The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women (Vitamin D)
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|ClinicalTrials.gov Identifier: NCT01694355|
Recruitment Status : Recruiting
First Posted : September 27, 2012
Last Update Posted : April 20, 2016
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.
|Condition or disease||Intervention/treatment|
|Vitamin D Deficiency||Drug: Vitamin D|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Vitamin D treatment
We assume that among postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD.
|Drug: Vitamin D|
- Change in BMD (Z score) following 10 months of vitamin D supplementation [ Time Frame: 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
- 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. [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694355
|Soroka University Medical Center||Recruiting|
|Be'er Sheva, Israel|
|Contact: Rita Troitsa firstname.lastname@example.org|
|Principal Investigator: Merav Fraenkel, MD|