The Impact of Severe Vitamin D Deficiency and Its Correction on Bone Mineral Density (BMD) in Postmenopausal Women

Study Overview
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Brief Summary
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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.

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D treatment<br>We assume that among postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD. | Drug: Vitamin D<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMD (Z score) following 10 months of vitamin D supplementation | Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment | 10-14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Will be measured at 3 time points (repeated measures):at baseline visit, after 3-4 months and after 10 months of treatment | 10-14 months |