femoral neck sites.
Up to 12 months
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: Up to 15 days after end of study treatment (Approximately 2 years)
An AE is any untoward medical occurrence in a participant who is administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Up to 15 days after end of study treatment (Approximately 2 years)
Number of Participants With Marked Laboratory Abnormalities
Tidsram: Screening up to 12 months
Blood for laboratory tests was taken at screening and immediately before participants received their monthly study medication at months 3, 6, and 12. The laboratory tests included: Hematology [white blood cells (WBCs), platelets, hematocrit, and hemoglobin] and Chemistry [albumin, creatinine, blood urea nitrogen (BUN), alanine aminotransferase (ALT), total calcium, 25-hydroxy vitamin D, phosphate, magnesium, sodium, potassium, and chloride].
Screening up to 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hoffmann-La Roche

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2005

Primärt slutförande (Faktisk)

1 december 2007

Avslutad studie (Faktisk)

1 december 2007

Studieregistreringsdatum

Först inskickad

11 augusti 2005

Först inskickad som uppfyllde QC-kriterierna

11 augusti 2005

Första postat (Uppskatta)

12 augusti 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

11 januari 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 december 2015

Senast verifierad

1 december 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • BA18492

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