| CTRI Number |
CTRI/2025/03/082364 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Zolendronate on bone health in subjects with hypopituitarism |
|
Scientific Title of Study
|
Effect of Zolendronate on bone health in subjects with hypopituitarism - an open labelled randomised clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Battu Sree Vaishnavi |
| Designation |
Academic Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Endocrinology, 1C3, AIIMS, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9177020152 |
| Fax |
|
| Email |
sreevaishnavi1523@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amritava Ghosh |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Endocrinology,1C3, AIIMS, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
07712577325 |
| Fax |
|
| Email |
endocrinologyandmetabolism@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Battu Sree Vaishnavi |
| Designation |
Academic Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Endocrinology, 1C3, AIIMS, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9177020152 |
| Fax |
|
| Email |
sreevaishnavi1523@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur, Chhattisgarh, pin code - 492099, India |
|
|
Primary Sponsor
|
| Name |
Battu Sree Vaishnavi |
| Address |
Department of Endocrinology, AIIMS, Raipur, Chhattisgarh, pin code - 492099, India |
| 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 |
| Battu Sree Vaishnavi |
All India Institute of Medical Sciences |
Department of Endocrinology, AIIMS, Tatibandh, Raipur
Raipur
CHHATTISGARH |
07712577325
sreevaishnavi1523@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee IEC-AIIMS,Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E230||Hypopituitarism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV Zolendronate |
IV Zolendronate infusion 5mg single dose along with standard care of treatment.
Participants will continue to receive standard treatment in the form of hormone replacement therapy for pituitary hormone deficiencies i.e hypothyroidism, hypogonadism, adrenal insufficiency (study will only recruit patients non complaint to GH treatment or in whom GH treatment is contraindicated) |
| Comparator Agent |
No active intervention |
Patients do not receive any active intervention. Participants will continue to receive standard treatment in the form of hormone replacement therapy for pituitary hormone deficiencies i.e hypothyroidism, hypogonadism, adrenal insufficiency (study will only recruit patients non complaint to GH treatment or in whom GH treatment is contraindicated) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than or equal to 18 years 2.Patients with hypopituitarism 3.Presence of GH deficiency 4.Patient non complaint to GH treatment or in whom GH treatment is contraindicated 5. Those who have given consent |
|
| ExclusionCriteria |
| Details |
1. Postmenopausal women 2. Pregnant women 3.Patients with known systemic disorders like chronic liver disease chronic kidney disease or bedridden status 4.Patients who underwent recent dental procedures in the past 3 months or planning for
dental procedures in the next 3 months
5.Patients who do not give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome - Bone mineral density at baseline and at the end of 1 year |
Primary outcome - Bone mineral density at baseline and at the end of 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Z Score at baseline & at the end of 1 year |
Z Score at baseline & at the end of 1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2025 |
| 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) |
Closed to Recruitment of Participants |
|
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
|
Pituitary hormones have direct and indirect effects on bone. Risk of fractures is 2 to 5 fold higher in adult Growth Hormone deficiency. In clinical practice, very limited patients with hypopituitarism are on Growth hormone replacement on account of residual tumour or inability to afford. Howeever, no study has evaluated the efficacy of bisphosphonates in prevention of bone loss among patients of hypopituitarism who are not on Growth Hormone therapy. This study aims to determine the effect of Zolendronic acid on bone health in subjects with hypopituitarism with Growth hormone deficiency. All adult patients with hypopituitarism presenting to Endocrinology and Metabolism OPD within the study period and satisfying inclusion and exclusion criteria will be included in the study, once they given the informed consent. All adult patients with hypopituitarism with Growth Hormone deficiency who are not complaint to GH treatment or in whom GH is contraindicated attending Endocrinology and Metabolism OPD at AIIMS, Raipur within the study period will be evaluated as per protocol. Detailed history will be obtained and detailed physical examination will be conducted. Results of available laboratory evaluations - biochemical parameters including calcium, albumin, ionized calcium, Creatinine, alkaline phosphatase, 25 hydroxy vitamin D, intact PTH. Randomization of participants will be done to 2 groups. Intervention group – Receiving Zolendronate, Control group – Not receiving Zolendronate. Allocation of participants will be done by block randomization. Randomisation will be done by online randomization tool. To one of the groups, the participants will be allocated to the intervention with Zolendronate with standard care of treatment and other group receives standardcare based on the sequence they enter the study. Bone mineral density at lumbar spine, proximal femur and distal forearm and body composition will be assessed (by Dual Energy X-rayAbsorptiometry) at the baseline, 6monthsand 1 year for all the patients. Data regarding the same will be collected and analysed statistically. |