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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: Vitamin D

• Registration Number: NCT01694355
• Lead Sponsor: Soroka University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-27
• Study Start: 2012-10
• Primary Completion: 2018-10
• Study Completion: 2018-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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:

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

3. Rheumatoid arthritis

4. Nephrotic syndrome

5. Chronic renal failure

6. Primary hyperparathyroidism

7. Hyperthyroidism

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

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

10. Steroids use (past or present)

11. Anti rejection drugs in the last 5 years

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

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

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

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

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D treatment	Vitamin D	We assume that among postmenopausal women, Vitamin D treatment will improve bone mineralization and will cause a rapid increase in BMD.

Primary Outcome Measures

Name	Time	Method
Change in BMD (Z score) following 10 months of vitamin D supplementation	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

Secondary Outcome Measures

Name	Time	Method
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.	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

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Be'er Sheva, Israel