Management of Osteoporosis in Patients With Primary Hyperparathyroidism
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Bone mineral density after one year of treatment
研究概览
简要总结
Investigators will prospectively include 40 postmenopausal women with secondary osteoporosis due to primary hyperparathyroidism who have refused surgery. Participants will be randomized in two groups and treated either with zoledronic acid 5 mg iv once a year or with denosumab 60 mg sc every 6 months. Investigators will compare the effect of both drugs on bone turnover markers and basic laboratory parameters after 3, 12 and 24 months of treatment, and on the bone mineral density after 12 and 24 months of treatment. All participants will take cholecalciferol 800 - 1000 IU daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women (>12 months after last menstrual period) with primary hyperparathyroidism and with osteoporosis on Dual Energy Xray Absorptiometry (DXA) (according to International Society for Clinical Densitometry (ISCD) - criteria) and/or osteoporotic fracture of the vertebra or hip
排除标准
- •The patient is not able to give informed consent
- •other classic complications of primary hyperparathyroidism (e.g. kidney stones, renal insufficiency)
- •serum albumin-corrected calcium level > 2.85 mmol/L (except when the patient is reluctant to undergo surgical treatment)
- •osteoporosis treatment less than a year ago, less than two years ago in the case of oral bisphosphonate, less than three years ago in the case of parenteral bisphosphonate
- •bilateral hip endoprosthesis
- •additional causes for secondary osteoporosis (other than vitamin D deficiency) and pathological laboratory findings that are incompatible with the Summary of Product Characteristics (SmPC) of both medicines
- •cancer, except if in stable remission of more than 5 years
研究组 & 干预措施
denosumab
denosumab 60 mg subcutaneously every 6 months
干预措施: Denosumab 60 MG/ML Prefilled Syringe [Prolia] (Drug)
zoledronic acid
zoledronic acid 5 mg intravenously once a year
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
Bone mineral density after one year of treatment
时间窗: one year
Dual-energy X-ray absorptiometry (DXA)
PINP after 12 months of treatment
时间窗: one year
Unit of Measure: µg/L
PINP after 24 months of treatment
时间窗: two years
Unit of Measure: µg/L
CTX after 12 months of treatment
时间窗: one year
Unit of Measure: pmol/L
Bone-specific alkaline phosphatase (BAP) after 12 months of treatment
时间窗: one year
Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 24 months of treatment
时间窗: two years
Unit of Measure: µg/L
Corrected calcium after 3 months of treatment
时间窗: 3 months
Unit of Measure: mmol/L
PINP after 3 months of treatment
时间窗: 3 months
Unit of Measure: µg/L
Bone-specific alkaline phosphatase (BAP) after 3 months of treatment
时间窗: 3 months
Unit of Measure: µg/L
Corrected calcium after 24 months of treatment
时间窗: two years
Unit of Measure: mmol/L
CTX after 3 months of treatment
时间窗: 3 months
Unit of Measure: pmol/L
Bone mineral density after two years of treatment
时间窗: two years
Dual-energy X-ray absorptiometry (DXA)
CTX after 24 months of treatment
时间窗: two years
Unit of Measure: pmol/L
Corrected calcium after 12 months of treatment
时间窗: one year
Unit of Measure: mmol/L
次要结局
未报告次要终点
研究者
Tomaz Kocjan
Professor Tomaz Kocjan, MD, PhD
University Medical Centre Ljubljana