A randomized, open-label, controlled trial of monthly oral minodronate or semiannual subcutaneous injection of denosumab for bone loss by androgen deprivation in Asian men with prostate cancer: the PRevention of Osteopenia with Minodronate And DEnosumab (PROMADE) study

This study showed that both drugs significantly improved lumbar spine and total hip bone mineral density in Asian men with prostate cancer who received ADT.IntroductionTo evaluate whether monthly oral minodronate or semiannual subcutaneous injection of denosumab improves bone mineral density (BMD) in Asian men with prostate cancer (PCa) receiving ADT.MethodsA multicenter, open-label, randomized, controlled study including patients with hormone-sensitive PCa without bone metastasis receiving ADT was performed. Patients were randomized (1:1:1) to minodronate, denosumab, or no agent control groups. The primary end point was the mean percentage change in BMD at the lumbar spine at 12  months. Secondary end points were the mean percentage change in BMD at the femoral neck and total hip and changes in bone turnover markers. Statistical comparison was performed using analysis of covariance.ResultsOf the 147 subjects enrolled in this study, 102 were randomly assigned into the minodronate (n = 36), denosumab (n = 36), and control (n = 30) groups. The percentage change in BMD at the lumbar spine was significantly improved in the minodronate (2.5%,p 
Source: Osteoporosis International - Category: Orthopaedics Source Type: research

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Conclusiones: El tratamiento de la OMAM depende del estadio de la enfermedad; la mandibulectomía es un tratamiento efectivo en el estadio 3 y la secuestrectomía en el estadio 2; el estadio 1 suele controlarse con tratamiento conservador.ABSTRACT Introduction: Bisphosphonates are a family of drugs used to inhibit bone resorption. One of their secondary effects is osteonecrosis of the jaws (ONJ). In 2010, scientists began to publish cases of osteonecrosis of the jaws associated with a new drug, denosumab. In 2014 it was recommended to change the name of ONJ to medication-related osteonecrosis of the jaws (MONJ)...
Source: Revista Espanola de Cirugia Oral y Maxilofacial - Category: ENT & OMF Source Type: research
CONCLUSIONS: Prophylaxis of MRONJOne open-label RCT provided some evidence that dental examinations in three-month intervals and preventive treatments may be more effective than standard care for reducing the incidence of MRONJ in individuals taking intravenous bisphosphonates for advanced cancer. We assessed the certainty of the evidence to be low.There is insufficient evidence to either claim or refute a benefit of either of the interventions tested for prophylaxis of MRONJ (i.e. PRGF inserted into the postextraction alveolus during dental extractions, and wound closure by primary or secondary intention after dental extr...
Source: Cochrane Database of Systematic Reviews - Category: General Medicine Authors: Tags: Cochrane Database Syst Rev Source Type: research
Conclusions: In this cohort of women with elevated risk, high serum 25(OH)D levels and regular vitamin D supplement use were associated with lower rates of incident, postmenopausal breast cancer over 5 y of follow-up. These results may help to establish clinical benchmarks for 25(OH)D levels; in addition, they support the hypothesis that vitamin D supplementation is useful in breast cancer prevention. https://doi.org/10.1289/EHP943 About This Article Received: 09 August 2016 Revised: 23 January 2017 Accepted: 06 February 2017 Published: 06 July 2017 Address correspondence to C. R. Weinberg, 111 TW Alexander Dr., Rese...
Source: EHP Research - Category: Environmental Health Authors: Tags: Research Source Type: research
CONCLUSION: In patients receiving continuous bisphosphonate therapy, any treatment procedure (invasive or non-invasive) that compromises the integrity of the tissue should be performed with caution owing to the possibility of developing osteonecrosis.
Source: Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics - Category: ENT & OMF Authors: Tags: Poster presentation Source Type: research
Conclusion: Treatment options for the defects resulting from MRONJ are still under debate, and no evidence-based guidelines are available. However, due to the results displayed in this patient; it may be a sound approach to closely follow up and observe MRONJ-related bone to prevent additional complications.
Source: Journal of Craniofacial Surgery - Category: Surgery Tags: Brief Clinical Studies Source Type: research
We report a case of denosumab-induced hypocalcemia to highlight potential toxicity and treatment considerations. A 66-year-old man with prostate cancer, small cell lung cancer, and bone metastases presented with fatigue, weakness, and muscle spasm. Sixteen days prior, he received cycle 6 of cisplatin and etoposide, leuprolide, and denosumab (120 mg subcutaneously). His examination demonstrated a slight resting tremor, normal strength, and negative Chvostek sign. Laboratory analysis revealed hemoglobin, 8.0 g/dL; total calcium, 5.2 mg/dL (pre-denosumab, 8.9 mg/dL); and magnesium, 0.7 mg/dL. He initi...
Source: Journal of Medical Toxicology - Category: Toxicology Authors: Tags: J Med Toxicol Source Type: research
CONCLUSIONS: It is concluded that the highest number of ONJ cases caused by the use of anti-RANKL agents occurred in female patients, aged 60 years or older, under treatment for osteoporosis and cancer metastasis, and the most affected region was the mandible posterior. PMID: 26827069 [PubMed - as supplied by publisher]
Source: Medicina Oral, Patologia Oral y Cirugia Bucal - Category: ENT & OMF Tags: Med Oral Patol Oral Cir Bucal Source Type: research
Authors: Gavaldá C, Bagán JV Abstract Bisphosphonates (BPs) and other antiresorptive agents such as denosumab are widely prescribed for the treatment of osteoporosis and are also used in patients with multiple myeloma and metastatic breast or prostate cancer for avoiding bone reabsorption and fractures that result in increased morbidity-mortality among such individuals. Osteonecrosis of the jaws (ONJ) is an important complication of exposure to BPs or other antiresorptive agents, and although its prevalence is low, it can pose management problems. The definition, diagnosis and classification of osteon...
Source: Medicina Oral, Patologia Oral y Cirugia Bucal - Category: ENT & OMF Tags: Med Oral Patol Oral Cir Bucal Source Type: research
Authors: Brown-Glaberman U, Stopeck AT Abstract Cancer therapy-induced bone loss (CTIBL) is a form of secondary osteoporosis associated with systemic chemotherapy and hormonal ablation therapy. The monitoring and treatment of CTIBL is an important component of comprehensive cancer care, especially for patients with curable disease and long life expectancies. Whereas oral bisphosphonates remain the most commonly used therapeutic option for CTIBL, additional treatment options may be required for patients who do not respond adequately or are intolerant to bisphosphonates, have renal insufficiency, or are receiving tre...
Source: Clinical Pharmacology: Advances and Applications - Category: Allergy & Immunology Tags: Clin Pharmacol Source Type: research
Background: Luteinising Hormone Releasing Hormone agonists (LHRHa) are used widely to treat PC. Transdermal oestrogen is an alternative, producing castrate levels of testosterone (T) but avoiding oestrogen-dependent LHRHa-associated toxicities particularly osteoporosis. Transdermal administration also bypasses first-pass hepatic metabolism and therefore should avoid the vascular toxicity of oral oestrogen.
Source: Maturitas - Category: Primary Care Authors: Tags: P179 Source Type: research
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