- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00303485
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
30 mars 2016 uppdaterad av: Hoffmann-La Roche
A Randomized, Double-blind, Placebo-controlled Study to Determine Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once Monthly Ibandronate in the Treatment of Postmenopausal Osteoporosis
This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated.
Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation.
The anticipated time on study treatment is approximately 7 months, and the target sample size is <100 individuals.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
67
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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Beverly Hills, California, Förenta staterna, 90211
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La Jolla, California, Förenta staterna, 92093
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Georgia
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Augusta, Georgia, Förenta staterna, 30904
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Minnesota
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Woodbury, Minnesota, Förenta staterna, 55125
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New York
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Bronx, New York, Förenta staterna, 10461
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Pennsylvania
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Hopwood, Pennsylvania, Förenta staterna, 15445
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53705
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Ponce, Puerto Rico, 00717-1318
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San Juan, Puerto Rico, 00935
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San Juan, Puerto Rico, 00927
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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
65 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;
- naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.
Exclusion Criteria:
- patients on hormone replacement therapy (HRT) within the last 3 months;
- patients on other osteoporosis medication within the last 3 months;
- sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;
- hypersensitivity to any component of ibandronate;
- contraindication for calcium or vitamin D therapy;
- history of major gastrointestinal upset;
- malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).
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 |
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Experimentell: Ibandronate
Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
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150 mg per månad i 6 månader
As prescribed
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Placebo-jämförare: Placebo
Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
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As prescribed
po monthly for 6 months
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3
Tidsram: Baseline (Visit 1) and Day 3
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Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body.
It is measured in units of nanograms (ng) per milliliter (mL).
The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) * 100.
The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening.
If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1) and Day 3
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
Tidsram: Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6
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sCTX is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body.
The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX Time point- sCTX Baseline) / (sCTX Baseline) * 100.
The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening.
If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6
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Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
Tidsram: Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6
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BSAP is a biochemical marker of bone formation and measured in units per litre (U/L).
The relative percent change in BSAP was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (BSAP time point- BSAP Baseline) / (BSAP Baseline) * 100.
The greater the percent decrease from Baseline, the greater the response to therapy.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6
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Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments
Tidsram: Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7
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Parathyroid hormone (PTH) regulates calcium and phosphate metabolism in bone and kidney, and is measured in picogram/milliliter (pg/mL).
The relative percent change in PTH was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (PTH time point- PTH Baseline) / (PTH Baseline) * 100.
Post treatment assessments were done at Baseline, Month (M)1 Day (D)7, and M6D7
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Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7
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Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
Tidsram: Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6
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The Cochran-Mantel Haenszel test stratified by Baseline sCTX category was used to compare the 2 treatment groups for proportion of participants whose sCTX concentration was between 0.011 and 0.631 ng/mL (premenopausal normal range mean +/- 2 SD) who achieved a decrease in sCTX of at least 8% from Baseline.
Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD=0.155 ng/mL.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6
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Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
Tidsram: Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
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Percentage of participants whose sCTX concentration was between 0.011 and 0.476 ng/mL (Mean -2 to + 1 SD) were analyzed at particular time points.
Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.
Baseline visit was defined as Visit 1.
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Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
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Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
Tidsram: Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
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Percentage of participants whose sCTX concentration was between 0.011 and 0.321 ng/mL (Mean -2 to + 0 SD) were analyzed at particular time points.
Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.
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Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
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Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations
Tidsram: Day (D)7, D14, D21 and D28 of Month 6
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Overall minimum and maximum relative percent change in sCTX concentrations from Baseline were calculated for all participants over D7, D14, D21 and D28 of Month 6 and the difference between it was analyzed.
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Day (D)7, D14, D21 and D28 of Month 6
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Number of Participants With Any Marked Abnormality in Laboratory Parameters
Tidsram: Up to 7 months
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Marked laboratory abnormalities are those which exceed the marked abnormality range (i.e., greater or less than the Roche defined marked abnormality range; i.e Low or High) and which also represents a clinically relevant change from Baseline of at least a designated amount.
The indicated abnormal laboratory parameters (along with their marked reference range) are as follows : Hematocrit (0.31- 0.56 fraction), hemoglobin (110 - 200 g/L), platelets (100 - 550 *10^9/L), white blood cell (WBC) (3.0 - 18.0 *10^9/L), alanine aminotransferase (ALT) (0 - 110 U/L), creatinine (0 - 154 µmol/L), chloride (95 - 115 mmol/L), phosphate (0.75 - 1.60 mmol/L ).
Creatinine clearance was calculated using the Cockroft-Gault formula.
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Up to 7 months
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Number of Participants With Any Adverse Event or Serious Adverse Event
Tidsram: Up to 7 months
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An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
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Up to 7 months
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Samarbetspartners och utredare
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Sponsor
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 februari 2006
Primärt slutförande (Faktisk)
1 juni 2007
Avslutad studie (Faktisk)
1 juni 2007
Studieregistreringsdatum
Först inskickad
16 mars 2006
Först inskickad som uppfyllde QC-kriterierna
16 mars 2006
Första postat (Uppskatta)
17 mars 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
2 maj 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
30 mars 2016
Senast verifierad
1 mars 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ML19334
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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