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

NCT ID: NCT01694355

Last Updated: 2019-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2018-12-31

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D treatment

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

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Interventions

Vitamin D

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Merav Fraenkel

Senior Endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Soroka University Medical Center

Beersheba, , Israel

Countries

Israel

Other Identifiers

SCRC12008

Identifier Type: OTHER

Identifier Source: secondary_id

sor0089-12-ctil

Identifier Type: -

Identifier Source: org_study_id