Fortical (Calcitonin-Salmon Nasal) - Summary

FORTICAL SUMMARY

FORTICAL^®
calcitonin-salmon
(rDNA origin)
Nasal Spray

Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. The active ingredient in FORTICAL^® calcitonin-salmon (rDNA origin) Nasal Spray is a polypeptide of 32 amino acids manufactured by recombinant DNA technology and is identical to calcitonin-salmon produced by chemical synthesis.

Postmenopausal Osteoporosis – FORTICAL^® calcitonin-salmon (rDNA origin) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause with low bone mass relative to healthy premenopausal women. Use of FORTICAL^® calcitonin-salmon (rDNA origin) Nasal Spray is recommended in conjunction with an adequate calcium (at least 1000 mg elemental calcium per day) and Vitamin D (400 International Units per day) intake to retard the progressive loss of bone mass. The evidence of efficacy for calcitonin-salmon is based on increases in spinal bone mineral density (BMD) observed in clinical trials.

Two randomized, placebo-controlled trials were conducted in 325 postmenopausal women (227 treated with calcitonin-salmon nasal spray and 98 treated with placebo) with spinal, forearm or femoral BMD at least one standard deviation below the normal value for healthy premenopausal women. These studies conducted over two years demonstrated that 200 International Units daily of calcitonin-salmon nasal spray increases lumbar vertebral BMD relative to baseline and relative to placebo in osteoporotic women who were greater than 5 years postmenopause. Calcitonin-salmon nasal spray produced statistically significant increases in lumbar vertebral BMD compared to placebo as early as 6 months after initiation of therapy with persistence of this level for up to 2 years of observation.

No effects of calcitonin-salmon nasal spray on cortical bone of the forearm or hip were demonstrated. However, in one study, BMD of the hip showed a statistically significant increase compared with placebo in a region composed of predominantly trabecular bone after 1 year of treatment changing to a trend at 2 years that was no longer statistically significant.

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NEWS HIGHLIGHTS

Media Articles Related to Fortical (Calcitonin Nasal)

calcitonin, Fortical, Miacalcin
Source: MedicineNet Bone Density Scan Specialty [2009.03.12]
Title: calcitonin, Fortical, Miacalcin
Category: Medications
Created: 12/31/1997
Last Editorial Review: 3/12/2009

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Published Studies Related to Fortical (Calcitonin Nasal)

Influence of food intake on the bioavailability and efficacy of oral calcitonin. [2009.04]
AIMS: To investigate the influence of food intake on the bioavailability and pharmacodynamic effects of salmon calcitonin (sCT)... CONCLUSIONS: Postprandial dosing may limit the bioavailability of orally administered sCT. Maximal benefit can be achieved by dosing at least 10 min prior to meal time.

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. [2008.09.09]
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)... CONCLUSION: 0.8 mg sCT with 50 ml of water taken 30 and 60 minutes prior to meal time resulted in optimal pharmacodynamic and pharmacokinetic parameters. The data suggest that this novel oral formulation may have improved absorption and reduction of bone resorption compared to that of the nasal form.

The effects of oral calcitonin on bone collagen maturation: implications for bone turnover and quality. [2008.09]
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: The aim of the present study was to evaluate the effect of oral calcitonin on bone collagen maturation measured as the ratio between the degradation products of newly synthesized C-telopeptides of type I collagen (alphaalphaCTX) and mature isomerized betabetaCTX in postmenopausal women... CONCLUSIONS: Calcitonin dose-dependently and significantly reduced both alphaalphaCTX to betabetaCTX levels in urine without affecting the alphaalphaCTX to betabetaCTX ratio. This is in direct contrast to other anti-resorptive therapies, in which strong treatment-dependent effect on the endogenous age profile of bone has been observed. These data highlight that even though the treatments may have comparable effects on BMD, endogenous bone composition, which may be associated to bone quality, is strongly affected by the type of intervention, in which calcitonin display highly divergent effects from that of other anti-resorptives.

Salmon calcitonin in prevention of osteoporosis in maintenance dialysis patients. [2008.07.20]
BACKGROUND: Renal osteodystrophy is one of the commonest complications of chronic renal failure. It may have a severe impact on the quality of life of patients on maintenance dialysis therapy. Besides post-menopausal women and elderly people, the dialysis patients are another high risk group. But at present, there is no research on how to prevent osteoporosis in maintenance dialysis patients. This study was conducted to observe the bone density of maintenance dialysis patients and to evaluate the clinical outcomes and safety of different administration dosage of salmon calcitonin to prevent osteoporosis in maintenance dialysis patients... CONCLUSIONS: The dose of salmon calcitonin 50 U three times a week plus calcium carbonate and active vitamin D can effectively preserve the BMD and prevent bone loss in maintenance dialysis patients, and it is well tolerated by patients on maintenance dialysis.

A randomized double-blind placebo-controlled trial to investigate the effects of nasal calcitonin on bone microarchitecture measured by high-resolution peripheral quantitative computerized tomography in postmenopausal women - Study protocol. [2008.04.13]
ABSTRACT: BACKGROUND: Bone microarchitecture is a significant determinant of bone strength.We hypothezise that - compared to placebo - calcitonin impacts on microstructural parameters, with a possible difference between weight bearing and non-weight bearing bones.

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Clinical Trials Related to Fortical (Calcitonin Nasal)

Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women [Completed]
This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.

Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis [Completed]
The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0. 6 mg and 0. 8 mg oral calcitonin and 200 IU nasal calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0. 6 mg and 0. 8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.

Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women [Completed]
Calcitonin has been used for many years for treating osteoporosis in postmenopausal women, and it has been shown that calcitonin reduces pain after spine and hip fracture in women with osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture healing in postmenopausal women.

A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women [Recruiting]
The purpose of this study is to compare the effectiveness and tolerability of two medications, calcitonin nasal spray and a tablet containing calcitonin, in postmenopausal women with osteoporosis. Osteoporosis is the term used to describe a large group of diseases, which are characterized by loss of bone density, which makes the bones weaker. Osteoporosis often occurs in postmenopausal women.

Calcitonin is a hormone found in the human body. Together with other substances, it regulates the concentration of calcium in the blood and inhibits the natural resorption of bone. Both medications in this study contain salmon calcitonin (sCT), because this form of calcitonin is more active than human calcitonin when used as a medicine.

The calcitonin Nasal Spray used in this study is registered and available to doctors in United States for the treatment of osteoporosis. The medication being tested in this study is an oral tablet form of salmon calcitonin.

FGF-23 Suppressibility by Calcitonin [Recruiting]
Introduction:

Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important regulator of FGF-23 production and secretion in healthy humans.

Aim:

In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy men.

Study Design:

placebo-controlled, cross-over study

Method:

- All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml

NaCl 0. 9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously

- On both occasions frequent bloodsampling will take place, out an indwelling catheter in

de forearm vein.

- Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes

- Mealtimes: Calcium and Phosphate intake standardized on both occasions

- All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics,

San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that measures only intact FGF-23

- Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca,

albumin, PO4, PTH, 25-OHD and 1,25-OHD

Endpoint:

A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.

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