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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.


See all Fortical indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Fortical (Calcitonin Nasal)

Efficacy and harms of nasal calcitonin in improving bone density in young patients with inflammatory bowel disease: a randomized, placebo-controlled, double-blind trial. [2011.08]
OBJECTIVES: There are very few published studies of agents having the potential to improve bone health in children with inflammatory bowel disease (IBD). The objective of this study was to establish the efficacy and safety of intranasal calcitonin in improving bone mineral density (BMD) in young patients with IBD and to define additional factors that impact bone mineral accrual... CONCLUSIONS: Intranasal calcitonin is well tolerated but does not offer a long-term advantage in youth with IBD and decreased BMD. Bone mineral accrual rate remains compromised in youth with IBD and low BMD raising concerns for long-term bone health outcomes. Improvement in nutritional status, catch-up linear growth, control of inflammation, increase in weight-bearing activity, and lower daily caffeine intake may be helpful in restoring bone density in children with IBD and low BMD.

The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study. [2010.02]
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)... CONCLUSIONS: oSCT given twice daily with a pre-dinner and morning fasting dosing resulted in reductions in markers of bone resorption and cartilage degradation. Copyright 2009 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Investigations of inter- and intraindividual relationships between exposure to oral salmon calcitonin and a surrogate marker of pharmacodynamic efficacy. [2010.01]
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 investigated correlations between exposure to sCT and levels of the bone resorption biomarker serum C-terminal telopeptide of collagen type I (CTX-I)... CONCLUSION: Increased bioavailability of orally administered 0.8 mg sCT was highly correlated with increased suppression of the bone resorption marker serum CTX-I irrespective of the time of day. However, the high inter- and intraindividual variability in sCT exposure demonstrates the importance of determining the optimum conditions for ensuring the most beneficial sCT uptake.

Biochemical markers identify influences on bone and cartilage degradation in osteoarthritis--the effect of sex, Kellgren-Lawrence (KL) score, body mass index (BMI), oral salmon calcitonin (sCT) treatment and diurnal variation. [2010]
oral salmon calcitonin (sCT) treatment and diurnal variation... CONCLUSION: Bone resorption was higher in females than males, while cartilage

The effect of oral salmon calcitonin delivered with 5-CNAC on bone and cartilage degradation in osteoarthritic patients: a 14-day randomized study. [2010]
days to men and women presenting with osteoarthritis (OA)... CONCLUSIONS: oSCT given twice daily with a pre-dinner and morning fasting dosing

more studies >>

Clinical Trials Related to Fortical (Calcitonin Nasal)

Calcitonin for Treating X-linked Hypophosphatemia [Recruiting]
X-linked hypophosphatemia (XLH) is the most common form of inherited rickets in the United States. It also causes bone disease in adults. XLH is caused by overproduction of a hormone call FGF23, which makes the body waste phosphate. This study is designed to determine if nasal calcitonin, an already approved drug in the US, can lower blood levels of FGF23 and reduce phosphate wasting in patients with XLH. In this study the investigators will:

1. Determine whether nasal calcitonin significantly lowers integrated 24-hour blood levels of FGF23 in patients with XLH.

2. Evaluate whether nasal calcitonin improves serum phosphate levels in XLH.

3. Assess whether nasal calcitonin improves blood levels of the active form of vitamin D and calcium absorption from the intestine.

4. Make sure that nasal calcitonin is safe and well tolerated.

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.

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.

more trials >>

Reports of Suspected Fortical (Calcitonin Nasal) Side Effects

Headache (3)Fatigue (3)Hot Flush (3)Back Pain (3)Nausea (3)Nasal Discomfort (2)Malaise (2)Musculoskeletal Stiffness (2)Bone Density Decreased (2)Rhinitis (2)more >>


Page last updated: 2013-02-10

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