Clinical trial NCT00803686: A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women
Official title: A Randomized, Open-Label, Placebo-Controlled, Two-Period Crossover Study of the Effect on CTx-1 Concentrations of a Single 200 μg Recombinant Salmon Calcitonin (rsCT) Dose Given at Night to Normal, Healthy, Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Phase 1 Pharmacodynamic Study
Lead sponsor: Tarsa Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-05
Enrollment: 12
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacodynamic Effect of Oral Calcitonin
timeFrame: 12 hr
Secondary outcomes:
measure: Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women
timeFrame: 12 hours
measure: AUCInhibition=Hours*%P
timeFrame: 12 Hours
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, Inc.
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications, Inc.
name: Thomas Legg, D.O.
role: PRINCIPAL_INVESTIGATOR
References: