The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in BMD (Z score) following 10 months of vitamin D supplementation
研究概览
简要总结
It is well known that postmenopausal women are at risk for osteoporosis. The study hypothesis is that vitamin D deficiency (≤17.5nmol/L) is frequently associated with osteomalacia and will cause low BMD estimation in DXA scan due to insufficient bone mineralization.
We assume that among these postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD. According to the results, bisphosphonates therapy may be an unnecessary treatment.
The objective of this study is to evaluate the impact of severe vitamin D deficiency and its correction on Bone Mineral Density (BMD) in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent.
- •Female age 55-70
- •At least 2 years past menopause
- •25(OH)D≤ 17.5nmol/L (≤7 ng/ml)
排除标准
- •Vitamin D levels > 30nmol/L in the past 2 years
- •Creatinine > 1.2%mg
- •Calcium ≥ 10.2mg/dl
- •Current or previous vitamin D treatment over 2 weeks
- •Previous vitamin D treatment over 2 months in the past 2 years
- •BMI>35 or BMI<20
- •Menopause before age 45
- •Type 1 diabetes
- •Concomitant disease:
- •Mal-absorptive diseases (Cystic Fibrosis, Crohn's, gastric bypass surgery, celiac disease)
- •Rheumatoid arthritis
- •Nephrotic syndrome
- •Chronic renal failure
- •Primary hyperparathyroidism
- •Hyperthyroidism
- •Malignancies excluding skin cancers (within the last 5 years)
- •Kidney stones or history of renal colic
- •Medications:
- •Steroids use (past or present)
- •Anti rejection drugs in the last 5 years
- •Anticonvulsant (carbamezapine, hydantoin, Phenobarbital etc) in the last 5 years
- •Any anti osteoporotic medication: Prolia, Bisphosphonates, Teriperatide, Evista, Protelos, (past or present)
- •Post menopausal HRT (in the last 10 years)
- •Aromatase inhibitors: Femara, Arimadex (past or present)
- •Current use of PPIs (lanton, controloc, zoton, omepradex etc)
- •Current or past use of anti depressant SSRI (favoxil,cipralex etc)
研究组 & 干预措施
Vitamin D treatment
We assume that among postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Change in BMD (Z score) following 10 months of vitamin D supplementation
时间窗: 10-14 months
Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment
次要结局
- To examine the effect of increasing vitamin D levels on other objective parameters such as PTH, calcium, phosphorus and other subjective parameters such as muscle weakness, according to comparison between baseline visit and end of study visit.(10-14 months)
研究者
Merav Fraenkel
Senior Endocrinologist
Soroka University Medical Center