Availability of synthetic salmon calcitonin in tissue fluid after a single intravenous dose

Concia, Ercole; Cruciani, Mario; Bartucci, F.; Arrigoni, Louis; Longoni, A.

doi:10.1007/bf00194408

Cited by 2 publications

(1 citation statement)

References 10 publications

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“…3). The pharmacokinetic parameters evaluated after the intravenous infusion are in fair agreement with values published earlier (32)(33)(34)(35)(36) ; the shorter half-life and higher systemic clearance found here probably can be explained by progress in the determination methods, with increased specificity resulting in lower signal from cross-reactive metabolites. The lower terminal half-life values observed after oral administration, compared with those after intravenous infusion, suggest a slight slow-release effect of the oral formulation.…”

Section: Discussionsupporting

confidence: 91%

Bioavailability and Biological Efficacy of a New Oral Formulation of Salmon Calcitonin in Healthy Volunteers

Buclin¹,

Rochat²,

Burckhardt³

et al. 2002

Journal of Bone and Mineral Research

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Salmon calcitonin (SCT) is a well-tolerated peptide drug with a wide therapeutic margin and is administered parenterally for long-term treatments of bone diseases. Its clinical usefulness would be enhanced by the development of an orally active formulation. In this randomized crossover double-blinded phase I trial, controlled by both a placebo and a parenteral verum, we have tested a new oral formulation of SCT associated with a caprylic acid derivative as carrier. Eight healthy volunteers received single doses of 400, 800, and 1200 g of SCT orally, a placebo, and a 10-g (50 IU) SCT intravenous infusion. SCT was reliably absorbed from the oral formulation, with an absolute bioavailability of 0.5-1.4%, depending on the dose. It induced a marked, dose-dependent drop in blood and urine C-terminal telopeptide of type I collagen (CTX), a sensitive and specific bone resorption marker, with the effects of 1200 g exceeding those of 10 g intravenously. It also decreased blood calcium and phosphate, and increased the circulating levels of parathyroid hormone (PTH) and, transiently, the urinary excretion of calcium.

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Section: Discussionsupporting

confidence: 91%

Bioavailability and Biological Efficacy of a New Oral Formulation of Salmon Calcitonin in Healthy Volunteers

Buclin¹,

Rochat²,

Burckhardt³

et al. 2002

Journal of Bone and Mineral Research

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Intranasal Salcatonin (Salmon Calcitonin)

Plosker¹,

McTavish²

1996

Drugs & Aging

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Osteoporosis is a common problem among postmenopausal women and is associated with significant morbidity, mortality and costs primarily resulting from osteoporotic fractures. Salcatonin (salmon calcitonin) inhibits osteoclastic bone resorption and is approximately 40 to 50 times more potent than human calcitonin. In most randomised trials in which intranasal salcatonin (usually 50 to 200 IU/day plus oral calcium supplements) was administered for 1 to 5 years to postmenopausal women for prevention of osteoporosis, bone mineral density or content of the lumbar spine increased by approximately 1 to 3% from baseline. In contrast, postmenopausal women receiving only oral calcium supplements typically had reductions in bone mineral density or content of about 3 to 6%. The difference between treatment groups was statistically significant in essentially all studies. Although changes in bone mineral density or content were broadly similar in studies of postmenopausal women with established osteoporosis to those in postmenopausal women receiving therapy for prevention of the disease, studies in women with established osteoporosis did not usually demonstrate statistically significant differences between treatment groups. Also in postmenopausal women with established osteoporosis, intranasal salcatonin reduced pain and/or analgesic consumption in some trials and, in a limited number of studies of relatively short duration (i.e. < or = 2 years), the incidence of osteoporotic fractures. A large multicentre 5-year study with adequate statistical power to confirm the effect of intranasal salcatonin on reducing osteoporotic fracture rates in postmenopausal women is currently under way. The intranasal formulation of salcatonin offers a more convenient and better tolerated alternative to the parenteral formulation of the drug which is administered by regular subcutaneous or intramuscular injections. Adverse events associated with the intranasal formulation are generally mild and transient, usually involving local reactions such as nasal discomfort, rhinorrhoea or rhinitis. Thus, for postmenopausal women unable or unwilling to tolerate long term hormone replacement therapy, intranasal salcatonin is an attractive alternative for the management of osteoporosis.

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Availability of synthetic salmon calcitonin in tissue fluid after a single intravenous dose

Cited by 2 publications

References 10 publications

Bioavailability and Biological Efficacy of a New Oral Formulation of Salmon Calcitonin in Healthy Volunteers

Bioavailability and Biological Efficacy of a New Oral Formulation of Salmon Calcitonin in Healthy Volunteers

Intranasal Salcatonin (Salmon Calcitonin)

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