OsteoporosisPhase 2NCT00620854

A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women

A Phase 2 study testing Recombinant Salmon Calcitonin (rsCT), Oral Tablet and Nasal Spray in people with Osteoporosis, run by Tarsa Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT). Read more about this study

Who is it for?: Ages 45 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Osteoporosis
What is being tested?: Recombinant Salmon Calcitonin (rsCT), Oral Tablet and Nasal Spray
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Feb 2008to Apr 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Postmenopausal female, in good health (at least 5 years since last menses)
Age ≥45 and ≤70
Weight + or - 20% of the Metropolitan Life weight table
Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL
Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range
Willing and able to comply with all study requirements

Show all 9Show fewer

Willing and able to sign written informed consent
Negative urine pregnancy test at screening
Negative Screen for Hepatitis B and C, human immunodeficiency virus (HIV) and drugs of abuse

Who cannot join

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 non-steroidal anti-inflammatory drugs (NSAID)
History of surgery within 60 days of enrollment

Show all 15Show fewer

History of hypersensitivity or allergies (other than seasonal allergies) within 5 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, selective selective estrogen receptor modulators (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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).

Conditions: Osteoporosis
Being tested: Recombinant Salmon Calcitonin (rsCT), Oral Tablet, Nasal Spray
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Salmon Calcitonin (rsCT)Drug
Also called Fortical® nasal spray
Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.
Oral TabletDrug
0.15 mgs recombinant salmon calcitonin, single oral dose
Oral TabletDrug
0.2mgs recombinant salmon calcitonin, single oral tablet
Nasal SprayDrug
200 IU recombinant salmon calcitonin, single intranasal spray

Study groups in NCT00620854
Study group	Role	What they receive
rsCTA	Experimental	Oral Tablet Receives: Drug: Oral Tablet
rsCTB	Experimental	Oral Tablet Receives: Drug: Oral Tablet
Fortical	Active comparator	Nasal Spray Receives: Drug: Recombinant Salmon Calcitonin (rsCT); Drug: Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Apr 2008

First posted22 Feb 2008 (estimated)
Study startFeb 2008
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00620854
Sponsor's protocol ID: UGL-OR0702
Other IDs: Bio-Kinetic No.: 96508
Status last verified: Jan 2012
First submitted: 12 Feb 2008
Last updated: 1 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
ClinicalTrials.gov ID: NCT00620854
Acronym / sponsor ID: UGL-OR0702
Conditions: Osteoporosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Tarsa Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 22 Feb 2008 (estimated)
Results: Posted 24 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
rsCTA	Experimental	Drug: Oral TabletOral Tablet
rsCTB	Experimental	Drug: Oral TabletOral Tablet
Fortical	Active comparator	Drug: Recombinant Salmon Calcitonin (rsCT), Drug: Nasal SprayNasal Spray

Who may qualify

Ages: 45 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Postmenopausal female, in good health (at least 5 years since last menses)
Age ≥45 and ≤70
Weight + or - 20% of the Metropolitan Life weight table
Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL
Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range

Key exclusion criteria (15 listed)

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 non-steroidal anti-inflammatory drugs (NSAID)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant Salmon Calcitonin (rsCT)Also: Fortical® nasal spraySingle dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.	Drug	Fortical
Oral Tablet0.15 mgs recombinant salmon calcitonin, single oral dose	Drug	rsCTA
Oral Tablet0.2mgs recombinant salmon calcitonin, single oral tablet	Drug	rsCTB
Nasal Spray200 IU recombinant salmon calcitonin, single intranasal spray	Drug	Fortical

Primary outcome

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

Results and safety

Results posted to the registry on 24 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rsCTA Then rsCTB Then Fortical	4	4
rsCTA Then Fortical Then rsCTB	4	4
rsCTB Then rsCTA Then Fortical	4	4
rsCTB Then Fortical Then rsCTA	4	4
Fortical Then rsCTA Then rsCTB	4	4
Fortical Then rsCTB Then rsCTA	4	4

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

Time frame: 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. Mean (Standard Error). Unit: % Change in Baseline CTx-1

Measure	rsCT A n = 22	rsCTB n = 22	Fortical® n = 22
Value	-74.17 (2.44)	-71.99 (2.88)	-68.40 (2.80)

Population analysed: Per protocol, only subjects who completed all 3 treatments were analyzed.

Adverse events

Time frame: Adverse Events were collected at each study visit. The three study periods occurred at weekly intervals, so the AE data were collected over a period of 3 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rsCTA Then rsCTB Then Fortical	0 of 4 (0%)	1 of 4 (25%)	Not reported
rsCTA Then Fortical Then rsCTB	0 of 4 (0%)	2 of 4 (50%)	Not reported
rsCTB Then rsCTA Then Fortical	0 of 4 (0%)	1 of 4 (25%)	Not reported
rsCTB Then Fortical Then rsCTA	0 of 4 (0%)	1 of 4 (25%)	Not reported
Fortical Then rsCTA Then rsCTB	0 of 4 (0%)	3 of 4 (75%)	Not reported
Fortical Then rsCTB Then rsCTA	0 of 4 (0%)	3 of 4 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Legg, D.O. principal investigator

Bio-Kinetic Clinical Applications, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Recombinant Salmon Calcitonin (rsCT), Oral Tablet and Nasal Spray in people with Osteoporosis, run by Tarsa Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2012.