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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Soroka University Medical Center
Sponsor:
Information provided by (Responsible Party):
Merav Fraenkel, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01694355
First received: September 24, 2012
Last updated: March 23, 2014
Last verified: March 2014
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Change in BMD (Z score) following 10 months of vitamin D supplementation [ Time Frame: 10-14 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Primary Completion Date: October 2014 (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

Ages Eligible for Study:   55 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 24, 2012
Last Updated: March 23, 2014
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on August 21, 2014