Intra-venous Zoledronic Acid Once Yearly

Overview

The study will assess the real life effectiveness of zoledronic acid in the management of patients with osteoporosis over 4 years of treatment. Zoledronic acid will be compared to oral bisphosphonates (OBP) with respect to the change in Bone Mineral Density (BMD) and incidence of fractures.

Full Title of Study: “A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2014

Interventions

  • Drug: zoledronic acid
  • Drug: Any oral bisphosphonates marketed in Canada

Arms, Groups and Cohorts

  • Zoledronic acid
  • Oral Bisphosphonates

Clinical Trial Outcome Measures

Primary Measures

  • Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)
    • Time Frame: 4 years

Secondary Measures

  • change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)
    • Time Frame: 4 years
  • change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
    • Time Frame: 4 years
  • Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
    • Time Frame: 4 years
  • Risk for fractures
    • Time Frame: 4 years
  • Burden of illness, health care resource utilization, and loss of productivity
    • Time Frame: 4 years

Participating in This Clinical Trial

Inclusion Criteria

  • Patient is an ambulatory female 45 years of age or older – Postmenopausal women with diagnosis of osteoporosis – Prescription of zoledronic acid or any OBP as per the current Canadian monograph – Must provide informed consent Exclusion Criteria:

  • Any prior use of iv bisphosphonates within the last 2 years – Known secondary osteoporosis of any aetiology (hypogonadism in premenopausal women or premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease) – Metabolic bone diseases such as primary or secondary hyperparathyroidism, hypoparathyroidism, Paget's disease of bone, Fibrous dysplasia.. – Non-corrected hypocalcaemia at the time of zoledronic acid infusion – Creatinine clearance < or = 30 ml/min – Unwillingness or inability to comply with the study requirements – Concurrent participation in a clinical trial of an investigational drug, or within the last 30 days Other protocol-defined inclusion/exclusion criteria may apply.

Gender Eligibility: Female

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Marc Vaillancourt, Study Director, Novartis Pharmaceuticals Canada

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