Effect of Zolendronate on bone health in subjects with hypopituitarism - an open labelled randomised clinical trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Primary outcome - Bone mineral density at baseline and at the end of 1 year
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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
- •Those who have given consent.
Exclusion Criteria
- •Postmenopausal women
- •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.
Outcomes
Primary Outcomes
Primary outcome - Bone mineral density at baseline and at the end of 1 year
Time Frame: Primary outcome - Bone mineral density at baseline and at the end of 1 year
Secondary Outcomes
- Z Score at baseline & at the end of 1 year(Z Score at baseline & at the end of 1 year)
Investigators
Battu Sree Vaishnavi
All India Institute of Medical Sciences, Raipur