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CTRI Number  CTRI/2022/02/039978 [Registered on: 03/02/2022] Trial Registered Prospectively
Last Modified On: 27/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Choice of anti-osteoporotic therapy in postmenopausal women with type 2 diabetes mellitus at high risk of low trauma fractures. 
Scientific Title of Study   Randomized controlled trial comparing the efficacy of teriparatide, zoledronate and denosumab in postmenopausal women with type 2 diabetes mellitus at high risk of fragility fractures: a pilot study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rimesh Pal 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Nehru Hospital Extension, Department of Endocrinology, PGIMER, Sector-12,

Chandigarh
CHANDIGARH
160012
India 
Phone  8727053344  
Fax    
Email  rimesh.ben@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rimesh Pal 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Nehru Hospital Extension, Department of Endocrinology, PGIMER, Sector-12,

Chandigarh
CHANDIGARH
160012
India 
Phone  8727053344  
Fax    
Email  rimesh.ben@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Trupti Nagendra Prasad 
Designation  Senior Resident 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Nehru Hospital Extension, Department of Endocrinology, PGIMER, Sector-12,

Chandigarh
CHANDIGARH
160012
India 
Phone  9309792795  
Fax    
Email  truptiprasad2303@gmail.com  
 
Source of Monetary or Material Support  
PGIMER Sector 12 Chandigarh 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research Chandigarh 
Address  Sector 12 Chandigarh-160012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rimesh Pal  Postgraduate Institute of Medical Education and Research  Department of Endocrinology Room Number: 007 Nehru Hospital Extension
Chandigarh
CHANDIGARH 		 8727053344

rimesh.ben@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Denosumab plus routine standard of care (Group C)  Injection denosumab 60 mg is to be administered subcutaneously every 6 months along with routine standard of care (calcium and vitamin D supplementation) for 18 months (3 doses) 
Comparator Agent  Routine standard of care for patients with osteoporosis (Group D)  Routine standard of care includes oral calcium supplementation (1000 mg/day) and oral vitamin D supplementation (1000 U/day of cholecalciferol) for 18 months 
Intervention  Teriparatide plus routine standard of care (Group A)  Injection Teriparatide 20 micrograms per day is to be administered subcutaneously along with routine standard of care (calcium and vitamin D supplementation) for 18 months  
Intervention  Zoledronate plus routine standard of care (Group B)  Injection Zoledronate 5 mg is to be administered intravenously once a year along with routine standard of care (calcium and vitamin D supplementation) for 18 months (2 doses) 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  1. Ambulatory type 2 diabetes mellitus postmenopausal females
2. Age more than or equal to 50 years
3. Postmenopausal status for at least 5 years
4. Duration of type 2 diabetes mellitus at least 5 years
5. Baseline eGFR more than or equal to 45 ml/min/1.73 m2
6. Baseline HbA1c 7-10%
7. Baseline BMI more than or equal to 23 kg/m2
8. Prior vertebral (clinical or morphometric), hip, radius, humerus fragility fracture OR
9. Baseline BMD T-score at lumbar spine or femoral neck less than or equal to -2.5 (corrected for T2D) and baseline FRAX score (corrected for T2D) indicating a 10-year probability of hip fracture more than or equal to 2.5% or of major osteoporotic fracture more than or equal to 9%.
10. Those willing to give informed consent
 
 
ExclusionCriteria 
Details  1. Type 1 diabetes mellitus or latent autoimmune diabetes in adults, or secondary diabetes mellitus
2. Prior history of use of bone-active therapies (bisphosphonates, teriparatide, denosumab, selective estrogen receptor modulators, hormone replacement therapies, calcitonin)
3. Prior history of glucocorticoid use at a dose more than or equal to 15 mg (prednisolone or equivalent) for more than or equal to 3 months.
4. History of use of pioglitazone, thiazides, or canagliflozin over last 6 months
5. Hyperthyroidism (overt/subclinical) or overt hypothyroidism (detected during baseline screening)
6. History of hypoparathyroidism or primary hyperparathyroidism
7. History of acromegaly
8. History of Addison disease or Cushing’s syndrome
9. History of gonadal insufficiency (primary or secondary)
10. History of hypercalcemia (or detected during baseline screening)
11. Elevated hepatic transaminase levels more than or equal to 3 times upper limit of normal (detected during baseline screening)
12. Any solid organ or bone marrow transplant
13. History of any active or past malignancy
14. History of gastrointestinal disorders and malabsorption states, namely, celiac disease (also screened at baseline), inflammatory bowel disease, chronic hepatitis, bowel resection, chronic liver disease, gastrectomy, lactose intolerance
15. History of bone marrow related disorders, namely, leukemia, lymphoma, hemochromatosis, multiple myeloma (also screened at baseline), sarcoidosis, sickle cell anemia, thalassemia, amyloidosis
16. History of rheumatological disorders, namely, rheumatoid arthritis, ankylosing spondylitis, Marfans syndrome, Ehler-Danlos syndrome
17. History of any condition that may affect bone metabolism, namely, Paget’s disease, osteopetrosis, osteogenesis imperfecta, hypophosphatasia
18. History of recent tooth extraction (within 6 months of screening)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the percent change in BMD at the lumbar spine and femoral neck at the end of intervention
2. To assess the frequency of incident clinical major osteoporotic fractures (fragility) and/or morphometric vertebral fractures (fragility) during intervention
 		 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the percent change in BMD at the 33% radius at the end of intervention
2. To assess the change in trabecular bone score (TBS) at the end of intervention
3. To assess the change in high-resolution peripheral quantitative computed tomography (HR-pQCT) parameters at the end of intervention
4. To assess the change in bone turnover markers (BTMs) during and at the end of intervention
5. To assess the short-term change in glycemic control with anti-osteoporotic treatment as estimated using 2-weeks flash glucose monitoring

 		 18 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   N/A 
Date of First Enrollment (India)   05/02/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 NIL  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 This study is a randomized, parallel group, multiple arm, single centered trial comparing the efficacy of teriparatide, zoledronate and denosumab, where every consecutive postmenopausal women diagnosed with type 2 DM attending  the endocrinology clinic at PGIMER, Chandigarh would be screened for possible inclusion in study. Those fulfilling the criteria would be randomized into 4 groups in 1:1:1:1 ratio. Group A (n=30) would receive injection teriparatide daily, Group B (n=30) would receive injection zoledronate 5mg once yearly, Group C (n=30) would receive injection denosumab 60mg every 6 months, along with calcium and vitamin D supplements. Group D (n=30) would receive only calcium and vitamin D supplements. The primary outcome would be to assess the percent change in BMD at lumbar spine and femoral neck and frequency of incident clinical major osteoporotic  and/or morphometric vertebral fragility fractures. Secondary outcomes will be to assess the change in BMD at distal radius, trabecular bone score, HR-pQCT (high-resolution peripheral quantitative computed tomography) parameters and bone turnover markers at the end of intervention and also to assess short-term change in glycemic control with anti-osteoporotic treatment.

Trial is open to recruitment and as of date, 27-08-2022, 88 participants have recruited with 22 participants in each group and we have been following them as mentioned in the protocol.
No serious adverse events noted so far.   
 
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