| CTRI Number |
CTRI/2024/12/078104 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case-control study design with longitudinal component on cases |
| Study Design |
Other |
|
Public Title of Study
|
Bone mineral density, Bone turnover markers and fracture risk in hyperthyroidism and their change with antithyroid therapy. |
|
Scientific Title of Study
|
Effect of Hyperthyroidism on Bone Mineral density, Bone turnover markers and fracture risk before and after treatment
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHABANI SANKAR DHAL |
| Designation |
DM resident |
| Affiliation |
MKCG medical college |
| Address |
Dept. of Endocrinology,
MKCG medical college, Berhampur,
Odisha
760004
Ganjam
ORISSA
760004
India |
| Phone |
7894147349 |
| Fax |
|
| Email |
iambhabs11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Ravi Kumar |
| Designation |
Professor and Head |
| Affiliation |
MKCG Medical College |
| Address |
Dept. of Endocrinology,
MKCG medical college, Berhampur,
Odisha
760004
Ganjam
ORISSA
760004
India |
| Phone |
9438822781 |
| Fax |
|
| Email |
mkcgendocrinology@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHABANI SANKAR DHAL |
| Designation |
DM resident |
| Affiliation |
MKCG medical college |
| Address |
Dept. of Endocrinology,
MKCG medical college, Berhampur,
Odisha
760004
Ganjam
ORISSA
760004
India |
| Phone |
7894147349 |
| Fax |
|
| Email |
iambhabs11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Endocrinology, MKCG Medical college, Berhampur, Ganjam,Odisha, 760004 |
|
|
Primary Sponsor
|
| Name |
Bhabani Sankar Dhal |
| Address |
Room-503, SR Hostel, MKCG Medical college, Berhampur, Odisha, 760004 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhabani Sankar Dhal |
MKCG medical college |
Department of Endocrinology,
MKCG medical college,
Berhampur,
Odisha,
760004
Ganjam
ORISSA |
07894147349
iambhabs11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , M.K.C.G MEDICAL COLLEGE, BRAHMAPUR-760004, GANJAM.(ODISHA) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
not having any disease |
| Patients |
(1) ICD-10 Condition: E050||Thyrotoxicosis with diffuse goiter, (2) ICD-10 Condition: E052||Thyrotoxicosis with toxic multinodular goiter, (3) ICD-10 Condition: E051||Thyrotoxicosis with toxic single thyroid nodule, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
premenopausal females and males aged 18–65 years, with newly detected hyperthyroidism were included in this study. The patients with hyperthyroidism had a diagnosis of Graves disease, Toxic MNG or Toxic adenoma. There were also age, sex, BMI matched healthy control groups who were euthyroid. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
1.to comapre BMD, bone turnover markers, fracture risk of newly diagnosed hyperthyroid patients with
control
2. to compare the change in bone turnover markers after treatment with baseline
3. to compare the change in BMD, fracture risk after treatment with baseline
|
1.at baseline ,
2. after 3 months of euthyroid state
3. 1 year after treatment for BMD and fracture risk |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation of thyroid hormones with bone turnover markers at baseline |
at baseline before treatment |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
25/12/2024 |
| 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="0"
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
|
ØTo compare the BMD status in hyperthyroid patients with control group at baseline and to see the effect of antithyroid treatment on BMD at 1 year of therapy in hyperthyroid patients. ØTo compare the levels of Sr. P1NP ,CTX in Hyperthyroid patients with control group at baseline. ØTo see the effect of antithyroid treatment on levels of Sr. P1NP and CTX after achievement of normal thyroid status for 3 months in hyperthyroid patients. ØTo look for the fracture risk in hyperthyroid patients and to see the effect of antithyroid treatment on fracture risk at 1 year of therapy.
|