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OpenTrials
Completed

NCT Number: NCT00984893

Intra-venous Zoledronic Acid Once Yearly

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.

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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

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Zoledronic acid

Drug

Any oral bisphosphonates marketed in Canada

Drug

Primary outcomes

  1. Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)

    Time frame: 4 years

Secondary outcomes

  1. change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)

    Time frame: 4 years

  2. change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)

    Time frame: 4 years

  3. Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)

    Time frame: 4 years

  4. Risk for fractures

    Time frame: 4 years

  5. Burden of illness, health care resource utilization, and loss of productivity

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates

Acronym: IVORY

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Sep 25, 2009
Registry last updated
Mar 4, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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