Monthly Intramuscular Neridronate for the Treatment of Postmenopausal Osteoporosis: Results of a 6-Year Prospective Italian Study

Purpose. Oral bisphosphonates (BPs) are the most commonly used medications for osteoporosis (OP), but their poor gastrointestinal (GI) absorption and tolerance hamper compliance. Intramuscular (IM) neridronate (NE), an amino-BP, is an easy-to-administer, effective, and safe alternative to oral BPs. We assessed the 6-year effects of monthly IM NE on bone mineral density (BMD) and bone turnover biomarkers (BMs) in postmenopausal OP. Methods. This single-center, prospective study enrolled postmenopausal osteoporotic outpatients with gastric intolerance to BPs (based on Tuscany Region’s law GRT n. 836 20/10/2008). They received 25 mg IM NE once a month (with vitamin D and calcium if necessary) for 6 years. BMD was evaluated at lumbar spine (L1-L4), femoral neck (FN), and total femur (TF) at baseline (BL) and every 12 months afterwards. At BL, month 3, and every 12 months after BL, total and ionized calcium, vitamin D, parathyroid hormone 1-84, bone alkaline phosphatase (BALP), osteocalcin, and N- and C-terminal telopeptides were assayed. Results. Overall, 60 women (mean age: 62.3±7.5 years) received monthly IM NE for 6 years, with vitamin D and calcium supplementation in 81.3% of cases. Compared to BL, BMD increased significantly already after 1 year at all sites (4.5±0.9% for L1-L4, 4.5±0.8% for TF, and 2.1±0.6% for FN, P≤0.05), and the changes were maintained over time, whereas FN further improved up to year 3 and remained stable afterwards (P≤0.05). All BMs, except for total calcium and BALP, progressively decreased over time (P≤0.05). No fractures and significant adverse events were reported. Conclusion. The monthly administration of IM NE represents a manageable and effective option, in terms of BMD and bone BM improvement, for the long-term treatment of postmenopausal OP women with gastric intolerance to BPs. This trial is registered with ClinicalTrials.gov Identifier: NCT03699150.

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Adipose Tissue Remodeling by Prolonged Administration of High Dose of Vitamin D3 in Rats Treated to Prevent Sarcopenia

Revista de Chimie ◽

10.37358/rc.17.9.5842 ◽

2017 ◽

Vol 68 (9) ◽

pp. 2139-2143 ◽

Cited By ~ 1

Author(s):

Alin Constantin Pinzariu ◽

Sorin Aurelian Pasca ◽

Allia Sindilar ◽

Cristian Drochioi ◽

Mihail Balan ◽

...

Keyword(s):

Vitamin D ◽

Adipose Tissue ◽

Vitamin D3 ◽

Term Treatment ◽

High Dose ◽

Omental Adipose Tissue ◽

Long Term Treatment ◽

Male Wistar Rats ◽

Adipose Tissue Remodeling ◽

Visceral Adipose

To examine the effect of high dose vitamin D3 treatment on visceral adipose tissue, we used vitamin D deficient male Wistar rats (18 months old) as a model of sarcopenia. The aging process is not only responsive for the losing muscle mass but also for redistribution of lipid resulting in altered fatty acid storage and dysdifferentiation of mesenchymal precursors. The effect of aging and vitamin D treatment (weekly oral gavage with 0.125 mg vitamin D3 (5000 IU)/100g body weight) on the omental adipose tissue were histological examinated. At the end of the experiment (9 monhs), adaptive changes to the reduction of adipogenesis and increased apoptosis in response to long-term treatment with vitamin D consisted of smaller size of adipocyte and moderate macrophage infiltrate.

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Calcium and Vitamin D Supplementation. Myths and Realities with Regard to Cardiovascular Risk

Current Vascular Pharmacology ◽

10.2174/1570161117666190408165805 ◽

2019 ◽

Vol 17 (6) ◽

pp. 610-617 ◽

Cited By ~ 10

Author(s):

Giovanna Muscogiuri ◽

Luigi Barrea ◽

Barbara Altieri ◽

Carolina Di Somma ◽

Harjit pal Bhattoa ◽

...

Keyword(s):

Vitamin D ◽

Side Effects ◽

Secondary Hyperparathyroidism ◽

Calcium Supplementation ◽

Physiological Role ◽

Bone Diseases ◽

Current Evidence ◽

Bone Homeostasis ◽

Mineral Density ◽

Muscle Health

Vitamin D and calcium are considered crucial for the treatment of bone diseases. Both vitamin D and calcium contribute to bone homeostasis but also preserve muscle health by reducing the risk of falls and fractures. Low vitamin D concentrations result in secondary hyperparathyroidism and contribute to bone loss, although the development of secondary hyperparathyroidism varies, even in patients with severe vitamin D deficiency. Findings from observational studies have shown controversial results regarding the association between bone mineral density and vitamin D/calcium status, thus sparking a debate regarding optimum concentrations of 25-hydroxyvitamin D and calcium for the best possible skeletal health. Although most of the intervention studies reported a positive effect of supplementation with calcium and vitamin D on bone in patients with osteoporosis, this therapeutic approach has been a matter of debate regarding potential side effects on the cardiovascular (CV) system. Thus, the aim of this review is to consider the current evidence on the physiological role of vitamin D and calcium on bone and muscle health. Moreover, we provide an overview on observational and interventional studies that investigate the effect of vitamin D and calcium supplementation on bone health, also taking into account the possible CV side-effects. We also provide molecular insights on the effect of calcium plus vitamin D on the CV system.

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Long-term treatment with tibolone increases mean bone mineral density (BMD) in postmenopausal women,

Inpharma Weekly ◽

10.2165/00128413-200313750-00038 ◽

2003 ◽

Vol &NA; (1375) ◽

pp. 17

Author(s):

&NA;

Keyword(s):

Bone Mineral Density ◽

Postmenopausal Women ◽

Bone Mineral ◽

Term Treatment ◽

Mineral Density ◽

Long Term Treatment

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Efficacy and safety of long-term treatment with monthly calcifediol soft capsules in vitamin D deficient patients

Endocrine Abstracts ◽

10.1530/endoabs.73.aep83 ◽

2021 ◽

Author(s):

Jódar Esteban ◽

Jose Luis Perez-Castrillon ◽

Dueñas Antonio ◽

Gonzalo Hernandez ◽

Nieves Fernandez ◽

...

Keyword(s):

Vitamin D ◽

Term Treatment ◽

Efficacy And Safety ◽

Long Term Treatment

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The Effect of Calcium or Calcium and Vitamin D Supplementation on Bone Mineral Density in Healthy Males: A Systematic Review and Meta-Analysis

International Journal of Sport Nutrition and Exercise Metabolism ◽

10.1123/ijsnem.2014-0202 ◽

2015 ◽

Vol 25 (5) ◽

pp. 510-524 ◽

Cited By ~ 16

Author(s):

Leslie N. Silk ◽

David A. Greene ◽

Michael K. Baker

Keyword(s):

Bone Mineral Density ◽

Systematic Review ◽

Vitamin D ◽

Lumbar Spine ◽

Calcium Supplementation ◽

Meta Analysis ◽

Vitamin D Supplementation ◽

Mineral Density ◽

Total Body ◽

Healthy Males

Research examining the preventative effects of calcium and vitamin D supplementation has focused on children and females, leaving the effects on male bone mineral density (BMD) largely unexplored. Thus, the aim of this systematic review and meta-analysis is to examine the efficacy of calcium supplementation, with or without vitamin D for improving BMD in healthy males. Medline, EMBASE, SPORTDiscus, Academic Search Complete, CINHAHL Plus and PubMed databases were searched for studies including healthy males which provided participants calcium supplementation with or without vitamin D and used changes to BMD as the primary outcome measure. Between trial standardized mean differences of percentage change from baseline in BMD of femoral neck, lumbar spine, total body and total hip sites were calculated. Nine studies were included in the systematic review with six references totaling 867 participants contributing to the meta-analysis. Significant pooled effects size (ES) for comparison between supplementation and control groups were found at all sites included in the meta-analysis. The largest effect was found in total body (ES = 0.644; 95% CI = 0.406–0.883; p < .001), followed by total hip (ES = 0.483, 95% CI= 0.255–0.711, p < .001), femoral neck (ES = 0.402, 95% CI = 0.233–0.570, p = .000) and lumbar spine (ES = 0.306, 95% CI = 0.173–0.440, p < .001). Limited evidence appears to support the use of calcium and vitamin D supplementation for improving BMD in older males. There is a need for high quality randomized controlled trials, especially in younger and middle-aged male cohorts and athletic populations to determine whether supplementation provides a preventative benefit.

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Fresh frozen plasma as a source of plasminogen for ligneous conjunctivitis: Case report and a review of the literature

Journal of Clinical Research and Ophthalmology ◽

10.17352/2455-1414.000090 ◽

2021 ◽

pp. 031-035

Author(s):

Park Benjamin J ◽

Camoriano David ◽

Vital Mark C ◽

Chévez-Barrios Patricia ◽

Goosey John D ◽

...

Keyword(s):

Case Report ◽

Fresh Frozen Plasma ◽

Term Treatment ◽

Ligneous Conjunctivitis ◽

Caucasian Girl ◽

Long Term Treatment ◽

Effective Option ◽

Fresh Frozen ◽

Frozen Plasma

Purpose: To describe management of a patient with ligneous conjunctivitis secondary to plasminogen deficiency and review the literature on treatment with plasminogen. Design: Interventional case report. Methods: A 6-year-old Caucasian girl developed ligneous conjunctivitis recalcitrant to debridement and treatment with topical cyclosporin A and steroids. The literature was reviewed regarding treatment of ligneous conjunctivitis with plasminogen. Results: The patient was treated with plasminogen containing drops derived from her father’s fresh frozen plasma. The ligneous conjunctivitis resolved, and the patient was managed on these drops for the following 8 years, initiating treatment for flares and tapering according to clinical response. Conclusions: Plasminogen drops concentrated from fresh frozen plasma are a safe and effective option for long-term treatment of ligneous conjunctivitis.

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Effects of denosumab in Japanese rheumatoid arthritis patients treated with conventional anti-rheumatic drugs: 36-month extension of a phase 3 study

The Journal of Rheumatology ◽

10.3899/jrheum.201376 ◽

2021 ◽

pp. jrheum.201376

Author(s):

Yoshiya Tanaka ◽

Tsutomu Takeuchi ◽

Satoshi Soen ◽

Hisashi Yamanaka ◽

Toshiyuki Yoneda ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Type I Collagen ◽

Joint Destruction ◽

Term Treatment ◽

Drug Discontinuation ◽

Type I ◽

Mineral Density ◽

Phase 3 ◽

Long Term Treatment

Objective To evaluate safety and efficacy of long-term denosumab 60 mg every 6 (Q6M) or 3 months (Q3M) in rheumatoid arthritis (RA) patients. Methods This 12-month, randomised, double-blind, placebo-controlled, multicentre phase 3 trial with an open-label extension period from 12 to 36 months (DESIRABLE) enrolled Japanese RA patients treated with placebo for 12 months then denosumab Q6M (P/Q6M) or denosumab Q3M (P/Q3M); denosumab Q6M for 36 months (Q6M/Q6M); or denosumab Q3M for 36 months (Q3M/Q3M). Efficacy was assessed by van der Heijde modified total Sharp (mTSS), bone erosion (ES), and joint space narrowing (JSN) scores. Results Long-term treatment better maintained mTSS and ES suppression in the P/Q3M and Q3M/Q3M versus P/Q6M and Q6M/Q6M groups; changes from baseline in total mTSS at 36 months were 2.8 (standard error 0.4), 1.7 (0.3), 3.0 (0.4), and 2.4 (0.3), respectively; corresponding changes in ES were 1.3 (0.2), 0.4 (0.2), 1.4 (0.2), and 1.1 (0.2). No JSN effect was observed. Bone mineral density consistently increased in all groups after denosumab initiation, regardless of concomitant glucocorticoid administration. Serum C-telopeptide of type I collagen decreased rapidly at 1-month post-denosumab administration (both in the initial 12- month [Q3M, Q6M groups] and long-term treatment [P/Q3M, P/Q6M groups] phases). Adverse event incidence leading to study drug discontinuation was similar across treatment groups. Conclusion Denosumab treatment maintained inhibition of progression of joint destruction up to 36 months. Based on effects on ES progression, higher dosing frequency at an earlier treatment stage may be needed to optimise treatment. Denosumab was generally well tolerated.

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