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CTRI Number  CTRI/2024/08/072044 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Bone health in women with premature menopause 
Scientific Title of Study   Multiparametric evaluation of bone health in women with premature ovarian insufficiency: A prospective cross-sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vidushi Kulshrestha 
Designation  Additional Professor 
Affiliation  AIIMS New Delhi 
Address  Room No 725 7th Floor Department of Obstetrics and Gynaecology Mother and Child Block AIIMS New Delhi

South
DELHI
110029
India 
Phone  9891910880  
Fax    
Email  drvidushi.kul@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pragya Shukla 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Room No 725 7th Floor Department of Obstetrics and Gynaecology Mother and Child Block AIIMS New Delhi

South
DELHI
110029
India 
Phone  8840614578  
Fax    
Email  pragyashukla07071998@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pragya Shukla 
Designation  Junior Resident 
Affiliation  AIIMS New Delhi 
Address  Room No 725 7th Floor Department of Obstetrics and Gynaecology Mother and Child Block AIIMS New Delhi

South
DELHI
110029
India 
Phone  8840614578  
Fax    
Email  pragyashukla07071998@gmail.com  
 
Source of Monetary or Material Support  
Research Section, AIIMS, New Delhi-110029 Intramural grant for financial support for Thesis grant wide letter with Reference No. F.No. 1-2/JR-SR-Thesis/2023/RS dated 22.02.2024 
 
Primary Sponsor  
Name  Research Section Thesis Grant AIIMS New Delhi 
Address  Research Section , AIIMS East Ansari Nagar New Delhi, PIN-110029 
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 Pragya Shukla  AIIMS New Delhi  Room No 725, Department of Obstetrics and Gynaecology, Mother and Child block, AIIMS, New Delhi
South
DELHI 		 8840614578

pragyashukla07071998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N912||Amenorrhea, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  None  None 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Subjects
Women with POI meeting all the following criteria
- Age less than 40 years
- Secondary amenorrhea for at least four months
- Elevated FSH 25.0 IU/L on two occasions at least 4 weeks apart
Controls
- Age and parity matched healthy women with normal menstrual cycles and serum FSH in normal range 
 
ExclusionCriteria 
Details  Both subjects and controls
- History of surgery on tubes/ovaries, post radiation, post chemotherapy
- Any systemic illness, History of chronic renal disease
- Hyperthyroidism, hyperparathyroidism
- On corticosteroids and anticonvulsant therapy which are known to affect bone metabolism
- Unwilling to give written informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
BMD at the spine and hip, TBS, serum levels of Osteopontin, P1NP, Beta Cross Laps  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
- Number of women with POI who have bone density scores less than one standard deviation below the mean of the reference group in spine and/or hip region
- Correlation of biomarkers levels with BMD & TBS
- Questionnaire to assess awareness of POI & its impact on bone. 		 At baseline 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/08/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Primary ovarian insufficiency (POI) is the cessation of ovarian function before the expected age of menopause and is defined by oligo/amenorrhea for at least 4   months, and an elevated FSH level more than 25 IU/l on two occasions at least 4 weeks apart in women under the age of 40 years. POI has long term consequences. It  affects bone health and leads to osteoporosis. Hence early detection is important to initiate treatment before POI affects the bone health.

Primary objective of this study is to evaluate bone health in women with POI as assessed by  multiple parameters of bone health including bone mineral density (BMD), Trabecular bone score (TBS)  and serum biomarkers. 

Secondary objective of this study is to compare BMD, TBS and serum levels of P1NP, Osteopontin, Beta Cross Laps in women with POI with controls and to assess awareness of women for impact of POI on their bone health.

 
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