- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Review, Journal: Dental care for patients taking antiresorptive drugs: a literature review. (Pubmed Central) - Dec 8, 2019 Antiresorptive drugs (ARDs), such as bisphosphonates or denosumab, that prevent bone resorption are widely used in patients with osteoporosis or with cancer that has metastasized to the bones...However, many dentists tend to hesitate to provide dental care to patients with ONJ, or tend to think that it is a problem to be dealt with by oral surgeons. This review gives an overview of ARD-related ONJ and provides the guidelines for dental care in patients taking ARDs to lower the risk of developing ONJ.
- |||||||||| Prolia (denosumab) / Amgen
Enrollment change, Trial withdrawal: Denosumab for Glucocorticoid-treated Children With Rheumatic Disorders (clinicaltrials.gov) - Dec 6, 2019 P1/2, N=0, Withdrawn, This review gives an overview of ARD-related ONJ and provides the guidelines for dental care in patients taking ARDs to lower the risk of developing ONJ. N=24 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Evomate (raloxifene hydrochloride) / Shreya Life Sciences
Journal: Osteoporosis: long-term treatment versus drug holiday-what is the evidence? (Pubmed Central) - Dec 5, 2019 The occurrence of multiple vertebral fractures after discontinuation of denosumab in the treatment of osteoporosis has reopened the debate on the optimal treatment duration and drug holidays.In principle, there is a difference in this regard between the discontinuation of medications such as bisphosphonates and substances without bone retention such as selective estrogen receptor modulators (SERMs), denosumab or teriparatide...Even after cessation of the SERM raloxifene, a decline in bone density can be observed, as with the termination of teriparatide...Beyond these special clinical situations, however, osteoporosis needs to be addressed as a chronic disease with a permanently increased fracture risk and the indication for therapy should be evaluated according to the extent of the risk of fracture.What happens after discontinuation of anti-osteoporosis drugs? The various effects on bone turnover markers, bone mineral density and fracture incidence of the individual drug groups are presented in detail, as are the resulting recommendations of the task forces of the American Society of Bone and Mineral Research (ASBMR) and the European Calcified Tissue Society (ECTS).
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas, Prolia (denosumab) / Amgen
Enrollment change, Trial suspension, Combination therapy: DICE: Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases. (clinicaltrials.gov) - Dec 5, 2019 P2, N=7, Suspended, The various effects on bone turnover markers, bone mineral density and fracture incidence of the individual drug groups are presented in detail, as are the resulting recommendations of the task forces of the American Society of Bone and Mineral Research (ASBMR) and the European Calcified Tissue Society (ECTS). N=88 --> 7 | Recruiting --> Suspended
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Benlysta (belimumab) / GSK, methotrexate / Generic Mfg.
Clinical, Journal: Stress fractures in systemic lupus erythematosus after long-term MTX use successfully treated by MTX discontinuation and individualized bone-specific therapy. (Pubmed Central) - Dec 2, 2019 We report the case of a 64-year-old woman with systemic lupus erythematosus (SLE) and recurrent bilateral stress fractures of the calcaneus due to long-term methotrexate (MTX) use...After years of unsuccessful treatment with bisphosphonates, a combined bone-specific denosumab-teriparatide treatment was initiated, and additional belimumab treatment was started to avoid intermittent steroid usage...Furthermore, the bone density and microarchitecture markedly improved. In conclusion, this case demonstrates that MTX discontinuation/replacement in combination with an individualized and state-of-the-art bone-specific therapy is effective in SLE patients with stress fractures after long-term MTX use.
- |||||||||| Sutent (sunitinib) / Pfizer
Retrospective data, Review, Journal: Osteonecrosis of the jaws produced by sunitinib: a systematic review. (Pubmed Central) - Nov 29, 2019 It is necessary that dentists, oral and maxillofacial surgeons as well as oncologists know the risk of ONJ that these antiresorptive drugs could have. There is a need to continue researching in this field with the aim of an increasing knowledge in this area and creating an adequate protocol of action for this population.
- |||||||||| Prolia (denosumab) / Amgen
Trial primary completion date, Metastases: SPLENDOUR: Survival imProvement in Lung cancEr iNduced by DenOsUmab theRapy (clinicaltrials.gov) - Nov 29, 2019 P3, N=514, Active, not recruiting, There is a need to continue researching in this field with the aim of an increasing knowledge in this area and creating an adequate protocol of action for this population. Trial primary completion date: Sep 2019 --> Jan 2020
- |||||||||| dexamethasone / generics
Journal: Intractable hypercalcaemia during pregnancy and the postpartum secondary to pathogenic variants in CYP24A1. (Pubmed Central) - Nov 22, 2019 Her symptoms partially responded to i.v. saline and corticosteroids in the short term but bisphosphonates such as Pamidronate and Zoledronic acid did not result in sustained improvement...Therapeutic alternatives are limited in pregnancy and their effectiveness is short-lived and mostly ineffective. Denosumab used in both our patients after delivery was the most effective agent normalizing calcium and may have benefit as a long-term therapeutic agent in preventing complications in patients with CYP24A1 deficiency.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Clinical, Journal: Optimizing antiresorptive treatment in patients with bone metastases: time to initiation, switching strategies, and treatment duration. (Pubmed Central) - Nov 22, 2019 Denosumab used in both our patients after delivery was the most effective agent normalizing calcium and may have benefit as a long-term therapeutic agent in preventing complications in patients with CYP24A1 deficiency. Our hypothesis-generating results support a more individualized approach on antiresorptive treatment including the lack of detrimental effect when the treatment is delayed, the potential benefit of switching strategy after skeletal disease progression or SSE, and the benefit of continuing antiresorptive treatment beyond 2 years.
- |||||||||| Prolia (denosumab) / Amgen
Biomarker, Trial termination: Denosumab for Breast Cancer With Bone Mets (clinicaltrials.gov) - Nov 22, 2019 P2, N=7, Terminated, Our hypothesis-generating results support a more individualized approach on antiresorptive treatment including the lack of detrimental effect when the treatment is delayed, the potential benefit of switching strategy after skeletal disease progression or SSE, and the benefit of continuing antiresorptive treatment beyond 2 years. Completed --> Terminated
- |||||||||| Prolia (denosumab) / Amgen
Enrollment open, Trial primary completion date: Reduced Dose-density of Denosumab for Unresectable GCTB (clinicaltrials.gov) - Nov 20, 2019 P2, N=100, Recruiting, The characteristics and progression of MRONJ in patients who take denosumab are reviewed, and therapeutic measures are discussed. Not yet recruiting --> Recruiting | Trial primary completion date: Jan 2024 --> Sep 2024
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: Present day controversies and consensus in curettage for giant cell tumor of bone. (Pubmed Central) - Nov 20, 2019 Treatment with denosumab did not decrease the local recurrence rate in patients who had been treated with curettage...Local recurrent tumors can be treated with curettage to keep the re-recurrence rate within an acceptable limit. The choice for how to treat GCTB in the proximal femur or distal radius requires special attention.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Review, Journal: Axial giant cell tumor - current standard of practice. (Pubmed Central) - Nov 20, 2019 Though the present data support the use of denosumab for effective management of these lesions but there is varied consensus on dosage and duration of treatment. This review article summarizes the basic features and treatment modalities related to axial GCTB stressing on multidisciplinary approach to achieve optimum outcomes.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Journal: Integrative modeling of drug therapy and the bone turnover. (Pubmed Central) - Nov 19, 2019 From our analysis, we have concluded that denosumab suppresses osteoclast differentiation, that results in reduced bone resorption. These results are in agreement with the experimental findings.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Safety and tolerance of denosumab in HIV patients (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_1737; Treatment with denosumab is safe and well tolerated in HIV patients in our sample. We need more studies to confirm the safety of denosumab in our patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Safety and tolerance of denosumab in HIV patients (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_927; Treatment with denosumab is safe and well tolerated in HIV patients in our sample. We need more studies to confirm the safety of denosumab in our patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
Safety and tolerance of denosumab in HIV patients (Exhibition hall) - Nov 15, 2019 - Abstract #EACS2019EACS_234; Treatment with denosumab is safe and well tolerated in HIV patients in our sample. We need more studies to confirm the safety of denosumab in our patients.
- |||||||||| Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK, Tamoxis (tamoxifen) / Bioprofarma
Clinical, Journal: Assessment and management of bone health in women with oestrogen receptor-positive breast cancer receiving endocrine therapy: Position statement of the Endocrine Society of Australia, the Australian and New Zealand Bone & Mineral Society, the Australasian Menopause Society and the Clinical Oncology Society of Australia. (Pubmed Central) - Nov 11, 2019 Before and during endocrine therapy, skeletal health should be assessed regularly, optimised by nonpharmacological intervention and where indicated antiresorptive treatment, in an individualised, multidisciplinary approach. Clinical trials are needed to better delineate long-term fracture risks of adjuvant endocrine therapy, and to determine the efficacy of interventions designed to minimise these risks.
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