Intra-venous Zoledronic Acid Once Yearly (IVORY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00984893
First received: September 23, 2009
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Post-Menopausal Osteoporosis
Drug: zoledronic acid
Drug: Any oral bisphosphonates marketed in Canada

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • change in hip BMD as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Risk for fractures [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Burden of illness, health care resource utilization, and loss of productivity [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: November 2008
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Zoledronic acid Drug: zoledronic acid
Oral Bisphosphonates Drug: Any oral bisphosphonates marketed in Canada

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ambulatory Female patients, at least 45 years of age, diagnosed with osteoporosis and taking either Zelodronic acid or any other oral bisphosphonates (OBP) as per the current Canadian monograph

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984893

Locations
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Hamilton, Ontario, Canada
Canada
Groupe de recherche en rhumatologie et maladies osseuses Inc
Quebec, Canada
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Marc Vaillancourt Novartis Pharmaceuticals Canada
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00984893     History of Changes
Other Study ID Numbers: CZOL446HCA10
Study First Received: September 23, 2009
Last Updated: March 17, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Novartis:
Osteoporosis
Bone Mineral density
fragility fractures
zoledronic acid.
Treatment

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014