A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women
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|ClinicalTrials.gov Identifier: NCT00803686|
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : June 9, 2014
Last Update Posted : June 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Phase 1 Pharmacodynamic Study||Drug: Oral rsCT tablet Drug: Oral Placebo Tablet Drug: Fortical (rsCT) nasal spray||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
Experimental: Part 1 Double Blind Oral rsCT Tablet
Intervention: Oral rsCT tablet given once 4 hours after evening meal.
Drug: Oral rsCT tablet
On Study Day 1, subjects will be given their assigned treatment, based on one of two randomly ordered treatment sequences, at 10 PM (22:00). On Visit 3, subjects will return for administration of the second treatment with a minimum of 7 days washout interval between study drug administrations. On Visit 4, subjects will return for administration of third treatment of rsCT, either oral rsCT tablets or Fortical (rsCT) nasal spray. Interventions are described in Intervention Name, Other Names and in Intervention Description.
Other Name: rsCT
Placebo Comparator: Part 1, Double-blind Oral Placebo Tablet
Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal
Drug: Oral Placebo Tablet
Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.
Other Name: Placebo
Experimental: Part 2 Open label, Oral rsCT tablet
Intervention: Oral rsCT tablet given once 2 hours after evening meal.
Drug: Oral rsCT tablet
Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.
Active Comparator: Part 2, Open Label Fortical Nasal Spray
Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal
Drug: Fortical (rsCT) nasal spray
Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.
Other Name: Fortical nasal spray
- Pharmacodynamic Effect of Oral Calcitonin [ Time Frame: 12 hr ]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
- Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women [ Time Frame: 12 hours ]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).
- AUCInhibition=Hours*%P [ Time Frame: 12 Hours ]The AUCinhibition, (Area Under the Inhibition Curve) in hours*%inhibition vs placebo under the baseline line over the curve.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803686
|United States, Missouri|
|Bio-Kinetic Clinical Applications, Inc.|
|Springfield, Missouri, United States, 65802|
|Principal Investigator:||Thomas Legg, D.O.||Bio-Kinetic Clinical Applications, Inc.|