| CTRI Number |
CTRI/2010/091/000637 [Registered on: 16/06/2010] |
| Last Modified On: |
13/03/2013 |
| 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)
|
An open label study to evaluate the safety and efficacy of Aclasta (Zoledronic acid) in treatment of patients with Glucocorticoid induced Osteoporosis |
Scientific Title of Study
Modification(s)
|
An open label study to evaluate the safety and efficacy of Aclasta (Zoledronic acid) in treatment of patients with Glucocorticoid induced Osteoporosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CZOL446OIN01 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Atul Kakar |
| Designation |
|
| Affiliation |
|
| Address |
31,South Patel Nagar
New Delhi
DELHI
110008
India |
| Phone |
09811110802 |
| Fax |
|
| Email |
atulkakar@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ankur Malhotra |
| Designation |
Medical Advisor |
| Affiliation |
Novartis |
| Address |
Sandoz House, 5th floor,Shivsagar Estate
Dr. Annie Besant Road,Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958582 |
| Fax |
24954112 |
| Email |
ankur.malhotra@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Ankur Malhotra |
| Designation |
|
| Affiliation |
Novartis |
| Address |
Sandoz House, 5th floor,Shivsagar Estate
Dr. Annie Besant Road,Worli
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-24958589 |
| Fax |
24954112 |
| Email |
ankur.malhotra@novartis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novartis Healthcare Private Limited
Sandoz House, 5th floor
Shivsagar Estate,
Dr. Annie Besant Road
Worli, Mumbai -400018. India |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Pvt Limited |
| Address |
Sandoz House, 5th floor, Shivsagar Estate,
Dr. Annie Besant Rd,
Worli,
Mumbai-18. |
| 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. Atul Kakar |
Dr. Atul kakar's Clinic |
31,South Patel Nagar,New Delhi-08-110008
New Delhi
DELHI |
09811110802
atulkakar@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Glucocorticoid induced Osteoporosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aclasta (Zoledronic acid ) |
5mg IV Infusion , once a year |
| Comparator Agent |
Nil |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Male & female patients aged 18?85 years taking atleast 5 mg/d oral prednisone (or equivalent systemic steroid) for at least 3 months prior to screening.
T score for bone mineral density at the lumbar spine or total hip of either?1.5 or less with or without fragility fractures
New patients or patients who were on other bisphosphonates earlier
Aclasta is medically recommended.
Willing to participate for 12 months.
Patient willing to provide written informed consent to participate in the study, as per local / institutional practice.
|
|
| ExclusionCriteria |
| Details |
 Hypersensitivity to zoledronic acid, to any of the excipients or to any bisphosphonate
 Females taking more than 30 micrograms/day of estradiol or equivalent in past 3 months
 Pregnant women or nursing mothers or women of childbearing potential not using adequate contraception
 Hypocalcemia
 Renal impairment (calculated creatinine clearance of less than 35 mL/min)
|
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To assess safety & tolerability of Aclasta in treatment of patients with Glucocorticoid induced osteoporosis |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
|  To assess the change in bone mineral density at month 12 after infusion of Zoledronic acid in treatment of patients with Glucocorticoid induced osteoporosis
 To assess the change in levels of bone turnover markers (C-telopeptide) at 6 and 12 months.
|
6 months and 12 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/05/2010 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Study Completed. Publication not done. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a 1-year, multicenter, open-label, prospective, observational, non-comparative post-marketing trial to collect the safety and efficacy data in Indian patients with glucocorticoid induced osteoporosis. Study will include patients on long term steroid treatment who have developed glucocorticoid induced osteoporosis. This study will not interfere with any therapeutic or diagnostic measures taken by the treating physicians. The patients will be recruited regardless of past or present therapeutic regimens (excluding current investigational agent). No patient randomization will be conducted as there is no comparator drug in this study. All eligible patients will receive a single 15-minute intravenous infusion of Aclasta (Zoledronic Acid) 5 mg, at baseline. In addition, those patients who have inadequate dietary intake of calcium or vitamin D will receive daily calcium and vitamin D supplementation, as per the discretion of physician. All Patients will be followed until 12 months. Primary end points in this study include safety outcome (AEs and SAEs) and incidence of graded laboratory abnormality. Secondary endpoints in this study include bone mineral density and bone turnover markers (C-telopeptide ) |