2020
OR29-01 Long-Term Safety in Adults with X-Linked Hypophosphatemia (XLH) Treated with Burosumab, a Fully Human Monoclonal Antibody Against FGF23: Final Results of a Phase 3 Trial
Perwad F, Portale A, Carpenter T, Briot K, Imel E, Kamenicky P, Weber T, Pitukcheewanont P, Cheong H, De Beur S, Imanishi Y, Ito N, Lachmann R, Tanaka H, Zhang L, Skrinar A, Rees L, Insogna K. OR29-01 Long-Term Safety in Adults with X-Linked Hypophosphatemia (XLH) Treated with Burosumab, a Fully Human Monoclonal Antibody Against FGF23: Final Results of a Phase 3 Trial. Journal Of The Endocrine Society 2020, 4: or29-01. PMCID: PMC7209551, DOI: 10.1210/jendso/bvaa046.147.Peer-Reviewed Original ResearchYears of ageSerum phosphorusWeek 96Dose reductionLong-term safety resultsTreatment-emergent adverse eventsMonoclonal antibodiesBaseline serum phosphorusHuman IgG1 monoclonal antibodyMean iPTH levelPhase 3 trialLong-term safetyHuman monoclonal antibodyConditional marketing authorizationMonths of ageIgG1 monoclonal antibodyIPTH levelsPlacebo groupAdverse eventsTreatment withdrawalWeek 24Radiographic evidenceMulticenter studyBurosumab treatmentMild hyperphosphatemia
2018
A Randomized, Double‐Blind, Placebo‐Controlled, Phase 3 Trial Evaluating the Efficacy of Burosumab, an Anti‐FGF23 Antibody, in Adults With X‐Linked Hypophosphatemia: Week 24 Primary Analysis
Insogna KL, Briot K, Imel EA, Kamenický P, Ruppe MD, Portale AA, Weber T, Pitukcheewanont P, Cheong HI, de Beur S, Imanishi Y, Ito N, Lachmann RH, Tanaka H, Perwad F, Zhang L, Chen C, Theodore‐Oklota C, Mealiffe M, San Martin J, Carpenter TO, Investigators O. A Randomized, Double‐Blind, Placebo‐Controlled, Phase 3 Trial Evaluating the Efficacy of Burosumab, an Anti‐FGF23 Antibody, in Adults With X‐Linked Hypophosphatemia: Week 24 Primary Analysis. Journal Of Bone And Mineral Research 2018, 33: 1383-1393. PMID: 29947083, DOI: 10.1002/jbmr.3475.Peer-Reviewed Original ResearchConceptsTreatment-related serious adverse eventsMean serum phosphate concentrationWOMAC physical function subscaleFibroblast growth factor 23Intact parathyroid hormoneSerious adverse eventsPhase 3 trialPhysical function subscaleChronic musculoskeletal painGrowth factor 23Serum phosphate concentrationRenal phosphate wastingHuman monoclonal antibodyLower limb deformitiesImportant medical needStiffness subscalePlacebo groupUrine calciumWorst painAdverse eventsWeek 24Dental abscessMusculoskeletal painFactor 23Function subscaleAssociations among circulating colony-stimulating factor-1, estrogen, and bone mineral density in postmenopausal women
Haas AV, Cong E, Simpson CA, Sukumar N, Deng Y, Insogna KL. Associations among circulating colony-stimulating factor-1, estrogen, and bone mineral density in postmenopausal women. Menopause The Journal Of The North American Menopause Society 2018, 25: 197-201. PMID: 28816930, DOI: 10.1097/gme.0000000000000974.Peer-Reviewed Original ResearchConceptsBone mineral densityEstrogen-deficient womenMineral densityBone lossColony-stimulating factor-1Kronos Early Estrogen Prevention StudyPostmenopausal bone lossPlacebo-controlled studyOsteoclastic bone resorptionFactor 1CSF-1 levelsCSF-1Estrogen replacementEstrogen therapyPlacebo groupPostmenopausal womenCardiovascular endpointsSerum levelsFemoral neckBone resorptionPrevention StudyAncillary studiesTreatment groupsWomenSignificant correlation
2016
Pioglitazone and Risk for Bone Fracture: Safety Data From a Randomized Clinical Trial
Viscoli CM, Inzucchi SE, Young LH, Insogna KL, Conwit R, Furie KL, Gorman M, Kelly MA, Lovejoy AM, Kernan WN, Investigators F. Pioglitazone and Risk for Bone Fracture: Safety Data From a Randomized Clinical Trial. The Journal Of Clinical Endocrinology & Metabolism 2016, 102: 914-922. PMID: 27935736, PMCID: PMC5460686, DOI: 10.1210/jc.2016-3237.Peer-Reviewed Original ResearchConceptsTransient ischemic attackIschemic strokeFracture riskBone fracturesRisk/benefit ratioAbsolute fracture riskInsulin Resistance InterventionPlacebo-treated patientsIschemic attackNondiabetic patientsPlacebo groupCardiovascular riskBone healthStroke trialsNondiabetic participantsPrevent fallsClinical trialsRelative riskSafety dataFracture classificationQuarterly interviewsPioglitazonePatientsResistance InterventionRisk increment
2010
Inhibiting gastric acid production does not affect intestinal calcium absorption in young, healthy individuals: A randomized, crossover, controlled clinical trial
Wright MJ, Sullivan RR, Gaffney‐Stomberg E, Caseria DM, O'Brien KO, Proctor DD, Simpson CA, Kerstetter JE, Insogna KL. Inhibiting gastric acid production does not affect intestinal calcium absorption in young, healthy individuals: A randomized, crossover, controlled clinical trial. Journal Of Bone And Mineral Research 2010, 25: 2205-2211. PMID: 20499372, PMCID: PMC3312746, DOI: 10.1002/jbmr.108.Peer-Reviewed Original ResearchConceptsIntestinal calcium absorptionProton pump inhibitorsCalcium absorptionGastric acidDual-stable calcium isotopesYoung adultsChronic PPI therapyPotent gastric acidGastric acid suppressionNegative calcium balanceGastric acid productionHealthy young adultsPPI esomeprazolePPI therapyPlacebo groupUrinary calciumAcid suppressionCrossover studyBone lossPump inhibitorsClinical trialsIntervention periodAcute effectsCalcium balanceHealthy individuals