Comparative evaluation of isosorbide mononitrate and alendronate in management of postmenopausal osteoporosis

Duhan, Nirmala; Siwach, Ram Chander; Yadav, Kiran; Dahiya, Kiran; Nanda, Smiti; Sirohiwal, Daya

doi:10.1007/s00404-011-2095-3

Cited by 5 publications

(8 citation statements)

References 12 publications

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“…There were no statistically significant differences in BMD percent change at any sites in these two RCTs compared with a placebo (14,15). In contrast, nitrates and alendronate had similar effects in increasing bone BMD in another two RCTs (16,25). NO is a short-lived free radical that regulates a variety of physiological processes, including bone remodeling (26).…”

Section: Discussionmentioning

confidence: 93%

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The Efficacy of Nitrates for Bone Health: A Systematic Review and Meta-Analysis of Observational and Randomized Controlled Studies

2022

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BackgroundAlthough some studies have found that nitrates were beneficial for bone health, the findings are inconsistent. To assess the efficacy of nitrates for bone health, we conducted a meta-analysis.MethodsPubMed, EMBASE databases, Cochrane Library for relevant articles published before December 2021 were searched. All observational and randomized controlled studies that reporting bone mineral density (BMD), fractures with nitrates use were included. A meta-analysis was performed to calculate risk ratios (RRs) for fractures, change differences for bone mineral density.ResultsFour cohort studies and two case-control studies examining the association between nitrates use and fractures were identified. The nitrates use was not associated with any fracture risk (RR = 0.97; 95% CI, 0.94–1.01; I2 = 31.5%) and hip fracture (RR = 0.88; 95% CI, 0.76–1.02; I2 = 74.5%). Subgroup analyses revealed no differences in fracture risk, whereas two cohort studies revealed a reduced risk of hip fracture (RR = 0.71, 95% CI, 0.58–0.86, I2 = 0.0%). There were no statistically significant differences in BMD percent changes at lumbar spine (WMD = -0.07, 95% CI,-0.78–0.65; I2 = 0.0%), total hip (WMD = -0.42, 95% CI,-0.88–0.04; I2 = 0.0%), femoral neck (WMD = -0.38, 95% CI,-1.02–0.25; I2 = 0.0%), or total body (WMD = -0.17, 95% CI,-0.51–0.17; I2 = 0.0%) in two randomized controlled trials (RCTs) compared with a placebo. Another two RCTs compared nitrates with alendronate. Nitrates were comparable to alendronate in increasing bone mineral density at lumbar spine (WMD = 0.00, 95% CI,-0.01–0.02; I2 = 0.0%). Besides, the most common adverse effect was headache, contributing to low adherence to therapy.ConclusionOur meta-analysis showed no association between nitrates use and fractures in observational studies. The results of RCTs on the usage of nitrates and their effects on BMD were inconsistent. High-quality, long-term studies are needed to clarify the efficacy of nitrates for bone health.

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Section: Discussionmentioning

confidence: 93%

“…However, one cohort study found no evidence that nitrate use was related to a decreased incidence of fractures or a higher BMD (13). Furthermore, the results of two randomized controlled trials (RCTs) that examined the effects of nitroglycerin ointment on BMD were contradictory (14)(15)(16).…”

Section: Introductionmentioning

confidence: 99%

The Efficacy of Nitrates for Bone Health: A Systematic Review and Meta-Analysis of Observational and Randomized Controlled Studies

2022

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“…(20) Another small trial of similar design reported extremely large increases in BMD with nitrates and alendronate over 9 months (8.8% versus 11.9%). (21) To our knowledge, the validity of these reports has not been independently examined. Finally, a 3-year trial in 186 postmenopausal women showed no effect of nitroglycerin ointment on BMD, but effects on bone turnover were not reported.…”

Section: Discussionmentioning

confidence: 98%

“…Both treatment groups had extremely large increases in BMD (10.8% versus 12.1%) over 1 year . Another small trial of similar design reported extremely large increases in BMD with nitrates and alendronate over 9 months (8.8% versus 11.9%) . To our knowledge, the validity of these reports has not been independently examined.…”

Section: Discussionmentioning

confidence: 99%

Nitrates Do Not Affect Bone Density or Bone Turnover in Postmenopausal Women: A Randomized Controlled Trial

Bolland

House

Horne

et al. 2020

Journal of Bone and Mineral Research

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Organic nitrates have been reported to have significant effects on bone mineral density (BMD) and bone turnover in previous clinical trials. However, results are inconsistent and some trials with strikingly positive results have been retracted because of scientific misconduct. As preparation for a potential fracture prevention study, we set out to determine the lowest effective dose and the most effective and acceptable nitrate preparation. We undertook a 1‐year, double‐blind, randomized, placebo‐controlled trial of three different nitrate preparations and two different doses in osteopenic postmenopausal women, with a planned 1‐year observational extension. The primary endpoint was change in BMD at the lumbar spine, and secondary endpoints included BMD changes at other sites, changes in bone turnover markers, and adverse events. A total of 240 eligible women who tolerated low‐dose oral nitrate treatment in a 2‐week run‐in period were randomized to five different treatment groups or placebo. Over 12 months, there were no statistically significant between‐group differences in changes in BMD at any site and no consistent differences in bone turnover markers. When the active treatment groups were pooled, there were also no differences in changes in BMD or bone turnover markers between nitrate treatment and placebo. Eighty‐eight (27%) women withdrew during the run‐in phase, with the majority because of nitrate‐induced headache, and 41 of 200 (21%) women randomized to nitrate treatment withdrew or stopped study medication during the 1‐year study compared with 1 of 40 (2.5%) in the placebo group. In summary, organic nitrates do not have clinically relevant effects on BMD or bone turnover in postmenopausal women and were poorly tolerated. These results call into question the validity of previous clinical research reporting large positive effects of nitrates on BMD and bone turnover. © 2020 American Society for Bone and Mineral Research.

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“…59 In a study designed to evaluate the role of isosorbide mononitrate and alendronate in the management of postmenopausal osteoporosis in Indian postmenopausal women, authors found an increase of almost 12% in the mean BMD at the lumbar spine after 9 months of treatment with alendronate. 60 However, in a study that aimed to evaluate the adherence and compliance of postmenopausal osteoporotic women for different regimens of bisphosphonates in Indian postmenopausal women, authors found that an adherence rate of 56% was found with the monthly regimens, 36% for weekly regimens, and 32% for daily regimens. Thus, the authors concluded that overall compliance for treatment was poor and that there was need for extensive pre- and continuous posttreatment counseling and follow-up.…”

Section: Treatment Of Osteoporosismentioning

confidence: 99%

Epidemiology and treatment of osteoporosis in women: an Indian perspective

Khadilkar¹,

Mandlik²

2015

IJWH

100

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The number of women with osteoporosis, ie, with reduced bone mass and the disruption of bone architecture, is increasing in India. While data on prevalence of osteoporosis among women in India come from studies conducted in small groups spread across the country, estimates suggest that of the 230 million Indians expected to be over the age of 50 years in 2015, 20%, ie, ~46 million, are women with osteoporosis. Thus, osteoporosis is a major public health problem in Indian women. Low calcium intakes with extensive prevalence of vitamin D deficiency, increasing longevity, sex inequality, early menopause, genetic predisposition, lack of diagnostic facilities, and poor knowledge of bone health have contributed toward the high prevalence of osteoporosis. Bone health may be optimized by creating an environment to achieve peak bone mass during adolescence, maintenance of healthy bone throughout the life cycle, and prevention of bone loss postmenopausal. In Indian women, calcium, vitamin D, and bisphosphonates are the commonest first-line therapies used. The use of other drugs such as hormone replacement therapy, estrogen agonists, calcitonin, parathyroid hormone, and denosumab is decided as per the affordability and availability of treatment options. Major gaps still remain in the diagnosis and management of osteoporosis, thus highlighting the need for more structured research in this area. This review focuses on the epidemiology of osteoporosis in Indian women and available treatments.

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Comparative evaluation of isosorbide mononitrate and alendronate in management of postmenopausal osteoporosis

Abstract: IMN has a beneficial effect on bone turnover in cases of postmenopausal osteoporosis and that the effect is comparable to that of alendronate. IMN is a promising and safe alternative to alendronate for the management of postmenopausal osteoporosis.

Cited by 5 publications

References 12 publications

The Efficacy of Nitrates for Bone Health: A Systematic Review and Meta-Analysis of Observational and Randomized Controlled Studies

The Efficacy of Nitrates for Bone Health: A Systematic Review and Meta-Analysis of Observational and Randomized Controlled Studies

Nitrates Do Not Affect Bone Density or Bone Turnover in Postmenopausal Women: A Randomized Controlled Trial

Epidemiology and treatment of osteoporosis in women: an Indian perspective

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Comparative evaluation of isosorbide mononitrate and alendronate in management of postmenopausal osteoporosis

Abstract: IMN has a beneficial effect on bone turnover in cases of postmenopausal osteoporosis and that the effect is comparable to that of alendronate. IMN is a promising and safe alternative to alendronate for the management of postmenopausal osteoporosis.

Cited by 5 publications

References 12 publications

The Efficacy of Nitrates for Bone Health: A Systematic Review and Meta-Analysis of Observational and Randomized Controlled Studies

The Efficacy of Nitrates for Bone Health: A Systematic Review and Meta-Analysis of Observational and Randomized Controlled Studies

Nitrates Do Not Affect Bone Density or Bone Turnover in Postmenopausal Women: A Randomized Controlled Trial

Epidemiology and treatment of osteoporosis in&nbsp;women: an Indian perspective

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Epidemiology and treatment of osteoporosis in women: an Indian perspective