CBD in Postmenopausal Women With Osteopenia

Osteopenia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Repeated-Dose Study to Assess the Safety, Tolerability, and Preliminary Effects of CHI-554 in Postmenopausal Women With Osteopenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05317013
• Other study ID #: 710022US1314
• Status: Terminated
• Phase: Phase 1
• Start date: May 1, 2022
• Est. completion date: September 22, 2022

Study information

• Verified date: September 2022
• Source: Canopy Growth Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 22, 2022
• Est. primary completion date: September 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Is a female aged 50-80 years, inclusive, at the time of screening.

• Is postmenopausal, defined as > or = 12 months amenorrhoea.

• Has osteopenia, defined as T score at lumbar spine or femoral neck or total femur of less than -1.0, but not less than or equal to -2.5, according to dual energy x-ray absorptiometry (DXA) completed at the Screening Visit or performed at NM Clinical Research & Osteoporosis Center up to 6 months prior to the Screening Visit.

• Has been on a stable dose of 500 mg calcium daily for at least 7 days prior to Visit 1.

• Has a body mass index between 18 and 35 kg/m2 (inclusive).

• Is judged by the Investigator to be in generally good health at screening based on participants' medical history.

• Must be adequately informed of the nature and risks of the study and give written informed consent prior to screening.

Exclusion Criteria:

• Has a history of epilepsy, hepatitis, or human immunodeficiency virus.

• Current or history of use of one or more prohibited medications (as described in Section 8.2.1.1).

• Changes in the use of a prescription, over-the-counter (OTC), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the 4 weeks prior to the Screening Visit.

• Evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of normal (ULN), or bilirubin >2× ULN.

• Has any clinically significant condition or abnormal finding at screening that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study IP.

• Has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the IP (e.g., coconut; coconut oil; medium-chain triglycerides).

• Has taken grapefruit products and/or Seville oranges within the 7 days prior to Visit 1.

• Positive urine dipstick results for THC at the Screening Visit.

• Has a history or current diagnosis of a significant psychiatric disorder, including alcohol or substance use disorder, that would, in the opinion of the Investigator, affect the subject's ability to comply with the study requirements.

• Has participated in any investigational product or device study within 30 days prior to the Screening Visit, or is scheduled to participate in another investigational product or device study during the course of this study.

• Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.

• History of Osteoporosis diagnosis.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Drug:
• CBD
CBD

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	NM Clinical Research & Osteoporosis Center, Inc.	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Canopy Growth Corporation	NM Clinical Research & Osteoporosis Center, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability: Adverse Events/Serious Adverse Events	Adverse Events/Serious Adverse Events	Week 4
Primary	Safety and Tolerability: Adverse Events/Serious Adverse Events	Adverse Events/Serious Adverse Events	Week 8
Primary	Safety and Tolerability: Adverse Events/Serious Adverse Events	Adverse Events/Serious Adverse Events	Week 12
Primary	Safety and Tolerability: Alanine aminotransferase (ALT)	Alanine aminotransferase	Week 4
Primary	Safety and Tolerability: Alanine aminotransferase (ALT)	Alanine aminotransferase	Week 12
Primary	Safety and Tolerability: Aspartate aminotransferase (AST)	Aspartate aminotransferase	Week 4
Primary	Safety and Tolerability: Aspartate aminotransferase (AST)	Aspartate aminotransferase	Week 12
Primary	Safety and Tolerability: Total bilirubin	Total bilirubin	Week 4
Primary	Safety and Tolerability: Total bilirubin	Total bilirubin	Week 12
Primary	Safety and Tolerability: Blood pressure	Blood pressure - Systolic and diastolic blood pressure	Week 4
Primary	Safety and Tolerability: Blood pressure	Blood pressure - Systolic and diastolic blood pressure	Week 12
Primary	Safety and Tolerability: Heart rate	Heart rate	Week 4
Primary	Safety and Tolerability: Heart rate	Heart rate	Week 12
Secondary	Serum CTx	Serum CTx	Week 4
Secondary	Serum CTx	Serum CTx	Week 12
Secondary	Serum P1NP	Serum P1NP	Week 4
Secondary	Serum P1NP	Serum P1NP	Week 12
Secondary	Serum Osteocalcin	Serum Osteocalcin	Week 4
Secondary	Serum Osteocalcin	Serum Osteocalcin	Week 12
Secondary	Serum Bone-specific alkaline phosphatase	Serum Bone-specific alkaline phosphatase	Week 4
Secondary	Serum Bone-specific alkaline phosphatase	Serum Bone-specific alkaline phosphatase	Week 12