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. 
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. 
days to men and women presenting with osteoarthritis (OA)... CONCLUSIONS: oSCT given twice daily with a pre-dinner and morning fasting dosing
Clinical Trials Related to Fortical (Calcitonin Nasal)
A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women [Completed]
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.
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.
A Study of Oral Recombinant Salmon Calcitonin (rsCT) to Prevent Postmenopausal Osteoporosis [Completed]
The primary purpose of this study was to evaluate the efficacy of oral calcitonin
(rsCT)tablets in the prevention of bone loss in postmenopausal women with lower bone mineral
density at increased risk of fracture. The secondary purpose of this study was to determine
if there is any food effect by comparing the efficacy and safety of oral calcitonin tablets
administered at dinner or at bedtime.
Calcitonin in the Treatment of Fibromyalgia [Enrolling by invitation]
The purpose of this study is to determine whether nasal administration of salmon calcitonin
is effective and safe in the treatment of symptoms and signs of primary fibromyalgia.
FGF-23 Suppressibility by Calcitonin [Recruiting]
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.
In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy
placebo-controlled, cross-over study
- 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
A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of
calcitonin 200 IU.
Reports of Suspected Fortical (Calcitonin Nasal) Side Effects
Hot Flush (3),
Back Pain (3),
Nasal Discomfort (2),
Musculoskeletal Stiffness (2),
Bone Density Decreased (2),
Rhinitis (2), more >>