Osteoporosis
Conditions
Brief summary
This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).
Interventions
DRUGRecombinant Salmon Calcitonin (rsCT)
Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4.
DRUGOral Tablet
0.15 mgs recombinant salmon calcitonin, single oral dose
DRUGNasal Spray
200 IU recombinant salmon calcitonin, single intranasal spray
Sponsors
Tarsa Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline) | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the study site data base during January 2008.
Participants by arm
| Arm | Count |
|---|---|
| rsCTA Then rsCTB Then Fortical single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 4 |
| rsCTA Then Fortical Then rsCTB single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 4 |
| rsCTB Then rsCTA Then Fortical single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 4 |
| rsCTB Then Fortical Then rsCTA single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 4 |
| Fortical Then rsCTA Then rsCTB single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 4 |
| Fortical Then rsCTB Then rsCTA single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU) | 4 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Washout 1 | Withdrawal by Subject | 0 | 0 | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | rsCTA Then rsCTB Then Fortical | rsCTA Then Fortical Then rsCTB | rsCTB Then rsCTA Then Fortical | rsCTB Then Fortical Then rsCTA | Fortical Then rsCTA Then rsCTB | Fortical Then rsCTB Then rsCTA | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 2 Participants | 3 Participants | 4 Participants | 4 Participants | 4 Participants | 21 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 4 participants | 4 participants | 4 participants | 4 participants | 24 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 4 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 4 | 2 / 4 | 1 / 4 | 1 / 4 | 3 / 4 | 3 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
Primary
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.
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
Population: Per protocol, only subjects who completed all 3 treatments were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| rsCT A | Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline) | -74.17 % Change in Baseline CTx-1 | Standard Error 2.44 |
| rsCTB | Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline) | -71.99 % Change in Baseline CTx-1 | Standard Error 2.88 |
| Fortical® | Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline) | -68.40 % Change in Baseline CTx-1 | Standard Error 2.8 |