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Completed

NCT Number: NCT00718861

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

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

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Key information

Conditions

Post-Menopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Zoledronic acid

Drug

Other names: Reclast®, Aclasta®

Primary outcomes

  1. Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9

    Time frame: Year 6 (baseline) and Year 9

    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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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

  6. 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

    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.

  7. 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

    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.

  8. 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)

    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.

  9. Mean of Time to First Clinical Fracture

    Time frame: over 3 years of study duration

    The mean of time to the first clinical fracture is estimated from the area under the Kaplan-Meier curve.

  10. 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

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 21, 2008
Registry last updated
Oct 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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