Intra-venous Zoledronic Acid Once Yearly | NCT00984893

Studies
Intra-venous Zoledronic Acid Once Yearly

NCT00984893

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Mar 4, 2016Estimated

Enrollment

1,551Actual

Phase

Not provided

Conditions

Post-Menopausal Osteoporosis

Interventions

zoledronic acid
Any oral bisphosphonates marketed in Canada

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Sep 23, 2009

First Submission Date that Met QC Criteria

Sep 24, 2009

First Posted Date

Sep 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2016

Last Update Posted Date

Mar 4, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,551Actual

Label	Type	Description	Intervention Names
Zoledronic acid			Drug: zoledronic acid
Oral Bisphosphonates			Drug: Any oral bisphosphonates marketed in Canada

Name	Type	Description	Arm Group Labels	Other Names
zoledronic acid	Drug		Zoledronic acid
Any oral bisphosphonates marketed in Canada

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Marc Vaillancourt	Novartis Pharmaceuticals Canada	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D015663	Osteoporosis, Postmenopausal
D010024	Osteoporosis

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077211	Zoledronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Vancouver	British Columbia		Canada