The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women (Vitamin D)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Be'er Sheva、以色列
- Soroka University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Signed Informed Consent.
- Female age 55-70
- At least 2 years past menopause
- 25(OH)D≤ 17.5nmol/L (≤7 ng/ml)
Exclusion Criteria:
1. Vitamin D levels > 30nmol/L in the past 2 years 2. Creatinine > 1.2%mg 3. Calcium ≥ 10.2mg/dl 4. Current or previous vitamin D treatment over 2 weeks 5. Previous vitamin D treatment over 2 months in the past 2 years 6. BMI>35 or BMI<20 7. Menopause before age 45 8. Type 1 diabetes 9. 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 10. 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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Vitamin D treatment
We assume that among postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in BMD (Z score) following 10 months of vitamin D supplementation
大体时间：10-14 months
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Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment
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10-14 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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.
大体时间：10-14 months
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Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment
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10-14 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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