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

NCT01694355 | Completed

• 2 other identifiers: sor0089-12-ctilSCRC12008
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

  10-14 months

Study Arms (1)

Vitamin D treatment

EXPERIMENTAL

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

Drug: Vitamin D

Interventions

Vitamin D DRUG

Vitamin D treatment

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Endocrinologist

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)