Oral delivery of proteins has been hampered by an array of difficulties. However, promising novel oral delivery systems have been developed. 5-CNAC, formulated with the peptide salmon calcitonin, is in phase III clinical trials for the treatment of osteoporosis or osteoarthritis and could become the...
April 5, 2011
Journal:
J Clin Pharmacol
Author:
Karsdal MA, Henriksen K, Bay-Jensen AC, Molloy B, Arnold M, John MR, Byrjalsen I, Azria M, Riis BJ, Qvist P, Christiansen C
BACKGROUND: Osteoarthritis (OA) involves changes in both bone and cartilage. These processes might be associated under some circumstances. This study investigated correlations between bone and cartilage degradation in patients with OA as a function of sex, Kellgren-Lawrence (KL) score, Body Mass Ind...
June 17, 2010
Journal:
BMC Musculoskelet Disord
Author:
Karsdal MA, Byrjalsen I, Bay-Jensen AC, Henriksen K, Riis BJ, Christiansen C
BACKGROUND: Proteolytic degradation of Type I Collagen by proteases may play an important role in remodeling of atherosclerotic plaques, contributing to increased risk of plaque rupture.The aim of the current study was to investigate whether human macrophage foam cells degrade the extracellular matr...
April 21, 2010
Journal:
BMC Cardiovasc Disord
Author:
Barascuk N, Skjøt-Arkil H, Register TC, Larsen L, Byrjalsen I, Christiansen C, Karsdal MA
Background: The aim of this study was to investigate the pharmacokinetic and pharmacodynamic parameters of oral salmon calcitonin (oSCT) administered over 14 days to men and women presenting with osteoarthritis (OA). Materials and methods: The study was a phase-I, 2-week, placebo-controlled, double...
February 18, 2010
Journal:
Osteoarthritis Cartilage
Author:
Karsdal MA, Byrjalsen I, Henriksen K, Riis BJ, Lau EM, Arnold M, Christiansen C
Aims: The aims of the study were to investigate interindividual variations in the bioavailability of salmon calcitonin (sCT) following single oral 0.8 mg doses at three different times of the day, and intraindividual variation in sCT bioavailability at each end of a 14-day treatment period. We also ...
January 16, 2010
Journal:
Eur J Clin Pharmacol
Author:
Karsdal MA, Byrjalsen I, Henriksen K, Riis BJ, Christiansen C
Background: Bone size (BS) variation is under strong genetic control and plays an important role in determining bone strength and fracture risk. Recently, a genome-wide association study identified polymorphisms associated with hip BS variation in the PLCL1 (phospholipase c-like 1) locus. Carriers o...
December 23, 2009
Journal:
BMC Med Genet.
Author:
Cauchi S, Byrjalsen I, Durand E, Karsdal MA, Froguel P
INTRODUCTION: At present, no disease-modifying osteoarthritis drugs (DMOADS) are approved by the FDA (US Food and Drug Administration); possibly partly due to inadequate trial design since efficacy demonstration requires disease progression in the placebo group. We investigated whether combinations ...
July 24, 2009
Journal:
Arthritis Res Ther
Author:
Dam EB, Loog M, Christiansen C, Byrjalsen I, Folkesson J, Nielsen M, Qazi AA, Pettersen PC, Garnero P, Karsdal MA
Aims: To investigate the influence of food intake on the bioavailability and pharmacodynamic effects of salmon calcitonin (sCT). Methods: A single-blind, randomized, partly placebo-controlled study was conducted in 36 healthy postmenopausal female volunteers aged 62-74 years. The influence of food ...
April 4, 2009
Journal:
Br J Clin Pharmacol
Author:
Karsdal MA, Byrjalsen I, Azria M, Arnold M, Choi L, Riis BJ, Christiansen C
Anti-resorptive strategies may affect bone collagen maturation differently depending on the mode of action. Orally administrated calcitonin resulted in a dose dependent inhibition of bone resorption but did not change bone collagen maturation. This may reflect aspects of bone quality. INTRODUCTION:...
September 19, 2008
Journal:
Osteoporos Int.
Author:
Karsdal MA, Byrjalsen I, Leeming DJ, Delmas PD, Christiansen C
Background: To investigate the influence of water intake and dose timing on the pharmacokinetic and pharmacodynamic parameters of an oral formulation of salmon calcitonin (sCT). Methods: The study was a randomized, partially-blind, placebo-controlled, single dose, exploratory crossover phase I stud...
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