Intra-venous Zoledronic Acid Once Yearly

NCT00984893 | Completed

• 1 other identifier: CZOL446HCA10
• Study Type: observational
• Target: 1,551
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Post-Menopausal Osteoporosis

Keywords

Osteoporosis; Bone Mineral density; fragility fractures; zoledronic acid.; Treatment

Outcome Measures

Primary Outcomes (1)

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

  4 years

Secondary Outcomes (5)

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

  4 years

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

  4 years

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

  4 years

• Risk for fractures

  4 years

• Burden of illness, health care resource utilization, and loss of productivity

  4 years

Study Arms (2)

Zoledronic acid

Drug: zoledronic acid

Oral Bisphosphonates

Drug: Any oral bisphosphonates marketed in Canada

Interventions

zoledronic acid DRUG

Zoledronic acid

Any oral bisphosphonates marketed in Canada DRUG

Oral Bisphosphonates

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Groupe de recherche en rhumatologie et maladies osseuses Inc

Québec, Quebec, Canada

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marc Vaillancourt

  Novartis Pharmaceuticals Canada

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2009
• First Posted: September 25, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

CA (3)