| CTRI Number |
CTRI/2011/091/000046 [Registered on: 28/02/2011] |
| Last Modified On: |
06/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Assessment of Zoledronic acid Utilizing Real-world Experience (AZURE) |
Scientific Title of Study
Modification(s)
|
An observational, prospective, open-label study to assess effectiveness, safety and tolerability of once-yearly treatment with zoledronic acid in osteoporotic patients in a real-world setting |
| Trial Acronym |
AZURE |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CZOL446H-MAX-IN-01 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr SM Lakhotia |
| Designation |
|
| Affiliation |
|
| Address |
Krishna Apartment
168/31/2A, Lake Garden
Kolkata
WEST BENGAL
700045
India |
| Phone |
09831002035 |
| Fax |
|
| Email |
smlakhotia@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ankur Malhotra |
| Designation |
|
| Affiliation |
Medical Advisor, Novartis |
| Address |
Novartis India Limited,Sandoz House, 5th floor, Shivsagar Estate,
Dr. Annie Besant Road, Worli, Mumbai -400018. India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958582 |
| Fax |
022-24954112 |
| Email |
ankur.malhotra@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ankur Malhotra |
| Designation |
|
| Affiliation |
|
| Address |
Novartis India Limited,Sandoz House, 5th floor, Shivsagar Estate,
Dr. Annie Besant Road, Worli, Mumbai -400018. India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958582 |
| Fax |
022-24954112 |
| Email |
ankur.malhotra@novartis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novartis Health Care Pvt Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
Sandoz house,
Shivsagar Estate,
Dr. A.B.Road, Worli,
Mumbai - 400018 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Shailendra Mohan Lakhotia |
|
Krishna Apartment, 168/31/2A, Lake Garden, ,Kolkata -700045, West Bengal.-700045
|
09831002035
smlakhotia@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM . Bangalore |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
OSTEOPOROSIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
|
| Intervention |
Zoledronic acid |
5mg IV Infusion , once a year |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Post menopausal osteoporosis: Female post menopausal osteoporotic patients who have been prescribed once yearly therapy with 5 mg i.v. zoledronic acid in adherence with the local prescribing information.
2. Glucocorticoid-induced osteoporosis :Male or female osteoporotic patients aged ≥18 years, receiving at least 5 mg/d oral prednisone (or equivalent systemic steroid) at study entry, and expected to receive glucocorticoids for at least another 12 to 24 months, who have been prescribed once yearly therapy with 5 mg i.v. zoledronic acid in adherence to the local prescribing information
3. Male Osteoporosis indication: Male patients aged ≥ 50 years, diagnosed with male osteoporosis, who have been prescribed once yearly therapy with 5 mg i.v. zoledronic acid in adherence with the local prescribing information
4. Patients for whom the treating physician recommends treatment with once yearly therapy with 5 mg i.v. zoledronic acid, and zoledronic acid has been prescribed in the course of routine medical practice and according to local Summary of Product Characteristics (SmPC) or Prescribing Information (PI)
5. Patients willing to answer short questionnaires (back pain and disability, patient satisfaction and patient preference for treatment questionnaires)
6. Patients willing to be followed for up to 24 months
7. Patients who consent to have their data collected. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care
|
|
| ExclusionCriteria |
| Details |
1. Any contraindication according to local SmPC or PI (Summary of Product Characteristics or Prescribing Information) of 5 mg i.v. zoledronic acid including pregnant and nursing women |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1. To assess treatment adherence to once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions over observational periods of 12 months and 24 months (based on consecutive yearly injections) |
At 12 months and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To study the evolution of bone mineral density over observational periods of 12 months and 24 months in patients receiving once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions.
2. To characterize the patient population (demographics, medical histories, osteoporosis risk factors, prior and co-medications etc.) receiving once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions
3. To evaluate the safety of once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice conditions over an observational period of 24 months
4. To evaluate the patient preference for treatment
5. To study other indicators of bone health (back pain, fragility fractures) over an observational periods of 12 months and 24 months in patients receiving once yearly therapy with 5 mg i.v. zoledronic acid under real-world clinical practice
|
At 12 months and 24 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="3400"
Sample Size from India="1700"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
29/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
publication will be planned by Global |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Osteoporosis is associated with significant morbidity and mortality, which place a heavy burden on society. The efficacy of current osteoporosis therapies is compromised by low rates of adherence and persistence. Poor adherence is associated with significant clinical consequences, most notably, increased fracture rates. Annual infusions of an osteoporosis drug may be one means of improving adherence and persistence. Indeed, a patient preference study of theoretical treatment choices found that 65% of treatment-naïve patients said they would prefer an annual bisphosphonate (BP) infusion to weekly pills. Limited patient numbers determined by stringent inclusion and exclusion criteria of RCTs preclude application of the findings to a larger population. Observational studies are needed to examine the effectiveness, safety and tolerability of the treatment in routine clinical practice, to determine how the treatment works under ordinary and variable conditions, prescribed by clinicians with varying degrees of expertise and practicing across the spectrum of health care settings, to treat a heterogeneous group of patients. The AZURE study (Assessment of Zoledronic acid Utilizing Real-world Experience) is an observational, prospective, open-label study to assess effectiveness, safety and tolerability of once-yearly treatment with zoledronic acid in osteoporotic patients in a real-world setting. |