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

This study is currently recruiting participants.
Verified April 2016 by Merav Fraenkel, Soroka University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694355
First Posted: September 27, 2012
Last Update Posted: April 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Merav Fraenkel, Soroka University Medical Center
  Purpose

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.


Condition Intervention
Vitamin D Deficiency Drug: Vitamin D

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Merav Fraenkel, Soroka University Medical Center:

Primary Outcome Measures:
  • Change in BMD (Z score) following 10 months of vitamin D supplementation [ Time Frame: 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:
  • 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. [ Time Frame: 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


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694355


Locations
Israel
Soroka University Medical Center Recruiting
Be'er Sheva, Israel
Contact: Rita Troitsa       ritatr@clalit.org.il   
Principal Investigator: Merav Fraenkel, MD         
Sponsors and Collaborators
Soroka University Medical Center
  More Information

Responsible Party: Merav Fraenkel, Senior Endocrinologist, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01694355     History of Changes
Other Study ID Numbers: sor0089-12-ctil
SCRC12008 ( Other Identifier: Soroka Clinical Research Center (SCRC) )
First Submitted: September 24, 2012
First Posted: September 27, 2012
Last Update Posted: April 20, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents