Salmon Calcitonin Nasal Spray Research Articles

Salmon calcitonin plus intravaginal estriol: an effective treatment for the menopause

Intravaginal estriol (E3) effectively improves postmenopausal genito-urinary disturbances, without stimulating endometrial proliferation. The aim of the present study was to evaluate the effect of intravaginal estriol (E3) plus nasal spray salmon calcitonin (sCT), to improve neurovegetative symptoms and to prevent the decline of bone mineral density (BMD) of postmenopausal women. Two hundred and fourteen (214) healthy postmenopausal women were treated for 12 months with: (1) E3 (0.5 mg every other day) + Ca (0.5 g/day); (2) E3 + Ca + sCT (50 IU x 2/day); (3) sCT + Ca; (4) Ca. Climacteric complaints, such as hot flushes and sweating, BMD at the distal 1/10 of the radius, analyzed by dual photon absorptiometry, urinary excretion of hydroxyproline and serum alkaline phosphatase were evaluated at baseline and every 6 months. At the same time, patient compliance and drug tolerability were evaluated. E3 but not sCT, improved hot flushes and sweating. E3 blunted but not completely counteracted the BMD decline observed in women treated with only Ca, and reduced urinary hydroxyproline excretion. sCT markedly increased BMD values and reduced both urinary hydroxyproline excretion and serum alkaline phosphatase. These effects were not potentiated by E3 coadministration. All treatments were well tolerated. Present data indicate that the combined administration of intravaginal E3 and sCT may represent an alternative therapeutic regimen for those postmenopausal women who do not accept or have contraindications to classical hormone replacement therapy.

Patient responsiveness to calcitonin salmon nasal spray: a subanalysis of a 2-year study

A subanalysis of results from a randomized, double-blind, placebo-controlled, parallel-group, 2-year study was conducted to evaluate the response of individual patients to therapy with 200 IU/d calcitonin salmon nasal spray compared with placebo in postmenopausal women who had low bone mass. All patients received 500 mg/d of oral supplemental calcium. A response to therapy was defined as an increase from baseline in lumbar vertebral bone mineral density, measured by use of dual-energy x-ray absorptiometry, at the end of 2 years of treatment. Of 41 valid completers (ie, patients who met the entry criteria, were compliant with the protocol, and completed the study) treated with calcitonin salmon nasal spray, 31 (76%) responded positively to treatment. Of 40 valid completers who received placebo, 25 (63%) lost bone mass ( P = 0.001 between groups). The relative risk of bone loss for patients receiving calcitonin salmon nasal spray was 0.19 (95% confidence interval, 0.07 to 0.50), representing an 81% risk reduction. This subanalysis demonstrates that the benefits of calcitonin salmon nasal spray therapy were seen in the majority of women studied. Calcitonin salmon nasal spray represents an effective therapeutic alternative for osteoporotic women more than 5 years postmenopause who reject or cannot tolerate estrogens or for whom estrogens are contraindicated.

Prevention of further bone mass loss by nasal calcitonin in patients on long term glucocorticoid therapy for asthma: a two year follow up study.

Injectable calcitonin is effective in reducing spinal bone loss in steroid-dependent asthma but side effects are frequent. In contrast, a nasal spray presentation has been shown to be effective and well tolerated in involutional osteoporosis. To test the efficacy of nasal calcitonin a two year prospective trial was conducted in 44 steroid-dependent asthmatic patients. All patients received a calcium supplement of 1000 mg and were allocated randomly into two groups treated with either salmon calcitonin nasal spray (200 IU every other day, n = 22) or calcium alone (n = 22) for two years. All patients completed the first year of the study. Five patients in each group dropped out during the second year. In the calcitonin group one patient developed generalised pruritus and four lost steroid dependence, and in the calcium alone group five were no longer dependent on steroids. The efficacy of treatment was evaluated as follows: bone turnover assessed by biochemical markers, bone loss assessed by serial measurement of lumbar spine density, and rates of bone fractures. The bone mass in the calcitonin group increased by 2.7% in the first year while in the group receiving calcium alone it decreased by 2.8%; this difference was significant. Calcitonin prevented more bone loss during the second year while the calcium alone group continued losing bone mass (-7.8%). The difference between means was 0.1077 (95% CI 0.0381 to 0.1773). Three new fractures occurred in both groups. No changes in biochemical parameters were detected in either group. Calcitonin given intranasally increased spinal bone mass during the first year of treatment and maintained bone mass in a steady state during the second year. These results suggest that calcitonin may be a useful agent to prevent steroid-induced osteoporosis. However, the lack of effect of calcitonin on the rate of vertebral fractures does not permit its recommendation for routine use in preventing steroid-induced osteoporosis.

Effect of salmon calcitonin nasal spray on bone mass in patients with high turnover osteoporosis

Our results demonstrate that measurement of whole-body retention of [99mTc]MDP is a useful diagnostic tool in selecting postmenopausal osteoporotic women with different rates of bone turnover. This biophysical index showed good correlations with the biochemical estimates of both bone formation and bone resorption, confirming its validity as an estimate of skeletal turnover.

Salmon calcitonin nasal spray in corticosteroid — Induced osteoporosis

Salmon calcitonin nasal spray in corticosteroid — Induced osteoporosis

Effect on bone mass and bone turnover of a 2-year intermittent or continuous treatment with salmon calcitonin nasal spray in postmenopausal osteoporotic patients

Effect on bone mass and bone turnover of a 2-year intermittent or continuous treatment with salmon calcitonin nasal spray in postmenopausal osteoporotic patients

Nasal spray salmon calcitonin in the treatment of senile osteoporosis

A full-length cDNA clone encoding osteocalcin from the bullfrog, Rana catesbeiana (bone Gla-protein, BGP) has been isolated, and the complete coding sequence for the 100-amino-acid pre-pro-osteocalcin protein was determined. The amino acid sequence of Rana catesbeiana osteocalcin, especially the mature 49-amino acid sequence, is closer to the mammalian than to the fish, Sparus osteocalcin. Rana mature osteocalcin has a similarity of 67% with human or 59% with rat osteocalcin, and only 42% with fish mature osteocalcin. The 51-amino-acid pre-pro-peptide contains the expected hydrophobic leader sequence and the dibasic Arg-Arg sequence preceding the NH2-terminal Ser of the mature 49-amino-acid Rana osteocalcin. The pro-peptide sequence also contains the expected motif of polar and hydrophobic residues, which targets vitamin K-dependent gamma-carboxylation of three specific Glu residues at positions 17, 21, and 24 in the mature protein. At the native protein expression levels, extraction from Rana cortical bone in the presence of protease inhibitor cocktail resulted in the isolation of two distinct forms of osteocalcin, P-1 and P-2, with a 3:2 distribution. Using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF-MS) and amino acid sequence analysis of the N-terminal domain, we confirmed that P-1 is the intact 49-residue osteocalcin with N-terminal SNLRNAVFG·, and that P-2 lacks four amino acids from the N-terminus, (NAVFG·). These results demonstrate the existence of a form of osteocalcin lacking four N-terminal amino acids in Rana bone, and that mature Rana osteocalcins remained highly conserved in their molecular evolution, especially with respect to the conservation of the C-terminal domain (residues 14–49).

Increased vertebral bone density with a combination therapy of hPTH(1–38) and sequential salmon calcitonin nasal spray in osteoporotic patients

Increased vertebral bone density with a combination therapy of hPTH(1–38) and sequential salmon calcitonin nasal spray in osteoporotic patients

Effect of calcitonin on bone histomorphometry and bone metabolism in rheumatoid arthritis

Twenty-four women (mean age +/- SD 49 +/- 13 years) with classical or definite rheumatoid arthritis (disease duration 15 +/- 8 years) were treated with synthetic salmon calcitonin (SCT) nasal spray 200 IU three times a week for 3 months. Bone biopsies from the iliac crest were taken before and after SCT treatment. Histomorphometrical quantification of undecalcified bone sections was made using the manual point-counting method. SCT decreased the resorption surface of trabecular bone (ES/BS) significantly (P less than 0.001). There was also a significant increase (P less than 0.05) in trabecular bone volume (BV/TV) after 3 months of treatment, whereas no statistically significant changes were found in osteoid parameters. There were no significant changes in biochemical analyses of bone metabolism. We conclude that SCT might be useful in the prevention of bone loss in RA.

Use of nasally administered salmon calcitonin in preventing bone loss

This article reviews several of our studies in which we evaluated the effect of nasal salmon calcitonin in preventing bone loss in normal women just after menopause. In the first study, after treatment with nasal salmon calcitonin, bone loss stopped and, in fact, actually increased slightly. In contrast, the placebo group continued to lose bone mass. On the other hand, bone mass in the forearm, which has more cortical bone, showed no change in response to nasal salmon calcitonin. The effect of salmon calcitonin nasal spray in women with established osteoporosis has also been studied. In one study, bone mass in the forearm was constant in the group receiving nasal salmon calcitonin plus calcium, whereas bone mass in the placebo plus calcium group decreased by roughly 2%. Similarly, patients in the group without any treatment also lost 2%. The effect of nasal salmon calcitonin is probably the result of a reduction in the bone resorption to a level seen in premenopausal females. When women were divided according to their baseline bone turnover or initial bone mass, the women with the highest turnover level (assessed by alkaline phosphatase or fasting urinary hydroxyproline) or the lowest bone mass were the group with the greatest increase in bone mass. In conclusion, treatment with salmon calcitonin nasal spray in patients with established osteoporosis stops bone loss, normalizes bone turnover, and causes no subjective or objective side effects.

Acute effect of the intranasal administration of salmon calcitonin in osteoporotic women

Eleven women with primary osteoporosis (mean age, 63.1 years; range, 57–78) received in a random schema: placebo, 200 and 400 IU of salmon calcitonin nasal spray (sCT-NS) during 3 successive days. Total and ionized calcium and phosphate in serum were determined before and 5 h after calcitonin. Total hydroxyproline (THP) and creatinine excretion were measured in urine in three periods of 8 h each after calcitonin administration. The THP excretion after placebo administration showed a circadian rhythm with peak excretion during the night. This rhythm was not altered by sCT-NS administration at 8 a.m. but a sustained diminution of the THP/creatinine excretion was observed. The average decrease after 400 IU of sCT-NS was 9, 16 and 6% during the first, second and third periods of urine collection. Although the average effect of the 200 and 400 IU doses was similar, only the diminution induced by the latter dose on the 24-h period was statistically significant: placebo, 24.8 ± 2.9; 200 IU, 20.8 ± 2.9 ( P n.s.); 400 IU, 20.1 ± 2.2 mg/24 h ( P < 0.01). No significant changes were observed on serum except a fall provoked by the 400 IU dose upon ionized calcium (4.44 ± 0.08 to 4.37 ± 0.06 mg/dl; P < 0.05). The administration of 200 or 400 IU of sCT-NS provoked a sustained but moderate decrease of bone resorption on osteoporotic females of a lesser degree than the one observed in a previous study after the parenteral administration of 100 IU.

Effectiveness of Salmon Calcitonin Nasal Spray Preparation in the Treatment of ‘Chronic’ Headache Form

Effectiveness of Salmon Calcitonin Nasal Spray Preparation in the Treatment of ‘Chronic’ Headache Form

Salmon calcitonin (Miacalcic) nasal spray in prevention and treatment of osteoporosis.

Calcitonin (CT) constitutes one of the major choices for the pharmacologic treatment of postmenopausal and senile osteoporosis. In postmenopausal osteoporosis, CT, analogous to estrogens, determines increase of bone mass, improvement of intestinal calcium absorption and a positivization of calcium balance. Patients treated with CT can also benefit from the analgesic effect of the hormone. Unlike estrogens, these beneficial effects of CT occur with minimal risk and require no routine gynecological monitoring. In addition, CT is completely devoid of toxicity. The only limitations to the use of CT are linked to the frequent parenteral injections and the occurrence of side effects. These limitations can now be overcome by the availability of the new nasal spray preparation, which has been developed for synthetic salmon calcitonin (sCT). The introduction of this new form increases the patients' compliance, and the different pharmacokinetic curtails the side effects, compared to the parenteral administration. At present, one-year controlled studies have been reported, showing a beneficial effect of sCT on bone mass in patients with established osteoporosis. Also, shorter studies demonstrate the analgesic activity of sCT treatment in patients with vertebral crush fractures and bone pain. The improvement in the patients' compliance and the reduction of side effects allow this new CT preparation to be used in the prevention of postmenopausal osteoporosis.

Treatment of Paget's Disease of Bone with Salmon Calcitonin Nasal Spray

Subcutaneous daily or bidaily administration of synthetic salmon calcitonin is an effective form of therapy for Paget's disease, but the requirement for parenteral injection deters geriatric patients from using the drug. This study compares a new intranasal preparation of salmon calcitonin to subcutaneous drug in 18 patients with Paget's disease using two different protocols. In the first protocol, 15 patients not previously treated with salmon calcitonin were given the agent for 3 months by either the intranasal or subcutaneous route. Seven patients treated with intranasal calcitonin had a mean fall in the serum alkaline phosphatase of 33% over a 3-month period compared to a fall of 40% in the subcutaneously treated group; the difference between the two treatment groups was not statistically significant. In the second protocol, three patients previously stabilized on subcutaneous calcitonin were switched to the nasal spray with no subsequent change in alkaline phosphatase values during 6 months of treatment. These results demonstrate that intranasal salmon calcitonin is effective in lowering the serum alkaline phosphatase in Paget's disease. Ease of administration and patient acceptance make intranasal calcitonin a reasonable alternative for geriatric patients.

Salmon-calcitonin nasal spray in Paget's disease of bone: preliminary results in five patients.

The effectiveness of Synthetic Salmon Calcitonin (SSCT) administered as a nasal spray was assessed via clinical, biological, and radiological variables in 5 Pagetic patients during a 6 months course therapy, the results show that intranasal administration does not decrease the activity of SSCT in Paget's disease of bone.