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- || Review, Journal: Bisphosphonates for osteoporosis in people with cystic fibrosis. (Pubmed Central) - Jan 11, 2023
Additional trials are needed to determine if bone pain is more common or severe (or both) with the more potent zoledronate and if corticosteroids can ameliorate or prevent these adverse events. Future trials should also assess gastrointestinal adverse effects associated with oral bisphosphonates.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost Effectiveness of Denosumab for Secondary Prevention of Osteoporotic Fractures Among Postmenopausal Women in China: An Individual-Level Simulation Analysis. (Pubmed Central) - Jan 11, 2023
Denosumab is not cost effective for preventing secondary fractures among overall postmenopausal women in China. It is advisable to identify alternative denosumab regimens for high-risk subgroups among previously fractured postmenopausal women.
- | zoledronic acid / Generic mfg., alendronate / Generic mfg.
Retrospective data, Journal: Risk factors for new vertebral compression fracture after kyphoplasty and efficacy of osteoporosis treatment: A STROBE-compliant retrospective study. (Pubmed Central) - Jan 11, 2023
This study showed that for patients with new VCFs after KP, lower BMD, greater intradiscal cement leakage, greater KA recovery rate, and lower baseline vertebral height were likely risk factors for the development of new VCFs. Additionally, among the drugs used for the treatment of osteoporosis after KP, zoledronate tends to reduce the development of new VCFs compared with other bisphosphonates, SERMs, or calcium.
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Review, Journal: The clinical effectiveness of denosumab (Prolia®) in patients with hormone-sensitive cancer receiving endocrine therapy, compared to bisphosphonates, selective estrogen receptor modulators (SERM), and placebo: a systematic review and network meta-analysis. (Pubmed Central) - Jan 10, 2023
In MPC on HAT, denosumab (relative to placebo) was effective at preventing vertebral fractures and improving BMD at the FN and LS. Moreover, in WBC on AAIT, denosumab (relative to placebo) improved BMD at the FN, LS, TH, and TRO, as well as prevent vertebral fracture.
- | Livalo (pitavastatin) / Kowa, Eli Lilly
Preclinical, Journal: The Antineoplastic Effect of Carboplatin Is Potentiated by Combination with Pitavastatin or Metformin in a Chemoresistant High-Grade Serous Carcinoma Cell Line. (Pubmed Central) - Jan 9, 2023
Concerning HOSE6.3 cells, combining Carboplatin with almost all the repurposed drugs demonstrated a safe pharmacological profile. Overall, we propose that Pitavastatin or Metformin could act synergistically in combination with Carboplatin for the management of high-grade serous carcinoma patients with a Carboplatin plus Paclitaxel resistance profile.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Journal, Metastases: Breast Cancer Exosomal microRNAs Facilitate Pre-Metastatic Niche Formation in the Bone: A Mathematical Model. (Pubmed Central) - Jan 7, 2023
We next demonstrate how breast cancer exosomal miRNAs disrupt this balance, either by increasing or by decreasing the ratio of osteoclasts/osteoblasts, which results in abnormal high bone resorption or abnormal high bone forming, respectively, and in bone weakening in both cases. Finally we consider the case of abnormally high resorption and evaluate the effect of drugs, which may increase bone density to normal level, thus protecting the bone from invasion by cancer cells.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Retrospective data, Journal: Bone loss after denosumab discontinuation is prevented by alendronate and zoledronic acid but not risedronate: a retrospective study. (Pubmed Central) - Jan 6, 2023
Finally we consider the case of abnormally high resorption and evaluate the effect of drugs, which may increase bone density to normal level, thus protecting the bone from invasion by cancer cells. Subsequent treatment with ALN or ZOL but not NT and RIS mitigates BMD loss after Dmab discontinuation.
- | alendronate / Generic mfg., cinacalcet HCl / Generic mfg.
Trial completion: Renal Osteodystrophy: An Individual Management Approach (clinicaltrials.gov) - Jan 5, 2023
P=N/A, N=141, Completed, Sponsor: Hartmut Malluche, MD
Subsequent treatment with ALN or ZOL but not NT and RIS mitigates BMD loss after Dmab discontinuation. Active, not recruiting --> Completed
- A REAL-WORLD DISPROPORTIONALITY ANALYSIS OF ATRIAL FIBRILLATION ADVERSE EVENTS ASSOCIATED WITH BISPHOSPHONATES (Poster Hall_Hall F) - Jan 4, 2023 - Abstract #ACCWCC2023ACC_WCC_69;
We interrogated the Food and Drug Administration Adverse Event Reporting System (FAERS) database for reports of AF for zoledronate, alendronate, ibandronate, pamidronate, risedronate, etidronate, and tiludronate. AF reporting was disproportionately higher with most bisphosphonates except tiludronate.
- | alendronate / Generic mfg.
Journal: Fabrication, assessment, and optimization of alendronate sodium nanoemulsion-based injectable in-situ gel formulation for management of osteoporosis. (Pubmed Central) - Jan 3, 2023
In comparison with the ALS solution-loaded in-situ gel, the newly created optimal ALS-NE-loaded PPSG produced the sustained and regulated release of ALS; hence, a higher percentage of ALS remained in rats' muscles after 30 days. PPSG that has been loaded with an ALS-NE may therefore be a more auspicious, productive, and effective platform for osteoporosis treatment than conventional oral forms.
- ||| alendronate / Generic mfg.
New year's resolution using AI and your Twitter account . I have a lot of work to do this year... @AndreFernandes2 @oncohoegl @DRonaldcastillo @Bhandoria @unquinterio @IGCSociety @Zulay_Moreno (Twitter) - Jan 2, 2023
- | alendronate / Generic mfg.
Retrospective data, Journal: Effect of Abaloparatide on Bone Microarchitecture Assessed by Trabecular Bone Score in Women with Osteoporosis: Post Hoc Analysis of ACTIVE and ACTIVExtend. (Pubmed Central) - Jan 2, 2023
Women with osteoporosis randomized to abaloparatide or placebo for 18 months (ACTIVE), followed by alendronate for 24 months (ACTIVExtend), with evaluable TBS, were included in this post hoc analysis (N=911)...TBS increase was associated with vertebral fracture risk reduction. Microarchitectural improvement may be one mechanism by which abaloparatide strengthens vertebral bone.
- || simvastatin / Generic mfg., alendronate / Generic mfg.
Clinical, Journal: Comparison of simvastatin 1.2% gel and alendronate 1% gel in chronic periodontitis as local drug delivery: A randomized clinical trial. (Pubmed Central) - Dec 31, 2022
Test site 2 showed more percentage bone fill than test site 1. Usage of both SMV and ALN gels in periodontal intra bony defects can lead to significant improvements in clinical and radiographic parameters; however, ALN showed better osseous defect fill.
- || alendronate / Generic mfg.
Felicidades y sin duda esta década será magnífica y marvillosa y especial como las otras! (Twitter) - Dec 27, 2022
- The development of a hollow three-dimensional kidney spheroid model for the study of calcium-containing crystal formation (Yellow Area, Brown 3) - Dec 27, 2022 - Abstract #EAU2023EAU_1022;
- | alendronate / Generic mfg.
Preclinical, Journal: In vivo study of bovine hydroxyapatite-gelatin-hydroxypropyl methylcellulose with alendronate as injectable bone substitute composite in osteoporotic animal model. (Pubmed Central) - Dec 27, 2022
The BHA-Gel-HPMC-Ale IBS has the potential to reverse osteoporosis. Nevertheless, the underlying potential of these biomaterials to reverse osteoporosis needs further research.
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
New trial: Denosumab vs Alendronate After Vertebroplasty (clinicaltrials.gov) - Dec 22, 2022
P=N/A, N=90, Recruiting, Sponsor: Shenzhen People's Hospital
- | alendronate / Generic mfg.
Enrollment open: 64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy (clinicaltrials.gov) - Dec 15, 2022
P1, N=6, Recruiting, Sponsor: City of Hope Medical Center
Nevertheless, the underlying potential of these biomaterials to reverse osteoporosis needs further research. Suspended --> Recruiting
- | Recalbon (minodronic acid) / Ono Pharma
New P4 trial: Efficacy and Safety of Minodronate in Patients With Low Back Pain (clinicaltrials.gov) - Dec 9, 2022
P4, N=72, Not yet recruiting, Sponsor: Peking University Third Hospital
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date, Trial primary completion date: BAD: Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation (clinicaltrials.gov) - Nov 10, 2022
P=N/A, N=100, Recruiting, Sponsor: 251 Hellenic Air Force & VA General Hospital
Suspended --> Recruiting Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2022 --> Oct 2023
- | Prolia (denosumab) / Amgen
New trial: EURODEC: Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study) (clinicaltrials.gov) - Oct 12, 2022
P=N/A, N=125, Not yet recruiting, Sponsor: 424 General Military Hospital
- | alendronate / Generic mfg.
New P4 trial: A Single-blind RCT to Investigate the Effect of Alendronate on Knee Function Following ACLR (clinicaltrials.gov) - Sep 2, 2022
P4, N=64, Not yet recruiting, Sponsor: Chinese University of Hong Kong
- | alendronate / Generic mfg.
Enrollment change, Trial termination: Testosterone and Alendronate in Hypogonadal Men (clinicaltrials.gov) - Aug 18, 2022
P2, N=44, Terminated, Sponsor: Massachusetts General Hospital
Trial completion date: Oct 2023 --> Oct 2024 | Trial primary completion date: Oct 2022 --> Oct 2023 N=100 --> 44 | Suspended --> Terminated
- alendronate / Generic mfg.
Dual-Targeted NIRF Molecular Imaging Combined With Intravascular OCT for Inflammatory Micro-Calcification in the High-Risk Plaque (Zone 1, Science and Technology Hall, Level 3; Poster Board no. 1012) - Aug 11, 2022 - Abstract #AHA2022AHA_5241;
Our intravascular OCT/dual-NIRF imaging was feasible to simultaneously visualize micro-calcification, osteogenic activity and macrophages in the coronary-sized atheroma. This novel imaging strategy is expected to expand our pathophysiologic insight for the biological behavior of calcifying inflammatory activity existing on the superficial fibrous cap portion of high-risk plaques.
- | Prolia (denosumab) / Amgen
New P4 trial: OsteoNAFLD: Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease (clinicaltrials.gov) - Aug 9, 2022
P4, N=70, Not yet recruiting, Sponsor: Aristotle University Of Thessaloniki
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Enrollment closed, Trial completion date, Trial primary completion date: Comparative Antiresorptive Efficacy Discontinuation of Denosumab (clinicaltrials.gov) - Jun 8, 2022
P4, N=51, Active, not recruiting, Sponsor: Massachusetts General Hospital
This novel imaging strategy is expected to expand our pathophysiologic insight for the biological behavior of calcifying inflammatory activity existing on the superficial fibrous cap portion of high-risk plaques. Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Aug 2023 | Trial primary completion date: Aug 2024 --> Feb 2023
- ||||| narlumosbart (JMT103) / CSPC Pharma
New P2 trial: Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis (clinicaltrials.gov) - May 31, 2022
P2, N=231, Not yet recruiting, Sponsor: Shanghai JMT-Bio Inc.
- | alendronate / Generic mfg.
Enrollment change, Trial termination: APART: Alendronate for Prevention of AntiRetroviral Therapy-associated Bone Loss (clinicaltrials.gov) - May 26, 2022
P4, N=53, Terminated, Sponsor: University College Dublin
Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Aug 2023 | Trial primary completion date: Aug 2024 --> Feb 2023 N=80 --> 53 | Recruiting --> Terminated; Due to the COVID-19 pandemic the study was terminated prematurely
- | alendronate / Generic mfg.
New P4 trial: Phase IV Clinical Trial to Evaluate Efficacy and Safety of MASI BONE S (Alendronate Sodium Trihydrate) in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - May 24, 2022
P4, N=170, Recruiting, Sponsor: Yonsei University
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
New trial: Post-fracture Medication and Mortality (clinicaltrials.gov) - May 9, 2022
P=N/A, N=216155, Completed, Sponsor: National Cheng-Kung University Hospital
- | alendronate / Generic mfg.
Enrollment open: RadBone: Bone Toxicity Following Pelvic Radiotherapy (clinicaltrials.gov) - May 6, 2022
P=N/A, N=80, Recruiting, Sponsor: The Christie NHS Foundation Trust
N=80 --> 53 | Recruiting --> Terminated; Due to the COVID-19 pandemic the study was terminated prematurely Not yet recruiting --> Recruiting
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion, Trial completion date: The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover (clinicaltrials.gov) - Apr 22, 2022
P2, N=30, Completed, Sponsor: University Hospital, Ghent
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Sep 2022 --> Mar 2022
- ||| alendronate / Generic mfg.
Enrollment open: A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis (clinicaltrials.gov) - Apr 22, 2022
P4, N=60, Recruiting, Sponsor: Peking Union Medical College Hospital
Recruiting --> Completed | Trial completion date: Sep 2022 --> Mar 2022 Not yet recruiting --> Recruiting
- | alendronate / Generic mfg.
New P4 trial, Head-to-Head: The Effect of Effervescent Alendronate on Bone Turnover (clinicaltrials.gov) - Apr 12, 2022
P4, N=64, Active, not recruiting, Sponsor: Aarhus University Hospital
- |||||||||| Recalbon (minodronic acid) / Ono Pharma
New P3 trial: A Phase III Clinical Study of Minodronate Tablets in Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - Mar 31, 2022
P3, N=330, Not yet recruiting, Sponsor: Shandong New Time Pharmaceutical Co., LTD
- || Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial primary completion date: Denosumab Safety Assessment in Multiple Observational Databases (clinicaltrials.gov) - Mar 8, 2022
P=N/A, N=508215, Active, not recruiting, Sponsor: Amgen
Not yet recruiting --> Recruiting Trial primary completion date: Mar 2024 --> Jun 2023
- | Evenity (romosozumab) / Astellas, Amgen, UCB
Trial completion date, Trial primary completion date: Romosozumab in Women With Chronic SCI (clinicaltrials.gov) - Jan 5, 2022
P2, N=12, Recruiting, Sponsor: Northwestern University
Trial primary completion date: Mar 2024 --> Jun 2023 Trial completion date: Apr 2024 --> Feb 2025 | Trial primary completion date: Mar 2023 --> Sep 2024
- | alendronate / Generic mfg.
New P1 trial: Effect of Sodium Alendronate on the Final Implant Stability. (clinicaltrials.gov) - Dec 16, 2021
P1, N=24, Recruiting, Sponsor: Cairo University
- | alendronate / Generic mfg.
New P4 trial: Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover (clinicaltrials.gov) - Dec 9, 2021
P4, N=60, Recruiting, Sponsor: Hartmut Malluche, MD
- ||||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment change: Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa (clinicaltrials.gov) - Nov 22, 2021
P3, N=30, Recruiting, Sponsor: Karen Klahr Miller, MD
Trial completion date: Apr 2024 --> Feb 2025 | Trial primary completion date: Mar 2023 --> Sep 2024 N=75 --> 30
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion, Trial completion date, Trial primary completion date: Alendronate Versus Denosumab in Kidney Transplant Patients (clinicaltrials.gov) - Nov 12, 2021
P2/3, N=90, Completed, Sponsor: Ain Shams University
N=75 --> 30 Active, not recruiting --> Completed | Trial completion date: Jan 2021 --> May 2021 | Trial primary completion date: Jan 2021 --> May 2021
- | alendronate / Generic mfg.
Trial primary completion date: ALOSTRA: Alendronate Treatment of Osteoporosis in Rheumatoid Arthritis (clinicaltrials.gov) - Nov 5, 2021
P2, N=69, Active, not recruiting, Sponsor: University of Aarhus
Active, not recruiting --> Completed | Trial completion date: Jan 2021 --> May 2021 | Trial primary completion date: Jan 2021 --> May 2021 Trial primary completion date: Jul 2021 --> Dec 2021
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
New P4 trial: The Optimal Sequential Therapy After Long Term Denosumab Treatment (clinicaltrials.gov) - Oct 25, 2021
P4, N=44, Recruiting, Sponsor: National Taiwan University Hospital
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
Trial completion date: BAD: Alendronate in an Weekly Effervescent Tablet Formulation Following Denosumab Discontinuation (clinicaltrials.gov) - Oct 22, 2021
P=N/A, N=100, Recruiting, Sponsor: 251 Hellenic Air Force & VA General Hospital
Trial primary completion date: Jul 2021 --> Dec 2021 Trial completion date: Apr 2023 --> Oct 2023
- | alendronate / Generic mfg.
Enrollment change: 99Tc-MDP in Postmenopausal Women With Differentiated Thyroid Cancer and Osteoporosis (clinicaltrials.gov) - Oct 18, 2021
P=N/A, N=142, Completed, Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Trial completion date: Apr 2023 --> Oct 2023 N=206 --> 142
- | alendronate / Generic mfg.
Trial completion: Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment (clinicaltrials.gov) - Sep 29, 2021
P4, N=140, Completed, Sponsor: Mahidol University
N=206 --> 142 Recruiting --> Completed
- |||| Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Enrollment open: Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa (clinicaltrials.gov) - Sep 24, 2021
P3, N=75, Recruiting, Sponsor: Karen Klahr Miller, MD
Recruiting --> Completed Not yet recruiting --> Recruiting
- Prolia (denosumab) / Amgen, Daiichi Sankyo
Phase classification: Effects of Denosumab on Bone Mineral Density in Women With Anorexia Nervosa: A Pilot Study (clinicaltrials.gov) - Sep 16, 2021
P3, N=30, Completed, Sponsor: Massachusetts General Hospital
Not yet recruiting --> Recruiting Phase classification: P1 --> P3
- | Evenity (romosozumab-aqqg) / Astellas, Amgen, UCB
Phase classification: Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa (clinicaltrials.gov) - Sep 16, 2021
P3, N=75, Not yet recruiting, Sponsor: Karen Klahr Miller, MD
Phase classification: P1 --> P3 Phase classification: P1 --> P3
- | Prolia (denosumab) / Amgen, Daiichi Sankyo
New trial: Comparative Persistence With Prolia and Weekly Alendronate in 5 Asia-Pacific countries: a Prospective Observational Study. (EUDRACT) - Sep 9, 2021
P, N=770, Recruiting, Sponsor: Amgen Inc.