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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

55 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Soroka University Medical Center

Beersheba, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed Informed Consent.
Female age 55-70
At least 2 years past menopause
25(OH)D≤ 17.5nmol/L (≤7 ng/ml)

Exclusion criteria

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:

Mal-absorptive diseases (Cystic Fibrosis, Crohn's, gastric bypass surgery, celiac disease)
Rheumatoid arthritis
Nephrotic syndrome
Chronic renal failure
Primary hyperparathyroidism
Hyperthyroidism
Malignancies excluding skin cancers (within the last 5 years)
Kidney stones or history of renal colic 10. Medications:
Steroids use (past or present)
Anti rejection drugs in the last 5 years
Anticonvulsant (carbamezapine, hydantoin, Phenobarbital etc) in the last 5 years
Any anti osteoporotic medication: Prolia, Bisphosphonates, Teriperatide, Evista, Protelos, (past or present)
Post menopausal HRT (in the last 10 years)
Aromatase inhibitors: Femara, Arimadex (past or present)
Current use of PPIs (lanton, controloc, zoton, omepradex etc)
Current or past use of anti depressant SSRI (favoxil,cipralex etc)

Treatment and study plan

Vitamin D

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Acronym: Vitamin D

Important dates

Study start: 2012
Primary completion: 2018
Study completion: 2018
First posted: Sep 27, 2012
Registry last updated: Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed