FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2010/091/000242 [Registered on: 13/04/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial with Teriparatide: a recombinant human parathyroid hormone) and Calcium and Vitamin D Supplementation in Post-menopausal Women with Osteoporosis. 
Scientific Title of Study   Evaluation of Safety and Efficacy of Teriparatide in Addition to Calcium And Vitamin D Supplementation in Comparison to Calcium and Vitamin D Supplementation Alone, in Increasing The Bone Mineral Density in Post-menopausal Women with Osteoporosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Teri /USV/001  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 

Not Applicable
N/A

India 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Vasant V Joshi 
Designation   
Affiliation   
Address  USV Ltd, BSD Marg, Govandi, Mumbai-400088.

Mumbai
MAHARASHTRA
400088
India 
Phone  +91-22-25564048  
Fax  +91-22-25584025  
Email  vasant.joshi@usv.co.in  
 
Details of Contact Person
Public Query  
Name  Mr. Pawan Bhusari  
Designation   
Affiliation   
Address  Sristek, DLF Cyber City, Block 3, 8th Floor, Gachibowli, Hyderabad-500032.

Hyderabad
ANDHRA PRADESH
500032
India 
Phone  +91-40-66129537  
Fax  +91-40-66129566  
Email  pawanbhusari@sristek.com  
 
Source of Monetary or Material Support  
USV Ltd B S D Marg, Govandi, Mumbai 400 088 Phone: (022) 2556 4048; Fax : (022) 2558 4025 
 
Primary Sponsor  
Name  USV Ltd B S D Marg, Govandi, Mumbai 400 088 Phone: (022) 2556 4048; Fax : (022) 2558 4025 
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Usha Sriram  Associates in Clinical Endocrinology Education and Research (ACEER), 7/12, 15th Cross street, Sastri Nagar, Adyar, Chennai ? 600020  ,-600020
Chennai
TAMIL NADU 		 044- 24460762/63
044-24460760/61
drushasriram@gmail.com 
Dr. Sanjay Kalra  Department of Endocrinology, Bharti Research Institute of Diabetes and Endocrinology , Bharti Hospital, Wagir Chand Colony, Kunj Pura Road Model Town, Near - Civil Line, Karnal Haryana  ,-
Karnal
HARYANA 		 0184-2268484
+91 184 4046554
brideknl@gmail.com 
Dr. Manash Pratim Baruah  Excel Centre, Maya Ville, Barthakur Mill Road, Ulubari, Guwahati ? 781007, Assam  ,-781007

 		 +91-361-2463099
+91-361-2464100
manashbaruahinin@yahoo.co.in 
Dr. Mohan Magdum  Jehangir Clinical Development Center Pvt Ltd, 32 Sassoon Road, Pune- 411005  ,-411005

 		 +91-20-25884491

mohanmagdum@gmail.com 
Dr. Satyanarayana Srikanta   Jnana Sanjeevini Medical Center  2,1 A cross; Marenahalli,,J. P Nagar II Phase-
Bangalore
KARNATAKA 

 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Hirabai Cowasji Jehangir medical research Institute and Jehangir Clinical Development Center Pvt Ltd  Approved 
Human research and ethics committee, Guwahati  Approved 
Institutional Ethics Committee, BRIDE, Karnal  Approved 
Madras Ethical Committee, Chennai  Approved 
SCIENCE FOR HEALTH, Bangalore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Osteoporosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral calcium supplementation of 1000 mg of elemental calcium and Vitamin D 500 IU per day  Elemental calcium 1000 mg and Vitamin D 500 IU/day, oral, in two divided doses for 12 months 
Intervention  Teriparatide [recombinant human parathyroid hormone (rPTH[1-34]) analogue]  20 Microgram injection by sc route, once daily for 12 months. 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1. Women with at least 3 years of post menopause, aged between 48 and 75 years. 2. Osteoporosis indicated by lumbar spine or femoral neck or total hip T score ≤ -2.5 on Dual energy X-ray absorptiometry (DEXA). 3. Normal thyroid and parathyroid function as indicated by baseline T3, T4 and TSH.4. Willingness to provide an informed and written consent. 
 
ExclusionCriteria 
Details  1. Women with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DEXA. 2. Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D < 20 ng/ml. 3. Patients with serum PTH > 65 pg/ml. 4. Patients with known hypersensitivity to Teriparatide, Vitamin D or Calcium supplements. 5. Patients with hypercalciuria or hypercalcemia. 6. Patients with hyperuremia or known history of gout and other diseases releated to uric acid accumulation. 7. Patients with a history of active or treated tuberculosis. 8. Patients with a history of significant liver disease, kidney disease, gastrointestinal disease or cancer. 9. Patients receiving concomitant medications such as oestrogen or oestrogen related compounds, bisphosphonates, fluorides or calcitonin within the previous 6 months that might have influenced bone mineralization. 10. Patients with clinically significant unstable medical disorders, life threatening disease, or current malignancies. 11. Patients with a BMI of < 18.5 kg/m2. 12 Patients on any of the following medications: Systemic or inhaled corticosteroids, Anticoagulants, Anticonvulsants. 13. Patients who are unwilling or unable to comply with the requirements of the protocol. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
At the end of study drug treatment (360 days from start of treatment) in Groups I and II: Increase in Bone Mineral density (BMD) from baseline at Lumbar spine L 1 to L 4.   At the end of study drug treatment (360 days from start of treatment) 
 
Secondary Outcome  
Outcome  TimePoints 
At the end of study drug treatment (360 days from start of treatment) in Groups I and II : Change in Bone Mineral density (BMD) from baseline at femoral neck and total hip regions. Change from baseline in biomarkers of bone formation and bone resorption. Occurrence of adverse events.   At the end of study drug treatment (360 days from start of treatment) 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/05/2010 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)   
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This proposed study is a randomized, open label, prospective, controlled, multicentric, between group comparison trial, eligible and consenting post-menopausal patients will be enrolled and randomized into two groups - Group I or Group II. Group I and Group II, will receive oral calcium supplementation of 1000 mg of elemental calcium and Vitamin D 500 IU per day, in two divided doses. In addition, Group I will receive Teriparatide sc injection 20 µg per day. All the patients will be assessed for primary endpoint, viz., increase in bone mineral density at Lumbar spine L 1 to L 4 from baseline, and secondary endpoints such as increase in bone mineral density at femoral neck and total hip regions, change from baseline in biomarkers of bone formation and bone resorption and occurrence of adverse events. This study will be conducted in approximately 5 -6 centers in India to recruit approximately 80 patients. 
Close