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3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00718861
First received: July 18, 2008
Last updated: October 2, 2014
Last verified: September 2014

July 18, 2008
October 2, 2014
May 2008
April 2013   (final data collection date for primary outcome measure)
Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9 [ Time Frame: Year 6 (baseline) and Year 9 ] [ Designated as safety issue: No ]
Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
The percentage change in total hip BMD at Year 6 (baseline) and Year 9
Complete list of historical versions of study NCT00718861 on ClinicalTrials.gov Archive Site
  • Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6 [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8 ] [ Designated as safety issue: No ]
    Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
  • Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6 [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 6 = 100*(Year 9 - Year 6)/Year 6.
  • Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0 [ Time Frame: Year 0 (core baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 - Year 0)/Year 0.
  • Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0 [ Time Frame: Year 0 (core baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    Bone Mineral Density (BMD) measured by dual energy x-ray absorptiometry (DXA). DXA consists of two X-ray beams with different energy levels that are aimed at the patient's bones. When soft tissue absorption is subtracted out, the BMD can be determined from the absorption of each beam by bone. Percentage change from Year 0 = 100*(Year 9 - Year 0)/Year 0.
  • Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    Bone marker analysis: All patients had blood samples collected for analysis of serum c-terminal telopeptide of type I collagen (CTx). Serum CTX assays measure a fragment of the C-terminal telopeptide of type 1 collagen released during resorption of mature bone
  • Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    Bone marker analysis: All patients had blood samples collected for analysis of serum n-terminal propeptide of type I collagen (P1NP) The P1NP concentration is directly proportional to the amount of new collagen laid down during bone formation.
  • Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9 [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    Bone marker analysis: All patients had blood samples collected for analysis of serum bone-specific alkaline phosphatase (BSAP).Bone-specific alkaline phosphatase (BSAP) is a useful marker of active bone formation.
  • Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6 [ Time Frame: Year 6 (extension 2 baseline), Year 9 (3 years of study duration) ] [ Designated as safety issue: No ]
    Morphometric vertebral fracture (VF) was assessed based on morphometry. QM (quantitative morphometry) incident VF(QM positive) was defined by at least a 20% decrease in any vertebral height (at least 4 mm). If a participant had a QM positive at any vertebrae at any visit, x-rays from all visits for participants were evaluated using Genant semi-quantitative (SQ) method for VF assessment. A fracture was defined as an SQ reading that was greater than the baseline SQ reading.
  • Mean of Time to First Clinical Fracture [ Time Frame: over 3 years of study duration ] [ Designated as safety issue: No ]
    The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.
  • Change in Height at Years 7, 8 and 9 Relative to Year 6 [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ] [ Designated as safety issue: No ]
    Height was measured using a stadiometer in millimeters (mm). A stadiometer is a piece of medical equipment used for measuring height. It is usually constructed out of a ruler and a sliding horizontal headpiece which is adjusted to rest on the top of the head.
  • Differences between treatment groups in the percentage change of total hip and femoral neck BMD (bone mineral density) at year 7, 8 and 9 compared to year 0
  • Differences between treatment groups in the percentage change of total hip BMD at year 7 and 8 compared to year 6
  • Relative change in biomarkers
  • Relative change in height
  • Differences between treatment groups in the number of clinical fractures
Not Provided
Not Provided
 
3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs
A 3-year, Multicenter, Double-blind, Randomized, Placebo-controlled Extension to CZOL446H2301E1 to Evaluate the Efficacy and Long Term Safety of 6 and 9 Years Zoledronic Acid Treatment of Postmenopausal Women With Osteoporosis

This second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post-menopausal Osteoporosis
  • Drug: Placebo
  • Drug: Zoledronic acid
    Other Name: Reclast®, Aclasta®
  • Placebo Comparator: Placebo
    Matching placebo administered intravenously.
    Intervention: Drug: Placebo
  • Experimental: Zoledronic acid
    Intervention: Drug: Zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women who have received the 4th and 6th dose of zoledronic acid in study CZOL446H2301E1

Exclusion Criteria:

  • Poor kidney, eye, liver health
  • Use of certain therapies for osteoporosis in study CZOL446H2301E1
  • Abnormal calcium levels

Other protocol-defined inclusion/exclusion criteria may apply

Female
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Canada,   Colombia,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Italy,   New Zealand,   Norway,   Poland,   Sweden,   Switzerland,   Thailand
 
NCT00718861
CZOL446H2301E2, 2007-005383-27
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP