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EFFECT OF ORAL VITAMIN D SUPPLEMENT ON THE TREATMENT OF OSTEOPOROSIS IN POST-MENOPAUSAL WOMEN OVER 65 YEARS OLD: A SYSTEMATIC REVIEW OF RANDOMISED CONTROLLED TRIAL
Table of Contents
ABSTRACT    3
Background    3
Objective    3
Study Design    3
Results    3
Conclusion    3
Key Terms    4
INTRODUCTION    4
METHODS    5
Search Strategy    5
Search Selection    5
Data Abstraction and Collection    6
Article 1    6
Article 2    7
Article 3    7
Article 4    8
Article 5    8
Article 6    9
Article 7    10
Article 8    10
Method of Comparison of Results    11
RESULTS    11
Article 1    11
Article 2    12
Article 3    12
Article 4    12
DISCUSSION AND CONCLUSION    15
REFERENCES    18
ABSTRACT
Background
Women at the age of sixty and above often suffered from the osteoporosis. Osteoporosis is a degenerative disease, which occur mostly in the ageing people. Osteoporosis resulted in the weak and fragile bones, which make individual prone to fractures. In women, osteoporosis occurs due to lowering of the amount of the oestrogen in body. This usually happens when women undergo menopause. Oral vitamin D supplementation is prescribed to the post-menopausal women undergoing treatment for the osteoporosis. Worldwide, vitamin D supplement is considered one of the necessary supplements to support the bones of the body.
Objective
This systematic review aims to determine the safety and therapeutic effect of vitamin D supplement on osteoporosis in post-menopausal women aged 65 years
Study Design
A systematic review of randomised controlled trials (RCTs) is done. PubMed database was used to search the relevant randomised controlled trials.
Results
Ten publications that include eight trials met the selection criteria. Only four trials are included as they match the complete criteria for the purpose of the study. Four included trials reported the safety and clinical outcomes of the vitamin D on the women post menopause. The intake of the oral vitamin D supplementation along with the therapies or calcium supplement shows the positive effect on the women suffering from osteoporosis. It reduces the risk of frequent fractures. There were no direct proofs that vitamin D supplement alone can support the bone density and reduces the vulnerability in women post-menopause. The specific amount of dosage needs to be given to women for the effectiveness of the supplement on the body. None of the remaining four studies reported the impact of the vitamin D supplement on the body. Effect of the vitamin D supplement on body alone is inconsistent.
Conclusion
In this review, we highlight the lack of the quality evidences, which proof that the oral vitamin D supplementation have effect on the osteoporosis. Although, some of the random clinical trials address the effect of the oral vitamin D supplementation on the bone density depending upon the amount of dosage administered in the body on daily basis.
Key Terms
Vitamin D supplement, Osteoporosis, post-menopause, and women
INTRODUCTION
Osteoporosis is one of the major public health issues, which resulted in manifestation of the loss of the bone minerals in the people resulted in the increase in the risks of fractures and falls. This disease is mainly associated with the age. Ageing adults irrespective of the gender often become victim of the osteoporosis (1). There are many factors, which are associated with the risk of osteoporosis in the people. These risks include age, female sex, oestrogen deficiency, androgen deficiency and ethnicity. The women post-menopause is at higher risk of osteoporosis because of the lowering of the oestrogen level in the body (2).
It has been seen that people with vitamin D deficiency and calcium deficiency are at higher risk of weak bones. People worldwide have accepted that oral vitamin D supplementation is helpful in improving the bone density and it must be prescribed to the post-menopausal women suffering from osteoporosis (3). Osteoporosis have high impact on the spine, hip, and wrist, other bones are also affected from the disease. There are no early signs and symptoms of the disease until persons either suffering from the disease fall or suffered from fractured. Most of the treatment for the osteoporosis includes prescription of medication rich in calcium and vitamin D (4).
It has been seen that use of the oral supplements are first-line of treatment for postmenopausal osteoporosis. These supplements have documented preventive effect on fracture at multiple sites by increasing the bone density. The recommended dosage of the oral vitamin D supplement when taken on daily basis has shown the significant improve on the patients suffering from osteoporosis (5). Oral vitamin D supplements are usually coupled with calcium supplement or other therapies to improve the condition of the patient.
Osteoporosis and its associated morbidity have become the persistent health issue as women above the age of 50 have high vulnerability towards the disease. It is recommended to couple Vitamin D supplementation with antiresorptive therapy, and calcium intake (6). Vitamin D plays an important role in calcium metabolism, improvement of bone health, and muscle strength. Calcium supplementation reduces the risk of fractures and increases lower extremity strength, all these effects are dose dependent. It has been seen that women despite been living in the tropical region are recommended moderate dose of vitamin D supplement when suffered from osteoporosis (7).
Hypovitaminosis D has now become global concern. The reason for this study is to study the impact of vitamin D on the body, as worldwide; there is high use of oral vitamin D supplements for the post-menopausal women suffering from osteoporosis. There is gap in the study, which shows the consistency of the oral vitamin D supplements alone to have improved outcome on the women suffering from osteoporosis (8). There can be negative effect of excessive use of oral vitamin D supplementation. The objective of this study is the conduction of the systematic review aims to determine the safety and therapeutic effect of vitamin D supplement on osteoporosis in post-menopausal women aged 65 years.
METHODS
Search Strategy
I searched the PubMed from 2014 Aug 07 to 2019 Aug 05. The following search terms were used:
("osteoporosis, postmenopausal"[MeSH Terms] OR ("osteoporosis"[TIAB] AND "postmenopausal"[TIAB]) OR "postmenopausal osteoporosis"[TIAB] OR "osteoporosis"[TIAB] OR "osteoporosis"[MeSH Terms]) AND ("vitamin d"[MeSH Terms] OR "vitamin d"[TIAB] OR "ergocalciferols"[MeSH Terms] OR "ergocalciferols"[TIAB]) AND (Randomised Controlled Trial[ptyp] AND "loattrfree full text"[sb] AND "2014/08/07"[PDat] : "2019/08/05"[PDat] AND "humans"[MeSH Terms] AND English[lang] AND "female"[MeSH Terms] AND "aged"[MeSH Terms])
Search Selection
The search returned a total of 30 publications. Of these, 22 publications were excluded because these studies did not meet the predefined inclusion criteria. A total of 8 trials were included in the review. All the RCTs (Randomised Controlled Trial) had been selected. All the eight studies have shown the effects of vitamin D, and only women with menopause and osteoporosis are eligible for inclusion in the review. The experiment received oral vitamin D, alendronate sodium and oral calcium and other growth hormone placebo.
The only difference between the treatment group and the control group is the presence or absence of vitamin D. The main result is to explore the effects of oral vitamin D and similar growth hormone drugs on women with menopausal osteoporosis. Focus is made on the menopausal women at the age of 65 and above irrespective of their ethnicity was included in the study. Only trials were eligible in the inclusion, which provides the oral supplements of the Vitamin D coupling with or without other supplements, along with the comparison to be done between groups based on present and absent of the supplement of oral vitamin D.
Search was restricted to the human languages without the restriction of the language. Reference list of reputed publications were included in the search. There is addition of the recent articles for the additional studies. It is necessary to note that abstracts and titles of all the articles were analysed for the eligibility criteria and final selection is done consisting four articles eligible for the study. Other factors, which become the reason for the exclusion of the article, include insufficient information in the abstract and inability to access the article for the study.
Data Abstraction and Collection
For the data abstraction and collection, specific data from the abstract of all the articles are selected and then compared to decide which articles need to be included and which needs to be excluded from the study. The data, which is extracted, include objective of the study, methodology, sample size, interventions, statistical analysis method, interpretation of the results and results.
Article 1
Objective of the study: This study aimed to explore clinical characteristics associated with 12-month BMD improvement in Chinese women with postmenopausal osteoporosis (PMO) (9).
Methodology: Randomised controlled trial, Chinese PMO women was conducted (9).
Sample size: 219 women Chinese osteoporosis patients, who were aged >55 years and postmenopausal for at least 1 year were selected (9).
Interventions: All patients (n=96) with on-treatment BTM (P1NP/s-CTx) and 1-year LS-BMD measurements were eligible for analysis. The phase 3 RCT had statistically 97% power (2-sided, a=0.05) to demonstrate the primary hypothesis that treatment with ALN/D5600 was superior to treatment with calcitriol assuming that the treatment difference in BMD percent change between ALN/D5600 IU and calcitriol is 2% (9).
Results: The presented findings from Chinese postmenopausal osteoporotic women suggested clinically meaningful baseline and on-treatment characteristics predicting BMD improvement after 1 year of ALN/D5600 treatment, which differed from calcitriol treatment with baseline identifiable associations (9).
Article 2
Objective of the study: The present study aimed to investigate 25-hydroxyvitamin D [25(OH) D] improvement and calcium-phosphate metabolism in Chinese PMO patients treated with 70 mg of alendronate sodium and 5600 IU of vitamin D3 (ALN/D5600) (10).
Methodology: Chinese PMO women (n = 219) were treated with 12-month ALN/D5600 (n = 111) or calcitriol (n = 108). Changes in 25(OH) D at month 12 were post hoc analysed by the baseline 25 (OH) D status using the...