The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study

Osteoarthritis and Cartilage

Volumn 18, Issue 2, 2010, Pages 150-159

  Karsdal, M A ^a   Byrjalsen, I ^a   Henriksen, K ^a   Riis, B J ^a   Lau, E M ^b   Arnold, M ^c   Christiansen, C ^a  

^a NORDIC BIOSCIENCE A S   (Denmark)

^b Hong Kong Orthopaedic and Osteoporosis Center for Treatment and Research   (Hong Kong)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

5 CNAC; Bone resorption; Calcitonin; Cartilage degradation; Clinical trial; Oral; Osteoarthritis; Peptide

Indexed keywords

CARBOXY TERMINAL TELOPEPTIDE; DRUG CARRIER; N (5 CHLOROSALICYLOYL) 8 AMINOCAPRYLIC ACID; OSTEOCALCIN; PLACEBO; SALCATONIN; UNCLASSIFIED DRUG;

ADULT; AGE DISTRIBUTION; AGED; AREA UNDER THE CURVE; ARTICLE; BONE DEFECT; CARTILAGE DEGENERATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIET RESTRICTION; DOUBLE BLIND PROCEDURE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG URINE LEVEL; EVENING DOSAGE; FEMALE; FOLLOW UP; GASTROINTESTINAL TOXICITY; HUMAN; KNEE OSTEOARTHRITIS; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; OSTEOLYSIS; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SEX DIFFERENCE;

ADMINISTRATION, ORAL; AGED; AREA UNDER CURVE; BONE DENSITY CONSERVATION AGENTS; BONE RESORPTION; CALCITONIN; CARRIER PROTEINS; COLLAGEN TYPE II; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; OSTEOARTHRITIS; OSTEOCALCIN; OSTEOGENESIS; PEPTIDE FRAGMENTS; PROCOLLAGEN;

EID: 74149092299     PISSN: 10634584     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.joca.2009.08.004     Document Type: Article

References (52)

1. Abramson S.B., Attur M., and Yazici Y. Prospects for disease modification in osteoarthritis. Nat Clin Pract Rheumatol 2 (2006) 304-312
2. Karsdal M.A., Leeming D.J., Dam E.B., Henriksen K., Alexandersen P., Pastoureau P., et al. Should subchondral bone turnover be targeted when treating osteoarthritis?. Osteoarthritis Cartilage 16 (2008) 638-646
3. Pelletier JP, Martel-Pelletier J, Abramson SB. Osteoarthritis, an inflammatory disease: potential implication for the selection of new therapeutic targets. Arthritis Rheum 2001;44:1237-47.
4. Chambers T.J., and Moore A. The sensitivity of isolated osteoclasts to morphological transformation by calcitonin. J Clin Endocrinol Metab 57 (1983) 819-824
5. Nicholson G.C., Moseley J.M., Sexton P.M., Mendelsohn F.A., and Martin T.J. Abundant calcitonin receptors in isolated rat osteoclasts. Biochemical and autoradiographic characterization. J Clin Invest 78 (1986) 355-360
6. Murrills R.J., Shane E., Lindsay R., and Dempster D.W. Bone resorption by isolated human osteoclasts in vitro: effects of calcitonin. J Bone Miner Res 4 (1989) 259-268
7. Karsdal M.A., Henriksen K., Arnold M., and Christiansen C. Calcitonin: a drug of the past or for the future? Physiologic inhibition of bone resorption while sustaining osteoclast numbers improves bone quality. BioDrugs 22 (2008) 137-144
8. Chesnut III C.H., Silverman S., Andriano K., Genant H., Gimona A., Harris S., et al. A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. PROOF Study Group. Am J Med 109 (2000) 267-276
9. Tanko L.B., Bagger Y.Z., Alexandersen P., Devogelaer J.P., Reginster J.Y., Chick R., et al. Safety and efficacy of a novel salmon calcitonin (sCT) technology-based oral formulation in healthy postmenopausal women: acute and 3-month effects on biomarkers of bone turnover. J Bone Miner Res 19 (2004) 1531-1538
10. Bagger Y.Z., Tanko L.B., Alexandersen P., Karsdal M.A., Olson M., Mindeholm L., et al. Oral salmon calcitonin induced suppression of urinary collagen type II degradation in postmenopausal women: a new potential treatment of osteoarthritis. Bone 37 (2005) 425-430
11. Manicourt D.H., Azria M., Mindeholm L., Thonar E.J., and Devogelaer J.P. Oral salmon calcitonin reduces Lequesne's algofunctional index scores and decreases urinary and serum levels of biomarkers of joint metabolism in knee osteoarthritis. Arthritis Rheum 54 (2006) 3205-3211
12. Manicourt D.H., Devogelaer J.P., Azria M., and Silverman S. Rationale for the potential use of calcitonin in osteoarthritis. J Musculoskelet Neuronal Interact 5 (2005) 285-293
13. Van den M.G. Colon drug delivery. Expert Opin Drug Deliv 3 (2006) 111-125
14. Malkov D., Angelo R., Wang H.Z., Flanders E., Tang H., and Gomez-Orellana I. Oral delivery of insulin with the eligen technology: mechanistic studies. Curr Drug Deliv 2 (2005) 191-197
15. Mustata G., and Dinh S.M. Approaches to oral drug delivery for challenging molecules. Crit Rev Ther Drug Carrier Syst 23 (2006) 111-135
16. Mlynek G.M., Calvo L.J., and Robinson J.R. Carrier-enhanced human growth hormone absorption across isolated rabbit intestinal tissue. Int J Pharm 197 (2000) 13-21
17. Wu S.J., and Robinson J.R. Transcellular and lipophilic complex-enhanced intestinal absorption of human growth hormone. Pharm Res 16 (1999) 1266-1272
18. Schaller S., Henriksen K., Hoegh-Andersen P., Sondergaard B.C., Sumer E.U., Tanko L.B., et al. In vitro, ex vivo, and in vivo methodological approaches for studying therapeutic targets of osteoporosis and degenerative joint diseases: how biomarkers can assist?. Assay Drug Dev Technol 3 (2005) 553-580
19. Karsdal M.A., Henriksen K., Leeming D.J., Mitchell P., Duffin K., Barascuk N., et al. Biochemical markers and the FDA critical path: how biomarkers may contribute to the understanding of pathophysiology and provide unique and necessary tools for drug development. Biomarkers 14 (2009) 181-202
20. Saftig P., Hunziker E., Wehmeyer O., Jones S., Boyde A., Rommerskirch W., et al. Impaired osteoclastic bone resorption leads to osteopetrosis in cathepsin-K-deficient mice. Proc Natl Acad Sci U S A 95 (1998) 13453-13458
21. Schaller S., Henriksen K., Sveigaard C., Heegaard A.M., Helix N., Stahlhut M., et al. The chloride channel inhibitor n53736 prevents bone resorption in ovariectomized rats without changing bone formation. J Bone Miner Res 19 (2004) 1144-1153
22. Ravn P., Hosking D., Thompson D., Cizza G., Wasnich R.D., McClung M., et al. Monitoring of alendronate treatment and prediction of effect on bone mass by biochemical markers in the early postmenopausal intervention cohort study. J Clin Endocrinol Metab 84 (1999) 2363-2368
23. Sondergaard B.C., Henriksen K., Wulf H., Oestergaard S., Schurigt U., Brauer R., et al. Relative contribution of matrix metalloprotease and cysteine protease activities to cytokine-stimulated articular cartilage degradation. Osteoarthritis and Cartilage 14 (2006) 738-748
24. Nielsen R.H., Stoop R., Leeming D.J., Stolina M., Qvist P., Christiansen C., et al. Evaluation of cartilage damage by measuring collagen degradation products in joint extracts in a traumatic model of osteoarthritis. Biomarkers (2007) 1-9
25. Dam E.B., Byrjalsen I., Karsdal M.A., Qvist P., and Christiansen C. Increased urinary excretion of C-telopeptides of type II collagen (CTX-II) predicts cartilage loss over 21 months by MRI. Osteoarthritis Cartilage 17 (2008) 384-389
26. Meulenbelt I., Kloppenburg M., Kroon H.M., Houwing-Duistermaat J.J., Garnero P., Hellio-Le Graverand M.P., et al. Clusters of biochemical markers are associated with radiographic subtypes of osteoarthritis (OA) in subject with familial OA at multiple sites. The GARP study. Osteoarthritis Cartilage 15 (2007) 379-385
27. Meulenbelt I., Kloppenburg M., Kroon H.M., Houwing-Duistermaat J.J., Garnero P., Hellio-Le Graverand M.P., et al. Urinary CTX-II levels are associated with radiographic subtypes of osteoarthritis in hip, knee, hand, and facet joints in subject with familial osteoarthritis at multiple sites: the GARP study. Ann Rheum Dis 65 (2006) 360-365
28. Manicourt D.H., Azria M., Mindeholm L., and Devogelaer J.P. Efficacy of calcitonin therapy in patients with knee osteoarthritis: a clinical and biochemical preliminary study. Osteoarthritis Cartilage 13 (2005) s88
29. Karsdal M.A., Byrjalsen I., Riis B.J., Azria M., and Christiansen C. Influence of food intake on the bioavailability and efficacy of oral calcitonin. Br J Pharmacol (2009)
30. Karsdal M.A., Byrjalsen I., Riis B.J., and Christiansen C. Optimizing bioavailability of oral administration of small peptides through pharmacokinetic and pharmacodynamic parameters: the effect of water and timing of meal intake on oral delivery of salmon calcitonin. BMC Clin Pharmacol 8 (2008) 5
31. Karsdal M.A., Byrjalsen I., Riis B.J., and Christiansen C. Investigation of the diurnal variation in bone resorption for optimal drug delivery and efficacy in osteoporosis with oral calcitonin. BMC Clin Pharmacol 8 (2008) 12
32. Karsdal M.A., Byrjalsen I., Riis B.J., Henriksen K., and Christiansen C. A pharmacokinetic and pharmacodynamic comparison of synthetic and recombinant oral salmon calcitonin. J Clin Pharmacol (2009)
33. Heersche J.N. Calcitonin effects on osteoclastic resorption: the 'escape phenomenon' revisited. Bone Miner 16 (1992) 174-177
34. Mouritzen U., Christgau S., Lehmann H.J., Tanko L.B., and Christiansen C. Cartilage turnover assessed with a newly developed assay measuring collagen type II degradation products: influence of age, sex, menopause, hormone replacement therapy, and body mass index. Ann Rheum Dis 62 (2003) 332-336
35. Nielsen R.H., Christiansen C., Stolina M., and Karsdal M.A. Oestrogen exhibits type II collagen protective effects and attenuates collagen-induced arthritis in rats. Clin Exp Immunol 152 (2008) 21-27
36. Oestergaard S., Sondergaard B.C., Hoegh-Andersen P., Henriksen K., Qvist P., Christiansen C., et al. Effects of ovariectomy and estrogen therapy on type II collagen degradation and structural integrity of articular cartilage in rats: implications of the time of initiation. Arthritis Rheum 54 (2006) 2441-2451
37. Cirillo D.J., Wallace R.B., Wu L., and Yood R.A. Effect of hormone therapy on risk of hip and knee joint replacement in the Women's Health Initiative. Arthritis Rheum 54 (2006) 3194-3204
38. Spector T.D., Conaghan P.G., Buckland-Wright J.C., Garnero P., Cline G.A., Beary J.F., et al. Effect of risedronate on joint structure and symptoms of knee osteoarthritis: results of the BRISK randomized, controlled trial [ISRCTN01928173]. Arthritis Res Ther 7 (2005) R625-R633
39. Christgau S., Tanko L.B., Cloos P.A., Mouritzen U., Christiansen C., Delaisse J.M., et al. Suppression of elevated cartilage turnover in postmenopausal women and in ovariectomized rats by estrogen and a selective estrogen-receptor modulator (SERM). Menopause 11 (2004) 508-518
40. Karsdal M.A., Leeming D.J., Byrjalsen I., and Christiansen C. Tibolone inhibits bone resorption without secondary positive effects on cartilage degradation. BMC Musculoskelet Disord 9 (2008) 153
41. Karsdal M.A., Martin T.J., Bollerslev J., Christiansen C., and Henriksen K. Are nonresorbing osteoclasts sources of bone anabolic activity?. J Bone Miner Res 22 (2007) 487-494
42. Rogers J., Shepstone L., and Dieppe P. Is osteoarthritis a systemic disorder of bone?. Arthritis Rheum 50 (2004) 452-457
43. Lajeunesse D. The role of bone in the treatment of osteoarthritis. Osteoarthritis Cartilage 12 Suppl A (2004) S34-S38
44. Buckland-Wright C. Subchondral bone changes in hand and knee osteoarthritis detected by radiography. Osteoarthritis Cartilage 12 Suppl A (2004) S10-S19
45. Bailey A.J., Mansell J.P., Sims T.J., and Banse X. Biochemical and mechanical properties of subchondral bone in osteoarthritis. Biorheology 41 (2004) 349-358
46. Neilson M., White A., Malik U., Morrison E., McGill P.E., and McDonald S.W. Changes in bone architecture in the femoral head and neck in osteoarthritis. Clin Anat 17 (2004) 378-391
47. Karsdal M.A., Sondergaard B.C., Arnold M., and Christiansen C. Calcitonin affects both bone and cartilage: a dual action treatment for osteoarthritis?. Ann N Y Acad Sci 1117 (2007) 181-195
48. Sondergaard B.C., Ostergaard S., Christiansen C., and Karsdal M.A. The Effect of oral calcitonin on cartilage turnover and surface erosion in the ovariectomized rat model. Arthritis Rheum 2007 (2007) 2674-2678
49. Behets C., Williams J.M., Chappard D., Devogelaer J.P., and Manicourt D.H. Effects of calcitonin on subchondral trabecular bone changes and on osteoarthritic cartilage lesions after acute anterior cruciate ligament deficiency. J Bone Miner Res 19 (2004) 1821-1826
50. El Hajjaji H., Williams J.M., Devogelaer J.P., Lenz M.E., Thonar E.J., and Manicourt D.H. Treatment with calcitonin prevents the net loss of collagen, hyaluronan and proteoglycan aggregates from cartilage in the early stages of canine experimental osteoarthritis. Osteoarthritis Cartilage 12 (2004) 904-911
51. Manicourt D.H., Poilvache P., Van Egeren A., Devogelaer J.P., Lenz M.E., and Thonar E.J. Synovial fluid levels of tumor necrosis factor alpha and oncostatin M correlate with levels of markers of the degradation of crosslinked collagen and cartilage aggrecan in rheumatoid arthritis but not in osteoarthritis. Arthritis Rheum 43 (2000) 281-288
52. Manicourt D.H., Altman R.D., Williams J.M., Devogelaer J.P., Druetz-Van Egeren A., Lenz M.E., et al. Treatment with calcitonin suppresses the responses of bone, cartilage, and synovium in the early stages of canine experimental osteoarthritis and significantly reduces the severity of the cartilage lesions. Arthritis Rheum 42 (1999) 1159-1167