Page last updated: 2024-11-12

salmon calcitonin

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Cross-References

ID SourceID
PubMed CID16133812
CHEMBL ID3989767
MeSH IDM0092392

Synonyms (8)

Synonym
calcitonin salmon
AKOS015994646
HS-2006
W-106060
AC-28735
mfcd00133859
CHEMBL3989767
salmon calcitoninsalmon calcitonin

Research Excerpts

Effects

ExcerptReferenceRelevance
"Salmon calcitonin has an amino acid sequences that would allow it to form an amphipathic helix from approximately residue 9 to residue 22. "( Deletion sequences of salmon calcitonin that retain the essential biological and conformational features of the intact molecule.
Epand, RF; Epand, RM; Orlowski, RC; Stafford, AR, 1988
)
2.03
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
metaboliteAny intermediate or product resulting from metabolism. The term 'metabolite' subsumes the classes commonly known as primary and secondary metabolites.
bone density conservation agentAn agent that inhibits bone resorption and/or favor bone mineralization and bone regeneration. Used to heal bone fractures and to treat bone diseases such as osteopenia and osteoporosis.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
heterodetic cyclic peptideA heterodetic cyclic peptide is a peptide consisting only of amino-acid residues, but in which the linkages forming the ring are not solely peptide bonds; one or more is an isopeptide, disulfide, ester, or other bond.
polypeptideA peptide containing ten or more amino acid residues.
peptide hormoneAny peptide with hormonal activity in animals, whether endocrine, neuroendocrine, or paracrine.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Bioassays (36)

Assay IDTitleYearJournalArticle
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1783436Ratio of EC50 for rat calcitonin receptor expressed in BHK-13 cells to EC50 for rat AMY3R (CT+RAMP3) expressed in tk-ts13 cells2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID249429Effect of compound on osteoclast resorption activity at concentration of 100 nM in rat femurs2005Journal of medicinal chemistry, Mar-10, Volume: 48, Issue:5
Synthesis of NO-donor bisphosphonates and their in-vitro action on bone resorption.
AID1783441Displacement of [125I]-calcitonin from rat calcitonin receptor expressed in tk-ts 13 cells measured after 120 mins by scintillation proximity assay2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1783431Agonist activity at human AMY3R (CT+RAMP3) expressed in Hollex1 cells incubated for 3 hrs by luminescence assay2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1783433Ratio of EC50 for human calcitonin receptor expressed in BHK570 cells to EC50 for human AMY3R (CT+RAMP3) expressed in Hollex1 cells2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1783439Ratio of IC50 for displacement of [125I]-calcitonin from human calcitonin receptor expressed in tk-ts 13 cells to IC50 for displacement of [125I]-amylin from human AMY3R (CTR+RAMP3) expressed in BHK-13 cells2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID249227Effect of compound on osteoclasts formation at concentration of 100 nM in rat femurs2005Journal of medicinal chemistry, Mar-10, Volume: 48, Issue:5
Synthesis of NO-donor bisphosphonates and their in-vitro action on bone resorption.
AID181335In vivo hypocalcemic activity measuring the hormone-induced decrease of blood calcium levels in rats1988Journal of medicinal chemistry, Aug, Volume: 31, Issue:8
Deletion sequences of salmon calcitonin that retain the essential biological and conformational features of the intact molecule.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1783438Displacement of [125I]-calcitonin from human calcitonin receptor expressed in tk-ts 13 cells measured after 120 mins by scintillation proximity assay2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1783440Displacement of [125I]-amylin from rat AMY3R (CTR+RAMP3) expressed in BHK-13 cells measured after 120 mins by scintillation proximity assay2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1783437Displacement of [125I]-amylin from human AMY3R (CTR+RAMP3) expressed in BHK-13 cells measured after 120 mins by scintillation proximity assay2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1783435Agonist activity at rat calcitonin receptor expressed in BHK-13 cells assessed as increase in intracellular cAMP concentration incubated for 25 mins by CRE luciferase reporter gene assay2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1783434Agonist activity at rat AMY3R (CT+RAMP3) expressed in tk-ts13 cells assessed as increase in intracellular cAMP level incuabted for 25 mins by CRE luciferase reporter gene assay2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1783442Ratio of IC50 for displacement of [125I]-calcitonin from rat calcitonin receptor expressed in tk-ts 13 cells to IC50 for displacement of [125I]-amylin from rat AMY3R (CTR+RAMP3) expressed in BHK-13 cells2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
AID1783432Agonist activity at human calcitonin receptor expressed in BHK570 cells assessed as increase in intracellular cAMP concentration incubated for 3 hrs in absence of albumin by CRE luciferase reporter gene assay2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Development of Cagrilintide, a Long-Acting Amylin Analogue.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (4)

TimeframeStudies, This Drug (%)All Drugs %
pre-19901 (25.00)18.7374
1990's0 (0.00)18.2507
2000's1 (25.00)29.6817
2010's1 (25.00)24.3611
2020's1 (25.00)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 59.10

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index59.10 (24.57)
Research Supply Index1.79 (2.92)
Research Growth Index4.66 (4.65)
Search Engine Demand Index90.71 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (59.10)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Reviews1 (20.00%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other4 (80.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (44)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Improving the Sensitivity of Sestamibi SPECT-CT Parathyroid Scan With Calcitonin Pre-treatment for Primary Hyperparathyroidism [NCT03935984]Phase 437 participants (Anticipated)Interventional2019-05-29Recruiting
Assessing Quality of Life Changes Using Calcitonin in Patients With Hypothyroidism on Biochemical Replacement With Levothyroxine [NCT03342001]Phase 411 participants (Actual)Interventional2018-06-18Completed
Treatment of Aggressive Central Giant Cell Granuloma [NCT02358304]Phase 224 participants (Actual)Interventional2007-09-30Completed
Beijing Osteoporosis With Neurological Disorders in Epigenetic Changes Study: an Ambispective, Multicentre, Open Cohort Study [NCT03401619]2,000 participants (Anticipated)Observational [Patient Registry]2017-09-21Active, not recruiting
The Pre-emptive Value of Epidural Calcitonin in Patients With Lower Limb Amputation. A Double Blinded Randomized Study [NCT02115360]60 participants (Actual)Interventional2014-04-30Completed
Provoked Migraine Attacks With Calcitonin Gene-related Peptide (CGRP) in Patients Who Have Tried Preventive Treatment With Anti-CGRP Monoclonal Antibodies. [NCT03481400]40 participants (Anticipated)Interventional2016-07-31Recruiting
Diagnostic Values of C-reactive Protein and Procalcitonin in Predicting Bacterial Infection in Acute Exacerbations of Chronic Obstructive Pulmonary Disease [NCT03923803]90 participants (Anticipated)Observational2019-07-31Not yet recruiting
Clinical Characteristics and Pathophysiology of Post-Traumatic Headache [NCT03791515]200 participants (Actual)Interventional2018-07-26Completed
A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating the Safety and Efficacy of Oral Recombinant Salmon Calcitonin (rsCT) in the Prevention of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture [NCT01292187]Phase 2129 participants (Actual)Interventional2011-01-31Completed
Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study [NCT00688077]49 participants (Actual)Interventional2008-05-31Completed
The Effect of Sumatriptan and Placebo on CGRP Induced Headache [NCT03542357]30 participants (Actual)Interventional2018-02-15Completed
Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine [NCT04019496]44 participants (Actual)Observational2019-01-29Completed
[NCT00620854]Phase 224 participants (Actual)Interventional2008-02-29Completed
Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis [NCT00414973]Phase 3364 participants (Actual)Interventional2006-12-31Completed
Phase IV Study of Nasal Salmon Calcitonin in the Treatment of Symptoms and Signs of Fibromyalgia [NCT00754884]Phase 40 participants (Actual)Interventional2008-10-31Withdrawn(stopped due to Study drug was not longer available in our country.)
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis [NCT00486434]Phase 31,176 participants (Actual)Interventional2007-05-31Completed
Optimizing Diagnostic Accuracy of Fine Needle Aspiration Biopsy Calcitonin Measurements in Detecting Medullary Thyroid Carcinoma [NCT06067594]155 participants (Actual)Observational [Patient Registry]2018-03-01Completed
A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Crossover Phase I Study Assessing Pharmacokinetics and Pharmacodynamics of Two Different SMC021 0.8 mg Variants and the Effect of Timing of Drug Intake in Healthy Postmenopausal Women [NCT00411125]Phase 186 participants Interventional2006-08-31Completed
The Use of Intranasal Calcitonin to Improve Pain and Activity in Elderly Pelvic Ring Injuries [NCT03812991]Phase 421 participants (Actual)Interventional2019-07-01Completed
Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis [NCT00542984]Phase 370 participants (Actual)Interventional2003-08-31Completed
Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis [NCT00543023]Phase 3104 participants (Actual)Interventional2003-06-30Completed
Comparison of Teriparatide and Calcitonin in the Treatment of Postmenopausal Women With Osteoporosis [NCT00543218]Phase 363 participants (Actual)Interventional2002-12-31Completed
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study. [NCT00486317]Phase 10 participants Interventional2005-10-31Completed
SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study. [NCT00486369]Phase 10 participants Interventional2007-01-31Completed
Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs [NCT00444808]Phase 419 participants (Actual)Interventional2007-02-28Terminated(stopped due to Medication expired)
Use of Intranasally Administered Calcitonin in the Treatment of Osteopenia and Osteoporosis in Children, Adolescents and Young Adults With IBD: A Pilot Study [NCT00114803]66 participants Interventional2004-01-31Completed
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D [NCT00525798]Phase 34,665 participants (Actual)Interventional2007-03-31Completed
Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women [NCT00239889]Phase 4300 participants Interventional2002-03-31Completed
A Partially-Blind, Randomized, Single-Dose, Placebo-Controlled Crossover Phase I Study Assessing the Effect of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of SMC021 0.8 mg in Healthy Postmenopausal Women [NCT00395395]Phase 156 participants (Anticipated)Interventional2006-10-31Completed
Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by [NCT00363532]12 participants (Anticipated)Interventional2006-09-30Completed
Effect of Early Calcitonin Therapy on Incidence and Severity of Neuropathic Pain After Spinal Cord Injury [NCT05805683]50 participants (Anticipated)Interventional2023-05-01Recruiting
Evaluation of the Effects of Salmon Calcitonin Nasal Spray Compared to Placebo on Bone Microarchitecture Measured by High Resolution Peripheral Micro- Computed-tomography Over 2 Years in Postmenopausal Women (a Pilot Study) [NCT00372099]Phase 390 participants (Actual)Interventional2007-01-31Completed
Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis [NCT00376311]Phase 254 participants Interventional2002-09-30Terminated
The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients [NCT04452929]72 participants (Anticipated)Interventional2020-07-22Recruiting
Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab [NCT04592952]Phase 4400 participants (Anticipated)Interventional2020-10-08Recruiting
[NCT00004358]Phase 29 participants Interventional1992-11-30Completed
Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus [NCT00478335]4 participants (Actual)Interventional2007-05-31Completed
MR-Angiografi (MRA) og MR-Spektroskopi (MRS) Hos Raske forsøgspersoner og Patienter Med migræne Uden Aura Provokeret Med Calcitonin Gen-relateret Peptid (CGRP) og Sildenafil [NCT03143465]36 participants (Anticipated)Interventional2016-08-31Active, not recruiting
A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Salmon Calcitonin in the Treatment of Subjects With Knee Osteoarthritis [NCT00704847]Phase 31,030 participants (Actual)Interventional2008-06-30Terminated(stopped due to Male subjects were terminated due to an imbalance in prostate cancer events)
CGRP's Cluster Headache Inducing Abilities in Cluster Headache Patients [NCT02466334]37 participants (Actual)Interventional2015-06-30Completed
A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal Women [NCT00803686]Phase 212 participants (Actual)Interventional2008-12-31Completed
A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Parallel Group, 48-Week, Study of Oral Recombinant Salmon Calcitonin (rsCT) Compared to Salmon Calcitonin (sCT) Nasal Spray in Postmenopausal Osteoporotic Women [NCT00959764]Phase 3565 participants (Actual)Interventional2009-06-30Completed
Efficacy of Coadministration of Calcitonin and Hyperbaric Bupivacaine on Spinal Anesthesia in Lower Abdominal and Limb Surgeries in Tramadol-abuse Patients: a Randomized Controlled Trial [NCT04445857]Phase 490 participants (Actual)Interventional2020-09-01Completed
Calcitonin for Treating X-linked Hypophosphatemia [NCT01652573]21 participants (Actual)Interventional2011-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00414973 (6) [back to overview]Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men
NCT00414973 (6) [back to overview]Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men
NCT00414973 (6) [back to overview]Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women
NCT00414973 (6) [back to overview]Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women
NCT00414973 (6) [back to overview]Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men
NCT00414973 (6) [back to overview]Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women
NCT00478335 (1) [back to overview]24h Urine Volume
NCT00486434 (7) [back to overview]Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee
NCT00486434 (7) [back to overview]Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.
NCT00486434 (7) [back to overview]Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.
NCT00486434 (7) [back to overview]Changes in Biochemical Markers of Bone & Cartilage Metabolism.
NCT00486434 (7) [back to overview]Disease Progression in the Knee Evaluated by MRI.
NCT00486434 (7) [back to overview]Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months
NCT00486434 (7) [back to overview]Nature and # of AEs Monitored Continuously During Study
NCT00525798 (2) [back to overview]Number of Patients With New Vertebral Fractures
NCT00525798 (2) [back to overview]Number of Patients With Non-vertebral Fractures
NCT00620854 (1) [back to overview]Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)
NCT00704847 (8) [back to overview]Knee Disease Progression Assessed by MRI
NCT00704847 (8) [back to overview]Questionnaire to Assess Function and Physical Activity
NCT00704847 (8) [back to overview]Questionnaire to Assess Pain
NCT00704847 (8) [back to overview]Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months
NCT00704847 (8) [back to overview]Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index
NCT00704847 (8) [back to overview]Questionnaire to Assess Health-related Quality of Life
NCT00704847 (8) [back to overview]Questionnaire to Assess Stiffness in the Signal Knee.
NCT00704847 (8) [back to overview]Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).
NCT00803686 (3) [back to overview]AUCInhibition=Hours*%P
NCT00803686 (3) [back to overview]Pharmacodynamic Effect of Oral Calcitonin
NCT00803686 (3) [back to overview]Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women
NCT00959764 (3) [back to overview]Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)
NCT00959764 (3) [back to overview]Change in Plasma CTx-1 From Baseline
NCT00959764 (3) [back to overview]Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine
NCT01292187 (2) [back to overview]Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.
NCT01292187 (2) [back to overview]Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.
NCT01652573 (18) [back to overview]Area Under the Curve for 1,25(OH)2vitamin D
NCT01652573 (18) [back to overview]Area Under the Curve for 1,25(OH)2vitamin D
NCT01652573 (18) [back to overview]Area Under the Curve for FGF23
NCT01652573 (18) [back to overview]Area Under the Curve for FGF23
NCT01652573 (18) [back to overview]Area Under the Curve for TmP/GFR
NCT01652573 (18) [back to overview]Area Under the Curve for TmP/GFR
NCT01652573 (18) [back to overview]Number of Participants With Allergic Reactions at 1 Month
NCT01652573 (18) [back to overview]Number of Participants With Allergic Reactions at 2 Months
NCT01652573 (18) [back to overview]Number of Participants With Allergic Reactions at 3 Months
NCT01652573 (18) [back to overview]Number of Participants With Allergic Reactions at Baseline
NCT01652573 (18) [back to overview]Number of Participants With Nasal Congestion at 1 Month
NCT01652573 (18) [back to overview]Number of Participants With Nasal Congestion at 2 Months
NCT01652573 (18) [back to overview]Number of Participants With Nasal Congestion at 3 Months
NCT01652573 (18) [back to overview]Number of Participants With Nasal Ulceration at 1 Month
NCT01652573 (18) [back to overview]Number of Participants With Nasal Ulceration at 2 Months
NCT01652573 (18) [back to overview]Number of Participants With Nasal Ulcerations at 3 Months
NCT01652573 (18) [back to overview]Number of Participants With Nasal Ulcerations at Baseline
NCT01652573 (18) [back to overview]Number of Patients With Nasal Congestion at Baseline
NCT03342001 (1) [back to overview]Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease

Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men

Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. (NCT00414973)
Timeframe: Baseline to 24 weeks

Interventionpercentage change in total hip BMD (Least Squares Mean)
Teriparatide - Males0.37
Calcitonin - Males1.34

[back to top]

Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men

Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. (NCT00414973)
Timeframe: Baseline to 24 weeks

Interventionpercentage change in lumbar spine BMD (Least Squares Mean)
Teriparatide - Males6.01
Calcitonin - Males3.38

[back to top]

Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women

Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. (NCT00414973)
Timeframe: Baseline to 24 weeks

Interventionpercentage change in lumbar spine BMD (Least Squares Mean)
Teriparatide - Females6.04
Calcitonin - Females1.65

[back to top]

Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women

Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline. (NCT00414973)
Timeframe: Baseline to 24 weeks

Interventionpercentage change in total hip BMD (Least Squares Mean)
Teriparatide - Females-0.53
Calcitonin - Females-0.62

[back to top]

Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men

Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. (NCT00414973)
Timeframe: Baseline to 12 weeks and 24 weeks

,
Interventionpercentage change in osteocalcin (Median)
Week 12 Percentage Change (n=21, n=11)Week 24 Percentage Change (n=21, n=11)
Calcitonin - Males4.35-17.65
Teriparatide - Males107.2779.26

[back to top]

Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women

Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline. (NCT00414973)
Timeframe: Baseline to 12 weeks and 24 weeks

,
Interventionpercentage change in osteocalcin (Median)
Week 12 Percentage Change (n=202, n=102)Week 24 Percentage Change (n=191, n=97)
Calcitonin - Females-7.67-10.58
Teriparatide - Females113.87137.45

[back to top]

24h Urine Volume

urine volume in mL/d (NCT00478335)
Timeframe: 4-days

,
Interventionurine volume in mL/d (Mean)
Period 1Period 2
Experimental First Then Standard64756652
Standard First Then Experimental41784188

[back to top]

Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscore in the Signal Knee

WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain). (NCT00486434)
Timeframe: Change from baseline to 24 months

InterventionUnits on a scale (Median)
Active Arm-124.0
Placebo Arm-109.0

[back to top]

Joint Space Width (JSW) in the Medial Tibiofemoral Knee Joint in Signal Knee Measured by X-ray After 24 Months.

The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24. (NCT00486434)
Timeframe: Change from baseline to 24 months

Interventionmm (Mean)
Active Arm-0.188
Placebo Arm-0.198

[back to top]

Western Ontario and McMaster Universities Arthritis Index (WOMAC) Function Subscore in the Signal Knee.

WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of difficulty for performing each daily function listed in the questionnaire. 0 is no difficulty (best), 100 is extreme difficulty (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 1700. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less difficulty). (NCT00486434)
Timeframe: Change from baseline to 24 months

InterventionUnits on a scale (Median)
Active Arm-390.0
Placebo Arm-299.5

[back to top]

Changes in Biochemical Markers of Bone & Cartilage Metabolism.

The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX-I/creatinine and CTX-II/creatinine. It was originally planned that serum CTX-II would be measured, but this was not done. (NCT00486434)
Timeframe: From Baseline to Month 24

,
Interventionpercentage of change (Mean)
Serum CTX-I (ng/mL)Serum Osteocalcin (ng/mL)24-h urine CTX-I/creatinine (µg/mmol)24-h urine CTX-II/creatinine (ng/mmol)
Active Arm41.358-9.134-8.9590.484
Placebo Arm62.8831.7858.31111.266

[back to top]

Disease Progression in the Knee Evaluated by MRI.

Disease progression in the signal knee (cartilage volume and thickness) were evaluated by magnetic resonance imaging (MRI). MRIs were performed for patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site. (NCT00486434)
Timeframe: From Baseline to Month 24

,
Interventionpercentage of change (Mean)
Total cartilage volume m12Total cartilage volume m24Total cartilage thickness m12Total cartilage thickness m24
Active Arm2.904.791.99213.1777
Placebo Arm0.261.940.43432.2467

[back to top]

Effect on Hand Osteoarthritis (OA) Assessed by X-ray & Questionnaire From Baseline to 24 Months

"To assess disease progression of OA affected joints, X-rays of both hands were performed & assessed by two central readers (at Synarc). Hand OA was assessed by calculating total score for osteophytes, cyst erosion, & joint space narrowing, each of which were based on sum of left and right hand X-ray analysis with possible scores of 0-66. The overall total score (possible range 0-198) was also used. Higher scores (closer to 66 or to 198 when using overall total score) imply a worse outcome. Hand analyses were based on double readings, and the mean was used in the analyses.~The AUStralian/CANadian Osteoarthritis Hand Index (AUSCAN) questionnaire was also used for assessment of hand OA. It measures pain (5 questions), stiffness (1 question) and difficulties with daily activities (9 questions) through a visual analogue scale (0-100mm; 0 = lowest score; 100 = highest score). Lower AUSCAN scores represent a better outcome. Change (from baseline to month 24) in these scores was calculated." (NCT00486434)
Timeframe: Baseline and Month 24

,
InterventionScores on a scale (Mean)
Total osteophytesTotal JSNTotal cyst/erosionsTotal osteophytes, JSN and cyst/erosionsAUSCAN total score
Active Arm0.400.450.831.68-51.5
Placebo Arm0.400.620.821.84-38.1

[back to top]

Nature and # of AEs Monitored Continuously During Study

Adverse events were by system organ class of all patients. (NCT00486434)
Timeframe: From Baseline to Month 24

,,
InterventionNumber of AEs by system organ class (Number)
Any primary system organ classBlood and lymphatic system disordersCardiac disordersCongenital, familial and genetic disordersEar and labyrinth disordersEndocrine disordersEye disordersGastrointestinal disordersGeneral disorders and administration site condit.Hepatobiliary disordersImmune system disordersInfections and infestationsInjury, poisoning and procedural complicationsInvestigationsMetabolism and nutrition disordersMusculoskeletal and connective tissue disordersNeoplasms benign, malignant and unspecifiedNervous system disordersPsychiatric disordersRenal and urinary disordersReproductive system and breast disordersRespiratory, thoracic and mediastinal disordersSkin and subcutaneous tissue disordersSurgical and medical proceduresVascular disorders
Active Arm5481838114917268601182318753762312796281918486927160
Placebo Arm520163001292215053104249955364267168727142049363092
Total1068346812618394181132112480182106140498431835533389710557252

[back to top]

Number of Patients With New Vertebral Fractures

"The primary variable was the occurrence or not of a new vertebral fracture during the 3 year observation period. New vertebral fractures were identified from an assessment of x-ray of the lateral spine through time (at baseline and at yearly intervals thereafter).~The outcome is the number of new vertebral fractures from baseline to 36 months." (NCT00525798)
Timeframe: From baseline to month 36

InterventionParticipants (Number)
SMC02194
Placebo99

[back to top]

Number of Patients With Non-vertebral Fractures

"The secondary outcome was the occurrence or not of a non-vertebral fracture during the 3 year observation period. Non-vertebral fractures of interest were: hip fractures, forearm fractures, humurus fractures, rib fractures and clavicular fractures.~Any new non-vertebral fractures while on-study were recorded. A copy of radiographs confirming the fracture, as well as a copy of the radiologist's report was to be obtained. A copy of the emergency room discharge letter or a hospital discharge letter was also obtained." (NCT00525798)
Timeframe: From baseline to month 36

InterventionParticipants (Number)
SMC02175
Placebo82

[back to top]

Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)

This study compared the exposure to recombinant salmon calcitonin (rsCT), as measured by a decrease in plasma C-terminal telopeptide of type I collagen (CTx-1), of single doses of rsCT tablets containing 150 µg and 200 µg rsCT, respectively, with Fortical® nasal spray. (NCT00620854)
Timeframe: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB

Intervention% Change in Baseline CTx-1 (Mean)
rsCT A-74.17
rsCTB-71.99
Fortical®-68.40

[back to top]

Knee Disease Progression Assessed by MRI

Knee cartilage volume and thickness was assessed by MRI in patients from the sites in Ballerup, Denmark, the Czech Republic, and Romania using a quality controlled low-field 0.18T C-Span scanner from Esaote dedicated to the imaging of extremities. The same solenoid coil was used for all patients at a given site. (NCT00704847)
Timeframe: From baseline to month 12 and month 24

,
Interventionpercentage of change (Mean)
Cartilage Volume Month 12Cartilage Volume Month 24Cartilage Thickness Month 12Cartilage Thickness Month 24
SMC021 Oral Calcitonin3.42.64.74.5
SMC021 Placebo3.03.54.74.1

[back to top]

Questionnaire to Assess Function and Physical Activity

"Function and physical activity were assessed by assessed by WOMAC function sub-score in the signal knee. The criteria for assessment of the functional classification according to the American Rheumatism Association (ARA) were as follows (Hochberg et al 1992):~I. Completely able to perform usual activities of daily living (self-care, vocational and avocational) II. Able to perform usual self-care and vocational activities, but limited in avocational activities.~III. Able to perform usual self-care activities, but limited in vocational and avocational activities.~IV. Limited ability to perform usual self-care activities, vocational and avocational activities.~Self-care activities included dressing, feeding, bathing, grooming, and toileting. Avocational (recreational and/or leisure) and vocational (work, school, homemaking) activities were patient-desired and age- and sex-specific." (NCT00704847)
Timeframe: From baseline to months 1, 6, 12 and 24

,
Interventionpercentage of change (Mean)
Month 1Month 6Month 12Month 24
SMC021 Oral Calcitonin-4.8-22.6-28.0-30.3
SMC021 Placebo-1.9-17.9-28.4-25.1

[back to top]

Questionnaire to Assess Pain

"Pain was assessed by the WOMAC subscore in the signal knee by visit. Patients assessed their current pain level using a 100 mm visual analogue scales (VAS) by placing an X on the line that best describes his/her pain, where 0 equaled No Pain and 100 equaled Worst Pain Imaginable. Patients were instructed not to take analgesics for 3 days prior to the VAS." (NCT00704847)
Timeframe: Baseline, month 1, month 6, month 12, month 24

,
Interventionpercentage of change (Mean)
Month 1Month 6Month 12Month 24
SMC021 Oral Calcitonin-6.7-26.9-31.0-35.1
SMC021 Placebo-9.1-26.9-34.6-37.1

[back to top]

Joint Space Width (JSW) in the Medial Tibia-femoral Knee Joint in the Signal Knee Measured by X-ray Change From Baseline Over 24 Months

The signal knee was chosen prior to randomization based on which knee met the inclusion and exclusion criteria. The JSW is the space measured in mm between the 2 bones in the knee joint and this is assessed by x-ray. The JSW decreases with disease progression. The lower limit for participation in the trial were 2 mm JSW. There were no upper limit as long as inclusion and exclusion criteria were met. The outcome was measured as a change in JSW from baseline to month 24. (NCT00704847)
Timeframe: Change from baseline to 24 months

Interventionmm (Mean)
SMC021 Oral Calcitonin-0.32
SMC021 Placebo-0.40

[back to top]

Pain Subscore Change From Baseline Over 24 Months as Assessed by Western Ontario and McMaster Universities Arthritis (WOMAC) Index

WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the pain associated with performing each daily activity listed in the questionnaire. 0 is no pain (best), 100 is extreme pain (Worst). The total pain sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 500. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less pain). (NCT00704847)
Timeframe: Change from baseline to 24 months

InterventionUnits on a scale (Mean)
SMC021 Oral Calcitonin-80.6
SMC021 Placebo-87.9

[back to top] [back to top]

Questionnaire to Assess Stiffness in the Signal Knee.

"WOMAC's stiffness subscore was used to assess the stiffness in the signal knee. WOMAC is a self-administered set of standardized questionnaires to evaluate the condition of patients with osteoarthritis of the knee. The subject marks on a scale (1-100) the degree of joint stiffness for when performing each daily function listed in the questionnaire. 0 is no stiffness (best), 100 is extreme stiffness (worst). The total function sub score for the questions are then calculated. Total possible minimum sub score is 0, maximum is 200. The final outcome is the absolute change from baseline to 24 months. If the outcome is less that 0 there is improvement (less stiffness).~Patients were instructed not to take analgesics for 3 days prior to the WOMAC test." (NCT00704847)
Timeframe: Baseline to month 24

Interventionpercentage of change (Mean)
SMC021 Oral Calcitonin-26.1
SMC021 Placebo-20.3

[back to top]

Bone & Cartilage Metabolism Biochemical Marker Change (Percentage).

The central laboratory analyzed serum CTX-I (S-Crosslaps, Elecsys) and osteocalcin as well as urine CTX I/creatinine and CTX-II/creatinine. These biomarkers were analysed in order to assess the cartilage and bone turonver ratio to baseline at month 24. (NCT00704847)
Timeframe: From baseline to 24 months

,
Interventionpercentage of change (Mean)
Serum CTX-I (ng/mL)Serum Osteocalcin (ng/mL)24-h urine CTX-I/creatinine (µg/mmol)24-h urine CTX-II/creatinine (ng/mmol)
SMC021 Oral Calcitonin50.63.69.82.6
SMC021 Placebo40.63.97.22.3

[back to top]

AUCInhibition=Hours*%P

The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve. (NCT00803686)
Timeframe: 12 Hours

Interventionhours*%P (Mean)
Part 1 Oral rsCT Tablets474.7
Part 1 Oral Placebo Tablets0
Part 2 Oral rsCT Tablets345.8
Part 2 Fortical Intra-nasal Spray504.7

[back to top]

Pharmacodynamic Effect of Oral Calcitonin

C-terminal telopeptide of Collagen Type I (CTx-1) is an established plasma biomarker employed as an index of bone-resorption activity in response to interventions such as an anti-resorptive agent such as calcitonin. Here the calcitonin-salmon is rsCT, (recombinant) both oral and intranasal. These CTx-1 plasma concentrations were collected over 12 hours post-dosing where each subject served as her own control, as all received placebo in this crossover study, to account for the known diurnal variation of plasma CTx-1. For each time point, the ratio of the calcitonin response over the placebo response for that subject was derived from the plasma levels of CTx-1 and reported as a % of the placebo response (% Placebo or %P). These values were used to determine the primary pharmacodynamic parameter of Rmin, the minimum value seen following each active dose. The same %P values were used to derive the secondary pharmacodynamic parameters described in Secondary outc (NCT00803686)
Timeframe: 12 hr

Interventionpercentage of time-matched placebo respo (Mean)
Part 1 Oral rsCT Tablets37.5
Part 1 Oral Placebo Tablets100
Part 2 Oral rsCT Tablets41.2
Part 2 Fortical Intra-nasal Spray44.4

[back to top]

Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women

See Primary Outcome description. These CTx-1 plasma concentrations were collected over 12 hours, the values seen following active were compared with the time-matched individual values following placebo and used to derive the pharmacodynamic parameters. The primary was Rmin, seen above, and the Secondary ones were the time to that Rmin (Tmin) and the total time from the beginning of the inhibition to the end of the effect or the end of the study period (Tinhibition). (NCT00803686)
Timeframe: 12 hours

,,,
InterventionHours (Mean)
Tmin=time in hours to RminTInhibition=total time of effect in hours
Part 1 Oral Placebo Tablets00
Part 1 Oral rsCT Tablets7.510.9
Part 2 Fortical Intra-nasal Spray4.010.7
Part 2 Oral rsCT Tablets4.59.9

[back to top]

Change in Plasma C-terminal Telopeptide of Collagen 1 (CTx-1)

Change from baseline in plasma CTx-1 at 24 and 48 weeks. CTx-1 is an accepted plasma biomarker as evidence of an effect on bone resorption and the effect of oral calcitonin was compared to that of intranasal calcitonin, both vs placebo. (NCT00959764)
Timeframe: 24 weeks

Interventionpercentage change from baseline (Least Squares Mean)
Oral Calcitonin-42.93
Nasal Calcitonin-24.64
Placebo-21.09

[back to top]

Change in Plasma CTx-1 From Baseline

Percent change from baseline of plasma CTx-1 at end of study=48 weeks (NCT00959764)
Timeframe: 48 weeks

InterventionPercentage change from baseline (Least Squares Mean)
Oral Calcitonin-29.92
Nasal Calcitonin-11.41
Placebo-11.83

[back to top]

Percent Change From Baseline in Bone Mineral Density (BMD) of Axial Lumbar Spine

Bone Mineral Density is measured by Dual-Energy X-ray Absorptiometry (DXA) body scans. Two scans were taken for each timepoint(baseline, week 24 and week 48) and the mean of the two values was entered. The primary outcome timepoint was 48 weeks, but if a patient did not complete the full study, then the 24 week BMD value was used as Last Observation Carried Forward. The percentage change from the baseline value, set as 0%, was recorded as the primary outcome measure. (NCT00959764)
Timeframe: 48 weeks

InterventionPercentage increase from baseline (Least Squares Mean)
Oral Calcitonin1.53
Nasal Calcitonin0.76
Placebo0.47

[back to top]

Percentage Change From Baseline to Week 54 of Lumbar Spine Bone Mineral Density of Active Compared to Placebo.

(NCT01292187)
Timeframe: Baseline, Week 54

Interventionpercent change (Least Squares Mean)
Oral Calcitonin Tablets1.03
Oral Placebo Tablets-0.12

[back to top]

Percentage Change From Baseline to Week 54 of Plasma CTx-1 Following rsCT Compared to Placebo.

(NCT01292187)
Timeframe: Baseline, Week 54

Interventionpercent change (Least Squares Mean)
Oral rsCT Tablets-11.83
Oral Placebo Tablets8.37

[back to top]

Area Under the Curve for 1,25(OH)2vitamin D

Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated and results will be compared to baseline values. (NCT01652573)
Timeframe: Time 3 months

Interventionng/ml*hr (Least Squares Mean)
Nasal Calictonin1277.05
Saline Nasal Spray1258.84

[back to top]

Area Under the Curve for 1,25(OH)2vitamin D

Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated. (NCT01652573)
Timeframe: Time 0

Interventionng/ml*hr (Least Squares Mean)
Nasal Calictonin904.06
Saline Nasal Spray838.58

[back to top]

Area Under the Curve for FGF23

FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission and AUC calculated. (NCT01652573)
Timeframe: Time 0

Interventionpg/ml*hr (Least Squares Mean)
Nasal Calictonin3172.34
Saline Nasal Spray3215.34

[back to top]

Area Under the Curve for FGF23

FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission at 3 months and AUC calculated and compared to baseline. (NCT01652573)
Timeframe: 3 months

Interventionpg/ml*hr (Least Squares Mean)
Nasal Calictonin2698.38
Saline Nasal Spray2994.26

[back to top]

Area Under the Curve for TmP/GFR

Serum phosphate will be measured 0 to 24 hours postdose during a 24 hr admission, AUC calculated, and fasting Tmp/GFR calculated. (NCT01652573)
Timeframe: Time 0

Interventionmg/100 ml GF*hr (Least Squares Mean)
Nasal Calictonin30.70
Saline Nasal Spray29.97

[back to top]

Area Under the Curve for TmP/GFR

TmP/GFR will be measured 0 to 24 hours postdose during a 24 hr admission at 3 months and AUC calculated and compared to baseline. (NCT01652573)
Timeframe: Time 3 months

Interventionmg/100 ml GF*hr (Least Squares Mean)
Nasal Calictonin32.17
Saline Nasal Spray31.26

[back to top]

Number of Participants With Allergic Reactions at 1 Month

This symptom will be assessed. (NCT01652573)
Timeframe: Time 1 month

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray0

[back to top]

Number of Participants With Allergic Reactions at 2 Months

This symptom will be assessed. (NCT01652573)
Timeframe: Time 2 months

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray0

[back to top]

Number of Participants With Allergic Reactions at 3 Months

This symptom will be assessed. (NCT01652573)
Timeframe: Time 3 months

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray0

[back to top]

Number of Participants With Allergic Reactions at Baseline

This symptom will be assessed at baseline (NCT01652573)
Timeframe: Time 0

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray0

[back to top]

Number of Participants With Nasal Congestion at 1 Month

This symptom will be assessed. (NCT01652573)
Timeframe: Time 1 month

InterventionParticipants (Count of Participants)
Nasal Calictonin3
Saline Nasal Spray2

[back to top]

Number of Participants With Nasal Congestion at 2 Months

This symptom will be assessed. (NCT01652573)
Timeframe: Time 2 months

InterventionParticipants (Count of Participants)
Nasal Calictonin1
Saline Nasal Spray0

[back to top]

Number of Participants With Nasal Congestion at 3 Months

This symptom will be assessed. (NCT01652573)
Timeframe: Time 3 months

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray0

[back to top]

Number of Participants With Nasal Ulceration at 1 Month

This symptom will be assessed. (NCT01652573)
Timeframe: Time 1 month

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray2

[back to top]

Number of Participants With Nasal Ulceration at 2 Months

This symptom will be assessed. (NCT01652573)
Timeframe: Time 2 months

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray0

[back to top]

Number of Participants With Nasal Ulcerations at 3 Months

This symptom will be assessed. (NCT01652573)
Timeframe: Time 3 months

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray1

[back to top]

Number of Participants With Nasal Ulcerations at Baseline

This symptom will be assessed at baseline (NCT01652573)
Timeframe: Time 0

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray0

[back to top]

Number of Patients With Nasal Congestion at Baseline

This symptom will be assessed at baseline (NCT01652573)
Timeframe: Time 0

InterventionParticipants (Count of Participants)
Nasal Calictonin0
Saline Nasal Spray0

[back to top]

Modified City of Hope Quality of Life Questionnaire for Patients With Thyroid Disease

questionnaire to assess quality of life, 40 questions, 1-10 scale with 10 indicating more severe symptoms. Total 400 points, primary assessment was change in score after 6 weeks. (NCT03342001)
Timeframe: 6 weeks

Interventionscore on a scale (Mean)
Treatment Group, Open Label-36.33

[back to top]