This is a Phase 1, double-blind, placebo-controlled, repeated-dose study to assess the safety, tolerability, and preliminary effects of CHI-554 in postmenopausal women ages 50-80 years who have osteopenia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
2
NM Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States
Safety and Tolerability: Adverse Events/Serious Adverse Events
Adverse Events/Serious Adverse Events
Time frame: Week 4
Safety and Tolerability: Adverse Events/Serious Adverse Events
Adverse Events/Serious Adverse Events
Time frame: Week 8
Safety and Tolerability: Adverse Events/Serious Adverse Events
Adverse Events/Serious Adverse Events
Time frame: Week 12
Safety and Tolerability: Alanine aminotransferase (ALT)
Alanine aminotransferase
Time frame: Week 4
Safety and Tolerability: Alanine aminotransferase (ALT)
Alanine aminotransferase
Time frame: Week 12
Safety and Tolerability: Aspartate aminotransferase (AST)
Aspartate aminotransferase
Time frame: Week 4
Safety and Tolerability: Aspartate aminotransferase (AST)
Aspartate aminotransferase
Time frame: Week 12
Safety and Tolerability: Total bilirubin
Total bilirubin
Time frame: Week 4
Safety and Tolerability: Total bilirubin
Total bilirubin
Time frame: Week 12
Safety and Tolerability: Blood pressure
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Blood pressure - Systolic and diastolic blood pressure
Time frame: Week 4
Safety and Tolerability: Blood pressure
Blood pressure - Systolic and diastolic blood pressure
Time frame: Week 12
Safety and Tolerability: Heart rate
Heart rate
Time frame: Week 4
Safety and Tolerability: Heart rate
Heart rate
Time frame: Week 12
Serum CTx
Serum CTx
Time frame: Week 4
Serum CTx
Serum CTx
Time frame: Week 12
Serum P1NP
Serum P1NP
Time frame: Week 4
Serum P1NP
Serum P1NP
Time frame: Week 12
Serum Osteocalcin
Serum Osteocalcin
Time frame: Week 4
Serum Osteocalcin
Serum Osteocalcin
Time frame: Week 12
Serum Bone-specific alkaline phosphatase
Serum Bone-specific alkaline phosphatase
Time frame: Week 4
Serum Bone-specific alkaline phosphatase
Serum Bone-specific alkaline phosphatase
Time frame: Week 12