calcium

This JAMA Patient Page describes the use of cardiac computed tomography scans to look for calcium in the coronary arteries as a predictor of future atherosclerotic cardiovascular disease events.

Author/s:

Kristin L Walter

The Women’s Health Initiative Randomized Trials and Clinical Practice

Alex Haga — Mon, 13 May 2024 21:25:57 +0000

Date Added:

May 13, 2024

Journal/Publication:

JAMA

Publisher:

JAMA

Publication Date:

May 1, 2024

URL:

The Women’s Health Initiative Randomized Trials and Clinical Practice

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jama.2024.6542

Keywords

PMID (1):

38691368

A summary review of the results of the Womens Health Initiative Study pertaining to HRT, Vit D/calcium supplementation, and low-fat diet in menopausal women. James W. Mold, MD, MPH

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Importance: Approximately 55 million people in the US and approximately 1.1 billion people worldwide are postmenopausal women. To inform clinical practice about the health effects of menopausal hormone therapy, calcium plus vitamin D supplementation, and a low-fat dietary pattern, the Women's Health Initiative (WHI) enrolled 161 808 postmenopausal US women (N = 68 132 in the clinical trials) aged 50 to 79 years at baseline from 1993 to 1998, and followed them up for up to 20 years.

Observations: The WHI clinical trial results do not support hormone therapy with oral conjugated equine estrogens plus medroxyprogesterone acetate for postmenopausal women or conjugated equine estrogens alone for those with prior hysterectomy to prevent cardiovascular disease, dementia, or other chronic diseases. However, hormone therapy is effective for treating moderate to severe vasomotor and other menopausal symptoms. These benefits of hormone therapy in early menopause, combined with lower rates of adverse effects of hormone therapy in early compared with later menopause, support initiation of hormone therapy before age 60 years for women without contraindications to hormone therapy who have bothersome menopausal symptoms. The WHI results do not support routinely recommending calcium plus vitamin D supplementation for fracture prevention in all postmenopausal women. However, calcium and vitamin D are appropriate for women who do not meet national guidelines for recommended intakes of these nutrients through diet. A low-fat dietary pattern with increased fruit, vegetable, and grain consumption did not prevent the primary outcomes of breast or colorectal cancer but was associated with lower rates of the secondary outcome of breast cancer mortality during long-term follow-up.

Conclusions and relevance: For postmenopausal women, the WHI randomized clinical trials do not support menopausal hormone therapy to prevent cardiovascular disease or other chronic diseases. Menopausal hormone therapy is appropriate to treat bothersome vasomotor symptoms among women in early menopause, without contraindications, who are interested in taking hormone therapy. The WHI evidence does not support routine supplementation with calcium plus vitamin D for menopausal women to prevent fractures or a low-fat diet with increased fruits, vegetables, and grains to prevent breast or colorectal cancer. A potential role of a low-fat dietary pattern in reducing breast cancer mortality, a secondary outcome, warrants further study.

Author/s:

Manson, J.E., Crandall, C.J., Rossouw, J.E.

Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

Saige Blanchard — Tue, 07 Jun 2022 05:00:00 +0000

Date Added:

June 7, 2022

Journal/Publication:

Cochrane Database of Systematic Reviews

Publisher:

John Wiley & Sons, Ltd.

Publication Date:

May 3, 2022

URL:

Risedronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1002/14651858.CD004523.pub4

Keywords

PMID (1):

35502787

MeSH

Risedronic Acid

spinal fractures

osteoporotic fractures

calcium

Drug Approval

A concise summary of a Cochrane Collaboration review of evidence of the effectiveness of risedronate for primary and secondary prevention of fractures. James W. Mold, MD, MPH

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Background: Osteoporosis is an abnormal reduction in bone mass and bone deterioration leading to increased fracture risk. Risedronate belongs to the bisphosphonate class of drugs which act to inhibit bone resorption by interfering with the activity of osteoclasts. This is an update of a Cochrane Review that was originally published in 2003.

Objectives: We assessed the benefits and harms of risedronate in the primary and secondary prevention of osteoporotic fractures for postmenopausal women at lower and higher risk for fractures, respectively.

Search methods: With broader and updated strategies, we searched the Cochrane Central Register of Control Trials (CENTRAL), MEDLINE and Embase. A grey literature search, including the online databases ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), and drug approval agencies, as well as bibliography checks of relevant systematic reviews was also performed. Eligible trials published between 1966 to 24 March 2021 were identified.

Selection criteria: We included randomised controlled trials that assessed the benefits and harms of risedronate in the prevention of fractures for postmenopausal women. Participants must have received at least one year of risedronate, placebo or other anti-osteoporotic drugs, with or without concurrent calcium/vitamin D. Major outcomes were clinical vertebral, non-vertebral, hip and wrist fractures, withdrawals due to adverse events, and serious adverse events. In the interest of clinical relevance and applicability, we classified a study as secondary prevention if its population fulfilled more than one of the following hierarchical criteria: a diagnosis of osteoporosis, a history of vertebral fractures, low bone mineral density (BMD)T score ≤ -2.5, and age ≥ 75 years old. If none of these criteria was met, the study was considered to be primary prevention.

Data collection and analysis: We used standard methodology expected by Cochrane. We pooled the relative risk (RR) of fractures using a fixed-effect model based on the expectation that the clinical and methodological characteristics of the respective primary and secondary prevention studies would be homogeneous, and the experience from the previous review suggesting that there would be a small number of studies. The base case included the data available for the longest treatment period in each placebo-controlled trial and a >15% relative change was considered clinically important. The main findings of the review were presented in summary of findings tables, using the GRADE approach. In addition, we looked at benefit and harm comparisons between different dosage regimens for risedronate and between risedronate and other anti-osteoporotic drugs.

Main results: Forty-three trials fulfilled the eligibility criteria, among which 33 studies (27,348 participants) reported data that could be extracted and quantitatively synthesized. We had concerns about particular domains of risk of bias in each trial. Selection bias was the most frequent concern, with only 24% of the studies describing appropriate methods for both sequence generation and allocation concealment. Fifty per cent and 39% of the studies reporting benefit and harm outcomes, respectively, were subject to high risk. None of the studies included in the quantitative syntheses were judged to be at low risk of bias in all seven domains. The results described below pertain to the comparisons for daily risedronate 5 mg versus placebo which reported major outcomes. Other comparisons are described in the full text. For primary prevention, low- to very low-certainty evidence was collected from four studies (one to two years in length) including 989 postmenopausal women at lower risk of fractures. Risedronate 5 mg/day may make little or no difference to wrist fractures [RR 0.48 ( 95% CI 0.03 to 7.50; two studies, 243 participants); absolute risk reduction (ARR) 0.6% fewer (95% CI 1% fewer to 7% more)] and withdrawals due to adverse events [RR 0.67 (95% CI 0.38 to 1.18; three studies, 748 participants); ARR 2% fewer (95% CI 5% fewer to 1% more)], based on low-certainty evidence. However, its preventive effects on non-vertebral fractures and serious adverse events are not known due to the very low-certainty evidence. There were zero clinical vertebral and hip fractures reported therefore the effects of risedronate for these outcomes are not estimable. For secondary prevention, nine studies (one to three years in length) including 14,354 postmenopausal women at higher risk of fractures provided evidence. Risedronate 5 mg/day probably prevents non-vertebral fractures [RR 0.80 (95% CI 0.72 to 0.90; six studies, 12,173 participants); RRR 20% (95% CI 10% to 28%) and ARR 2% fewer (95% CI 1% fewer to 3% fewer), moderate certainty], and may reduce hip fractures [RR 0.73 (95% CI 0.56 to 0.94); RRR 27% (95% CI 6% to 44%) and ARR 1% fewer (95% CI 0.2% fewer to 1% fewer), low certainty]. Both of these effects are probably clinically important. However, risedronate's effects are not known for wrist fractures [RR 0.64 (95% CI 0.33 to 1.24); three studies,1746 participants); ARR 1% fewer (95% CI 2% fewer to 1% more), very-low certainty] and not estimable for clinical vertebral fractures due to zero events reported (low certainty). Risedronate results in little to no difference in withdrawals due to adverse events [RR 0.98 (95% CI 0.90 to 1.07; eight studies, 9529 participants); ARR 0.3% fewer (95% CI 2% fewer to 1% more); 16.9% in risedronate versus 17.2% in control, high certainty] and probably results in little to no difference in serious adverse events [RR 1.00 (95% CI 0.94 to 1.07; six studies, 9435 participants); ARR 0% fewer (95% CI 2% fewer to 2% more; 29.2% in both groups, moderate certainty).

Authors' conclusions: This update recaps the key findings from our previous review that, for secondary prevention, risedronate 5 mg/day probably prevents non-vertebral fracture, and may reduce the risk of hip fractures. We are uncertain on whether risedronate 5mg/day reduces clinical vertebral and wrist fractures. Compared to placebo, risedronate probably does not increase the risk of serious adverse events. For primary prevention, the benefit and harms of risedronate were supported by limited evidence with high uncertainty.

Author/s:

Wells, G. A., Hsieh, S., Zheng, C., Peterson, J., Tugwell, P., Liu, W.

Vitamin D Deficiency in Children and Its Management: Review of Current Knowledge and Recommendations

Bethie Seay — Fri, 03 Sep 2021 05:00:00 +0000

Date Added:

September 3, 2021

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.1542/peds.2007-1894

MeSH

Pharmacy and Therapeutics Committee

Pharmaceutical Preparations

Breast Feeding

calcium

supplements

A guideline for Vitamin D supplementation in children from the Pediatric Endocrinologic Association.

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Given the recent spate of reports of vitamin D deficiency, there is a need to
reexamine our understanding of natural and other sources of vitamin D, as well as
mechanisms whereby vitamin D synthesis and intake can be optimized. This state-of-the-art report from the Drug and Therapeutics Committee of the Lawson Wilkins
Pediatric Endocrine Society was aimed to perform this task and also reviews recommendations for sun exposure and vitamin D intake and possible caveats associated
with these recommendations. Pediatrics 2008;122:398–417

Author/s:

Misra, M., Pacaud, D., Petryk, A., Collett-Solberg, P. F., Kappy, M.

The effect of high-dose vitamin D supplementation on serum vitamin D levels and milk calcium concentration in lactating women and their infants

Bethie Seay — Fri, 03 Sep 2021 05:00:00 +0000

Date Added:

September 3, 2021

Type:

Clinical Research Results

DOI (1):

10.1089/bfm.2006.1.27

PMID (1):

17661558

MeSH

Adult

Bone Density Conservation Agents

calcium

dietary supplements

Dose-Response Relationship

Infant Nutritional Physiological Phenomena

infant, newborn

Lactation

Maternal Nutritional Physiological Phenomena

Milk, Human

Nutritional Requirements

Nutritional Status

prospective studies

vitamin D

This study provides guidance on Vitamin D supplementation in lactating women and their babies.

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Objective: Improve vitamin D status in lactating women and their recipient infants, and measure breast milk calcium concentration [Ca] as a function of vitamin D regimen.

Design/methods: Fully breastfeeding mothers were randomized at 1 month postpartum to 2000 (n = 12) or 4000 (n = 13) IU/day vitamin D for 3 months to achieve optimal vitamin D status [serum 25(OH)D > or =32 ng/mL (80 nmol/L)]. Breast milk [Ca], maternal and infant serum 25(OH)D and serum Ca, and maternal urinary Ca/Cr ratio were measured monthly.

Results: Mothers were similar between groups for age, race, gestation, and birth weight. 25(OH)D increased from 1 to 4 months in both groups (mean +/- SD): +11.5 +/- 2.3 ng/mL for group 2000 (p = 0.002) and +14.4 +/- 3.0 ng/mL for group 4000 (p = 0.0008). The 4000 IU/day regimen was more effective in raising both maternal and infant serum levels and breast milk antirachitic activity than the 2000 IU/day regimen. Breast milk [Ca] fell with continued lactation through 4 months in the 2000 and 4000 IU groups. Decline in breast milk [Ca] was not associated with vitamin D dose (p = 0.73) or maternal 25(OH)D (p = 0.94). No mother or infant experienced vitamin D-related adverse events, and all laboratory parameters remained in the normal range.

Conclusion: High-dose vitamin D was effective in increasing 25(OH)D levels in fully breastfeeding mothers to optimal levels without evidence of toxicity. Breast milk [Ca] and its decline in both groups during 1 to 4 months were independent of maternal vitamin D status and regimen. Both the mother and her infant attained improved vitamin D status and maintained normal [Ca].

Author/s:

Basile, L. A., Taylor, S. N., Wagner, C. L., Horst, R. L., Hollis, B. W.

The Effect of Aged Garlic Extract on the Atherosclerotic Process - A Randomized Double-Blind Placebo-Controlled Trial

Brian Desmarais — Sat, 02 May 2020 19:53:28 +0000

Date Added:

May 2, 2020

Journal/Publication:

BMC Complimentary Medicine and Therapies

Publication Date:

May 29, 2020

Issue:

Volume:

Pages:

132

URL:

The Effect of Aged Garlic Extract on the Atherosclerotic Process - A Randomized Double-Blind Placebo-Controlled Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

https://doi.org/10.1186/s12906-020-02932-5

Keywords

MeSH

Blood Pressure Monitoring

Blood Pressure Determination

datamining

antioxidants

data management

Aged garlic extract, widely available in stores and online, seems to have antiatherogenic properties. James W. Mold, MD, MPH

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Background: One of the most serious secondary manifestations of Cardiovascular Disease (CVD) is coronary atherosclerosis. This study aimed to evaluate whether aged garlic extract (AGE) can influence coronary artery calcification (CAC) and to predict the individual effect of AGE using a standard process for data mining (CRISP-DM).

Method: This was a single-center parallel randomized controlled study in a university hospital in Europe. Patients were randomized, in a double-blind manner, through a computer-generated randomization chart. Patients with a Framingham risk score ≥ 10 after CT scan (n = 104) were randomized to an intake of placebo or AGE (2400 mg daily) for 1 year. Main outcome measures were changes in CAC score and secondary outcome measures changes in blood pressure, fasting blood glucose, blood lipids and inflammatory biomarkers.

Result: 104 patients were randomized and 46 in the active group and 47 in the placebo group were analyzed. There was a significant (p < 0.05) change in CAC progression (OR: 2.95 [1.05-8.27]), blood glucose (OR: 3.1 [1.09-8.85]) and IL-6 (OR 2.56 [1.00-6.53]) in favor of the active group. There was also a significant (p = 0.027) decrease in systolic blood pressure in the AGE group, from a mean of 148 (SD: 19) mmHg at 0 months, to 140 (SD: 15) mmHg after 12 months. The AGE Algorithm, at a selected probability cut-off value of 0.5, the accuracy score for CAC progression was 80%, precision score of 79% and recall score 83%. The score for blood pressure was 74% (accuracy, precision and recall). There were no side-effects in either group.

Conclusions: AGE inhibits CAC progression, lowers IL-6, glucose levels and blood pressure in patients at increased risk of cardiovascular events in a European cohort. An algorithm was made and was used to predict with 80% precision which patient will have a significantly reduced CAC progression using AGE. The algorithm could also predict with a 74% precision which patient will have a significant blood pressure lowering effect pressure using AGE.

Trial registration: Clinical trials NCT03860350, retrospectively registered (1/32019).

Keywords: Aged garlic extract; Blood pressure; CRISP-DM; Calcium score; Data mining; Data science; Double-blinded; Placebo-controlled.

Author/s:

Wlosinska, M., Nilsson, A., Hlebowicz, J., Hauggaard, A., Fakhro, M., Lindstedt, S.