CompletedNCT00803686Updated Jun 9, 2014Results posted

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

A Phase 2 interventional study of Oral rsCT tablet and Oral Placebo Tablet in Phase 1 Pharmacodynamic Study, sponsored by Tarsa Therapeutics, Inc.. Completed at 1 site in United States. Open to female participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-09.

Sponsored by Tarsa Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 45 Years to 70 Years
Sex: Female

Study summary

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.

Read the detailed description

Timing of the dose of recombinant salmon calcitonin (rsCT) is important in effecting reduction of osteoclast activity. It is theorized that a dose administered before bedtime will be more effective than a dose administered in the morning. See protocol summary for information.

Conditions studied

Phase 1 Pharmacodynamic Study

In context

Lead sponsor

Tarsa Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 70 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 12 participants (actual)

Study arms

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

Interventions

DrugOral 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.
Also known as: rsCT
DrugOral Placebo Tablet
Part 1, Double blind oral placebo tablet given once 4 hours after evening meal.
Also known as: Placebo
DrugOral rsCT tablet
Part 2, Open-label, oral rsCT tablet given once 2 hours after the evening meal.
DrugFortical (rsCT) nasal spray
Intervention: Open label, Fortical nasal spray given once 2 hours after the evening meal.
Also known as: Fortical nasal spray

What researchers measure

Primary outcomes

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
Time frame: 12 hr

Secondary outcomes

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).
Time frame: 12 hours
AUCInhibition=Hours*%P
The AUCinhibition, (Area Under the Inhibition Curve) in hours\*%inhibition vs placebo under the baseline line over the curve.
Time frame: 12 Hours

Results

Posted Jun 9, 2014

Participant flow

Part 1, Period 1

Participant flow — Part 1, Period 1
Milestone	Oral Recombinant Salmon Calcitonin (rsCT)	Oral Placebo
Started	6	6
Completed	6	6
Not completed	0	0

Part 1, Period 2

Participant flow — Part 1, Period 2
Milestone	Oral Recombinant Salmon Calcitonin (rsCT)	Oral Placebo
Started	6	6
Completed	6	6
Not completed	0	0

Part 2, Period 3

Participant flow — Part 2, Period 3
Milestone	Oral rsCT Tablets (Part 2, Period 3)	Fortical Nasal Spray (Part 2, Period 3)
Started	5	4
Completed	5	4
Not completed	0	0

Outcome measures

PrimaryPharmacodynamic 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

Time frame:: 12 hr
Reported as:: Mean · percentage of time-matched placebo respo

Pharmacodynamic Effect of Oral Calcitonin
percentage of time-matched placebo respo	Part 1 Oral rsCT Tablets	Part 1 Oral Placebo Tablets	Part 2 Oral rsCT Tablets	Part 2 Fortical Intra-nasal Spray
Pharmacodynamic Effect of Oral Calcitonin	37.5 ± 13.2	100 ± NA	41.2 ± 16.6	44.4 ± 21.8

SecondaryDerived 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).

Time frame:: 12 hours
Reported as:: Mean · Hours

Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women
Hours	Part 1 Oral rsCT Tablets	Part 1 Oral Placebo Tablets	Part 2 Oral rsCT Tablets	Part 2 Fortical Intra-nasal Spray
Tmin=time in hours to Rmin	7.5 ± 5.0	0 ± 0	4.5 ± 5.0	4.0 ± 3.5
TInhibition=total time of effect in hours	10.9 ± 2.0	0 ± 0	9.9 ± 2.6	10.7 ± 3.0

SecondaryAUCInhibition=Hours*%P

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

Time frame:: 12 Hours
Reported as:: Mean · hours*%P

AUCInhibition=Hours*%P
hours*%P	Part 1 Oral rsCT Tablets	Part 1 Oral Placebo Tablets	Part 2 Oral rsCT Tablets	Part 2 Fortical Intra-nasal Spray
AUCInhibition=Hours*%P	474.7 ± 267.7	0 ± 0	345.8 ± 279.0	504.7 ± 477.4

Adverse events

Collected over Any time within the treatment period up to 30 days after treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1 Oral rsCT Tablets	—	0/12 (0%)	1/12 (8.3%)
Part 1 Oral Placebo Tablets	—	0/12 (0%)	3/12 (25%)
Part 2 Open Label--Oral rsCT Tablets	—	0/5 (0%)	0/5 (0%)
Part 2 Open Label Fortical Intranasal Spray	—	0/4 (0%)	1/4 (25%)

Most frequent other events

Most frequent other events
Event	Part 1 Oral rsCT Tablets	Part 1 Oral Placebo Tablets	Part 2 Open Label--Oral rsCT Tablets	Part 2 Open Label Fortical Intranasal Spray
Nasal CongestionRespiratory, thoracic and mediastinal disorders	0/12	0/12	0/5	1/4
HeadacheNervous system disorders	1/12	0/12	0/5	0/4
Pain in extremityMusculoskeletal and connective tissue disorders	0/12	1/12	0/5	0/4
eyelid edemaMusculoskeletal and connective tissue disorders	0/12	1/12	0/5	0/4
abdominal pain upperGastrointestinal disorders	0/12	1/12	0/5	0/4

Baseline characteristics

Only 12 women entered Part 1, the two-period crossover portion of the study; hence the same 12 received both oral treatments and should not be counted twice. Only 9 of those 12 went on to Part 2, the open label, non-crossover portion of the study.

Age, Continuous
Age, Continuous(years)	Part 1 Oral rsCT Tablets	Part 1 Oral Placebo Tablets	Part 2 Open Label--Oral rsCT Tablets	Part 2 Open Label Fortical Intranasal Spray	Total
Mean	59.3 ± 4.7	59.3 ± 4.7	—	—	59.3 ± 4.7

Gender
Gender(participants)	Part 1 Oral rsCT Tablets	Part 1 Oral Placebo Tablets	Part 2 Open Label--Oral rsCT Tablets	Part 2 Open Label Fortical Intranasal Spray	Total
Female	6	6	—	—	12
Male	0	0	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Part 1 Oral rsCT Tablets	Part 1 Oral Placebo Tablets	Part 2 Open Label--Oral rsCT Tablets	Part 2 Open Label Fortical Intranasal Spray	Total
United States	6	6	—	—	12

post-menopausal healthy females
post-menopausal healthy females(participants)	Part 1 Oral rsCT Tablets	Part 1 Oral Placebo Tablets	Part 2 Open Label--Oral rsCT Tablets	Part 2 Open Label Fortical Intranasal Spray	Total
Number	6	6	—	—	12

post-menopausal females
post-menopausal females(participants)	Part 1 Oral rsCT Tablets	Part 1 Oral Placebo Tablets	Part 2 Open Label--Oral rsCT Tablets	Part 2 Open Label Fortical Intranasal Spray	Total
Number	6	6	—	—	12

Study locations

1 site

Bio-Kinetic Clinical Applications, Inc.
Springfield, Missouri 65802, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00803686
Lead sponsor: Tarsa Therapeutics, Inc.
Responsible party: Sponsor
First posted: Dec 5, 2008
Start date: Dec 2008
Primary completion: Jan 2009
Completion: Jan 2009
Results posted: Jun 9, 2014
Last update: Jun 9, 2014

Study contacts

Thomas Legg, D.O.

principal investigator · Bio-Kinetic Clinical Applications, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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