Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women

NCTNCT00803686Other idUGL-OR0803Other idBio-Kinetic No.: 13808

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Calcitonin-salmon, does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Phase 2
Enrollment: 12 participants (actual)
Sponsor: Tarsa Therapeutics, Inc. · Industry
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Dec 2008
Primary completion: Jan 2009
Completion: Jan 2009
First posted: 5 Dec 2008 (estimated)
Last update posted: 9 Jun 2014 (estimated)
Conditions: Phase 1 Pharmacodynamic Study

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200820092010

Ph 2
A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women
NCT00803686
Dec 2008 to Jan 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is being conducted to assess the plasma CTx-1 concentrations when dosing is at night and to compare these results with those obtained with a placebo control and with commercially available nasal calcitonin.

Interventions

Oral rsCT tabletDrug
Oral Placebo TabletDrug
Oral rsCT tabletDrug
Fortical (rsCT) nasal sprayDrug

Arms4

Experimental
Part 1 Double Blind Oral rsCT Tablet
Intervention: Oral rsCT tablet given once 4 hours after evening meal.
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
Experimental
Part 2 Open label, Oral rsCT tablet
Intervention: Oral rsCT tablet given once 2 hours after 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

Primary outcomes1

Outcomes the sponsor listed as primary.

Pharmacodynamic Effect of Oral Calcitonin
Time frame · 12 hr
Registry description
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

Secondary outcomes(2)

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
Registry description
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
Registry description
The AUCinhibition, (Area Under the Inhibition Curve) in hours\*%inhibition vs placebo under the baseline line over the curve.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 hr

Pharmacodynamic Effect of Oral Calcitonin

Group	Value (percentage of time-matched placebo respo)	Spread
Part 1 Oral rsCT Tablets	37.5	13.2
Part 1 Oral Placebo Tablets	100	NA
Part 2 Oral rsCT Tablets	41.2	16.6
Part 2 Fortical Intra-nasal Spray	44.4	21.8

Secondary and other outcome results(2)

Secondary outcomeMean· 12 hours

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

Group	Value (Hours)	Spread
Part 1 Oral rsCT Tablets	7.5	5.0
Part 1 Oral Placebo Tablets	0	0
Part 2 Oral rsCT Tablets	4.5	5.0
Part 2 Fortical Intra-nasal Spray	4.0	3.5

Secondary outcomeMean· 12 Hours

AUCInhibition=Hours*%P

Group	Value (hours*%P)	Spread
Part 1 Oral rsCT Tablets	474.7	267.7
Part 1 Oral Placebo Tablets	0	0
Part 2 Oral rsCT Tablets	345.8	279.0
Part 2 Fortical Intra-nasal Spray	504.7	477.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Part 1 Oral rsCT TabletsSubjects were given oral rsCT tablets 4 hours after the evening meal	–	0 / 12	1 / 12
Part 1 Oral Placebo TabletsSubjects were given oral placebo tablets 4 hours after the evening meal.	–	0 / 12	3 / 12
Part 2 Open Label--Oral rsCT TabletsAfter completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.	–	0 / 5	0 / 5
Part 2 Open Label Fortical Intranasal SprayAfter completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal	–	0 / 4	1 / 4

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 45 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria * Postmenopausal female, in good health (at least five years since last menses). * Age greater than or equal to 45 years old and less than or equal to 70 years old * Weight ± 20% of the Metropolitan Life weight table. * Plasma CTx-1 greater than or equal to 0.25 ng/ml. * Total calcium, phosphorus, and magnesium within normal range. * Willing and able to comply with all study requirements. * Willing and able to sign written informed consent. * Negative urine pregnancy test at screening. * Negative Screen for Hepatitis B and C, HIV and drugs of abuse. Exclusion Criteria: * History of parathyroid, thyroid, pituitary or adrenal diseases. * History of musculoskeletal disease. * History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders. * History of cancer within 5 years of enrollment other than basal cell carcinoma. * History of regular use of a Non-Steroidal Anti-inflammatory Drug (NSAID). * History of surgery within 60 days of enrollment. * History of hypersensitivity or allergies (other than seasonal allergies) within -years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications. * Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study. * Use of bisphosphonates within 6 months, SERMS, estrogen or estrogen-like drugs 2 months, or calcitonin 1 month. * Presence of any clinically significant illness. * Unwilling or unable to comply with all study requirements. * Unwilling or unable to sign written, informed consent. * History of drug or alcohol abuse. * Participation in any clinical study of an investigational drug within 60 days of enrollment. * Plasma CTx-1 less than 0.25 ng/mL.

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