Phase 2
Completed N=12
A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women
Phase 1 Pharmacodynamic Study
Source: ClinicalTrials.gov NCT00803686 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Pharmacodynamic Effect of Oral Calcitonin — 37.5; 100; 41.2; 44.4 percentage of time-matched placebo respo
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacodynamic Effect of Oral Calcitonin |
37.5; 100; 41.2; 44.4 | — |
| SECONDARY Derived Pharmacodynamic Parameters Further Characterizing the Effects of Oral or Intranasal Calcitonin on Plasma CTx-1, Given at Night to Post-menopausal Women |
7.5; 0; 4.5; 4.0; 10.9; 0 | — |
| SECONDARY AUCInhibition=Hours*%P |
474.7; 0; 345.8; 504.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00803686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.