| CTRI Number |
CTRI/2009/091/000190 [Registered on: 27/04/2010] |
| Last Modified On: |
20/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the safety and efficacy of teriparatide in postmenopausal osteoporosis |
Scientific Title of Study
Modification(s)
|
A prospective, multi-centric, open-label, randomised, controlled study to evaluate the safety and efficacy of teriparatide (rhPTH 1-34) in postmenopausal osteoporosis. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| TPTD.09.001.01.01 ver 01 dated 9 Feb 2009 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Rajendra H Jani |
| Designation |
Senior Vice President Clinical R&D |
| Affiliation |
Cadila Helathcare Limited |
| Address |
Zydus Cadila House
Plot No 360 TPS 5 Service road Vile Parle East
Mumbai
MAHARASHTRA
400057
India |
| Phone |
00912226186057 |
| Fax |
00912226151735 |
| Email |
rhjani@zyduscadila.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Rajendra H Jani |
| Designation |
Senior Vice President, Clinical R&D |
| Affiliation |
Cadila Healthcare Limited |
| Address |
Zydus Cadila House TPS 5 Plot 360 Service Road Vile Parle East
Mumbai
MAHARASHTRA
400057
India |
| Phone |
00912226186057 |
| Fax |
00912226151735 |
| Email |
clinical@zyduscadila.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Rajendra H Jani |
| Designation |
Senior Vice President, Clinical R&D |
| Affiliation |
Cadial Healthcare Limited |
| Address |
Zydus Cadila House
Plot no 360 TPS 5 Service Road Vile Parle East
Mumbai
MAHARASHTRA
400057
India |
| Phone |
00912226186057 |
| Fax |
00912226151735 |
| Email |
rhjani@zyduscadila.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Cadila Healthcare Limited
Zydus Cadila House, Plot No. 360, TPS 5, Dayaldas Road - Service Road Crossing, Vile Parle (E), Mumbai-400057, India. |
|
Primary Sponsor
Modification(s)
|
| Name |
Cadila Healthcare Limited |
| Address |
Zydus Tower, Satellite Cross Road, Ahmedabad-380015, Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Girsh Autade |
Ashwini Accident and Multi Specialty Hospital |
Ashwini Accident and Multi Specialty Hospital, Govind nagar,Chowk No.5, Behind Hotel Prakash, Mumbai Naka -422001
Nashik
MAHARASHTRA |
09822060200, 02532599994
autudegj@gmail.com |
| Dr Dipak Dave |
HCG Medisurge Hospital |
HCG Medisurge Hospital,Near Mithakali Six Roads, Ellisbridge-380006
Ahmadabad
GUJARAT |
079 40010201
drdipakdave@yahoo.com |
| Dr Satinath Mukherjee |
Institute of Postgraduate Medical Education & Research (IPGMER) |
Department of Endocrinology & Metabolism, IPGMER,244, A. J. C. Bose Road-700060
Kolkata
WEST BENGAL |
033 24580101
satinath.mukhopadhyay@gmail.com |
| Dr Kurus Coyaji |
KEM Hospital |
KEM Hospital,Rasta Peth-411011
Pune
MAHARASHTRA |
020 26124586
kurus@vsnl.com |
| Dr Vikas Pai |
Oyster and Pearl Hospitals Pvt. Ltd |
Oyster and Pearl Hospitals Pvt. Ltd, Sr. No. 1671 to 1675,Plot No. 12, Shivaji Nagar-411005
Pune
MAHARASHTRA |
020-25534404, 25534944
paivikas@indiatimes.com |
| Dr Jagdip T Shah |
Parakh Hospital |
Parakh Hospital, Khokhani Lane,Opp. Ghatkopar Rly. Stn., Ghatkopar (E)-400077
Mumbai
MAHARASHTRA |
022 25157000/01/02/03
jagdip@parakhhospital.com |
| Dr Anil Bhansali |
Post-Graduate Institute of Medical Education & Research (PGIMER) |
Department of Endocrinology, PGIMER,Sector-12-160012
Chandigarh
CHANDIGARH |
0172 2756583, 0172 2756581
anilbhansali_endocrine@rediffmail.com |
| Dr Navneet Shah |
Sterling Hospital |
Sterling Hospital, Sterling Hospital Road,Memnagar-380052
Ahmadabad
GUJARAT |
09824030544
navneetnshah2000@gmail.com , navneetnshah2000@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| HCG Medisurge Ethics Committee |
Approved |
| Independent ethics Committee, Aditya |
Approved |
| Institutional Ethics Commitee IPGMER |
Approved |
| Institutional Ethics Committee KEMHRC |
Approved |
| Mahalasa Independent Ethics Committee |
Approved |
| Pioneer Ethics Committee |
Approved |
| Post Graduate Institute of Medical Education & Research (PGIMER) IEC |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture, Postmenopausal osteoporosis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium + Vitamin D3 |
Calcium 1000 mg + Vitamin D3 400mcg PO once daily |
| Intervention |
Teriparatide |
20 microgram OD Subcutaneous for 12 weeks |
| Comparator Agent |
Vitamin D |
400 microgm. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1.Postmenopausal women diagnosed as osteoporosis with T score between ranges of -2.5 to -4 at any one of the two sites measured (lumbar spine and femoral neck).
2. Subjects who are in the opinion of the investigator, likely to comply with the protocol and the investigator?s instructions during the study period.
3. Subjects giving informed consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity to teriparatide or any other PTH.
2. History of nephrolithiasis/ urolithiasis in the past 1 year.
3. Abnormal liver function test (ALT/AST>/= 2.5 times UNL) or kidney function test (serum creatinine >/= 2.0 mg/dl and calculated GFR value).
4. Abnormal or clinically significant laboratory values of parathyroid hormone (PTH), Serum Calcium (Ca), and Alkaline phosphatase (ALP).
5. History of hyperuricemia/gout.
6. History of malignancy/ radiotherapy.
7. History of diseases causing malabsorption in the last one year.
8. History of iatrogenic menopause.
9. History of secondary osteoporosis eg. Pagets disease, renal osteodystrophy, osteomalacia, hypoparathyroidism, hyperparathyroidism, hyperthyroidisim, drug induced (Appendix I) etc.
10. Subjects having history of any vertebral deformities at L1-L4 interfering with the measurement of BMD with Dual energy X-ray Absorptiometry (DEXA)
11. Subjects using bone modulating drugs (Appendix II), oral/ parenteral steroids and/or Hormone replacement therapy (HRT) in the last six months.
12. Subjects requiring other unacceptable concomitant medicines eg. Digitalis, Verapamil, diltiazem, diuretics etc.
13. Subjects with abnormal ECG findings.
14. Subjects participated in any clinical trial in the last six months. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Percentage change in biomarker of bone
formation, Procollagen type 1 N-terminal peptide (P1NP) from
baseline |
3 months. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Percentage change in:
1. Biomarker of bone formation, Bone specific alkaline phosphatase (BSAP) from baseline.
2. Bone Mineral density (BMD) at the end of 3 months over baseline, at lumbar spine (L1-L4). |
At the end of 3 months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="83"
Sample Size from India="83"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
26/08/2010 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, multi-centric, open-label, randomised, controlled study to evaluate the safety and efficacy of teriparatide (rhPTH1-34) in postmenopausal women with osteoporosis.
Primary Objective of this study is to assess the percentage change in biomarker of bone formation, Procollagen type 1 N-terminal peptide (P1NP) from baseline at 3 months in postmenopausal osteoporosis.
Secondary Objective(s) of this study are to assess the percentage change in biomarker of bone formation, Bone specific alkaline phosphatase (BSAP) from baseline at the end of 3 months and Bone Mineral density (BMD) at the end of 3 months over baseline, at lumbar spine (L1-L4). |