The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women
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:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 Primary Completion Date:||October 2017 (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|