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 Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Vitamin D

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Sheva, Israel
    • Soroka university medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: September 24, 2012
• First Submitted That Met QC Criteria: September 24, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: sor0089-12-ctil; SCRC12008 (Other Identifier: Soroka Clinical Research Center (SCRC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO