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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT00620854 (opens ClinicalTrials.gov in a new tab)Other idUGL-OR0702Other idBio-Kinetic No.: 96508
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
24 participants (actual)
Sponsor
Tarsa Therapeutics, Inc. · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Feb 2008
Primary completion
Apr 2008
Completion
Apr 2008
First posted
22 Feb 2008 (estimated)
Last update posted
1 Feb 2012 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20082009
  1. Ph 2

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

    NCT00620854

    Feb 2008 to Apr 2008

Registry summary

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

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

Interventions

  • Recombinant Salmon Calcitonin (rsCT)Drug
  • Oral TabletDrug
  • Oral TabletDrug
  • Nasal SprayDrug

Arms3

  • Experimental

    rsCTA

    Oral Tablet

  • Experimental

    rsCTB

    Oral Tablet

  • Active comparator

    Fortical

    Nasal Spray

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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.

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· 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

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

GroupValue (% Change in Baseline CTx-1)Spread
rsCT A-74.172.44
rsCTB-71.992.88
Fortical®-68.402.80

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
rsCTA Then rsCTB Then Forticalsingle dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)–0 / 41 / 4
rsCTA Then Fortical Then rsCTBsingle dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)–0 / 42 / 4
rsCTB Then rsCTA Then Forticalsingle dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)–0 / 41 / 4
rsCTB Then Fortical Then rsCTAsingle dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)–0 / 41 / 4
Fortical Then rsCTA Then rsCTBsingle dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)–0 / 43 / 4
Fortical Then rsCTB Then rsCTAsingle dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)–0 / 43 / 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 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 * 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 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 non-steroidal anti-inflammatory drugs (NSAID) * History of surgery within 60 days of enrollment * 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

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