Effect of Zolendronate on bone health in subjects with hypopituitarism - an open labelled randomised clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcome - Bone mineral density at baseline and at the end of 1 year
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary outcome - Bone mineral density at baseline and at the end of 1 year
时间窗: Primary outcome - Bone mineral density at baseline and at the end of 1 year
次要结局
- Z Score at baseline & at the end of 1 year(Z Score at baseline & at the end of 1 year)
研究者
Battu Sree Vaishnavi
All India Institute of Medical Sciences, Raipur