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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Change in BMD (Z score) following 10 months of vitamin D supplementation [ Time Frame: 10-14 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2019|
|Estimated Primary Completion Date:||October 2019 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694355
|Soroka University Medical Center||Recruiting|
|Be'er Sheva, Israel|
|Contact: Rita Troitsa firstname.lastname@example.org|
|Principal Investigator: Merav Fraenkel, MD|