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

Tarsa Therapeutics

Status and phase: Completed; Phase 2

Conditions: Osteoporosis

Treatments: Drug: Recombinant Salmon Calcitonin (rsCT); Drug: Nasal Spray; Drug: Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620854

Bio-Kinetic No.: 96508

UGL-OR0702

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Female

Ages: 45 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

rsCTA

Experimental group

Description:

Oral Tablet

Treatment:

Drug: Oral Tablet

Drug: Oral Tablet

rsCTB

Experimental group

Description:

Oral Tablet

Treatment:

Drug: Oral Tablet

Drug: Oral Tablet

Fortical

Active Comparator group

Description:

Nasal Spray

Treatment:

Drug: Nasal Spray

Drug: Recombinant Salmon Calcitonin (rsCT)