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

Vitamin D Deficiency Clinical Trial

— Vitamin D  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694355
• Other study ID #: sor0089-12-ctil
• Secondary ID: SCRC12008
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Signed Informed Consent.

2. Female age 55-70

3. At least 2 years past menopause

4. 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:

1. Mal-absorptive diseases (Cystic Fibrosis, Crohn's, gastric bypass surgery, celiac disease)

2. Rheumatoid arthritis

3. Nephrotic syndrome

4. Chronic renal failure

5. Primary hyperparathyroidism

6. Hyperthyroidism

7. Malignancies excluding skin cancers (within the last 5 years)

8. Kidney stones or history of renal colic 10. Medications:

9. Steroids use (past or present)

10. Anti rejection drugs in the last 5 years

11. Anticonvulsant (carbamezapine, hydantoin, Phenobarbital etc) in the last 5 years

12. Any anti osteoporotic medication: Prolia, Bisphosphonates, Teriperatide, Evista, Protelos, (past or present)

13. Post menopausal HRT (in the last 10 years)

14. Aromatase inhibitors: Femara, Arimadex (past or present)

15. Current use of PPIs (lanton, controloc, zoton, omepradex etc)

16. Current or past use of anti depressant SSRI (favoxil,cipralex etc)

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Be'er Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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