A Study of Oral Calcitonin Given at Night to Healthy Postmenopausal Women

Tarsa Therapeutics

Status and phase: Completed; Phase 2

Conditions: Phase 1 Pharmacodynamic Study

Treatments: Drug: Fortical (rsCT) nasal spray; Drug: Oral rsCT tablet; Drug: Oral Placebo Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803686

Bio-Kinetic No.: 13808 (Other Identifier)

UGL-OR0803

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 4 patient groups, including a placebo group

Part 1 Double Blind Oral rsCT Tablet

Experimental group

Description:

Intervention: Oral rsCT tablet given once 4 hours after evening meal.

Treatment:

Drug: Oral rsCT tablet

Drug: Oral rsCT tablet

Part 1, Double-blind Oral Placebo Tablet

Placebo Comparator group

Description:

Intervention: Oral placebo tablet matching the oral rsCT tablet, given once 4 hours after evening meal

Treatment:

Drug: Oral Placebo Tablet

Part 2 Open label, Oral rsCT tablet

Experimental group

Description:

Intervention: Oral rsCT tablet given once 2 hours after evening meal.

Treatment:

Drug: Oral rsCT tablet

Drug: Oral rsCT tablet

Part 2, Open Label Fortical Nasal Spray

Active Comparator group

Description:

Intervention: Part 2 Open label. Fortical (rsCT) nasal spray given once 2 hours after evening meal

Treatment:

Drug: Fortical (rsCT) nasal spray