CBD in Postmenopausal Women With Osteopenia

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

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 Overview

• Status: Terminated
• Conditions: Osteopenia
• Intervention / Treatment: Other: Placebo; Drug: CBD

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • NM Clinical Research & Osteoporosis Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A - 100 mg CBD; 100 mg CBD per day	Drug: CBD; CBD
EXPERIMENTAL: Group B - 300 mg CBD; 300 mg CBD per day	Drug: CBD; CBD
PLACEBO_COMPARATOR: Group C - Placebo; Placebo	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability: Adverse Events/Serious Adverse Events	Adverse Events/Serious Adverse Events	Week 4
Safety and Tolerability: Adverse Events/Serious Adverse Events	Adverse Events/Serious Adverse Events	Week 8
Safety and Tolerability: Adverse Events/Serious Adverse Events	Adverse Events/Serious Adverse Events	Week 12
Safety and Tolerability: Alanine aminotransferase (ALT)	Alanine aminotransferase	Week 4
Safety and Tolerability: Alanine aminotransferase (ALT)	Alanine aminotransferase	Week 12
Safety and Tolerability: Aspartate aminotransferase (AST)	Aspartate aminotransferase	Week 4
Safety and Tolerability: Aspartate aminotransferase (AST)	Aspartate aminotransferase	Week 12
Safety and Tolerability: Total bilirubin	Total bilirubin	Week 4
Safety and Tolerability: Total bilirubin	Total bilirubin	Week 12
Safety and Tolerability: Blood pressure	Blood pressure - Systolic and diastolic blood pressure	Week 4
Safety and Tolerability: Blood pressure	Blood pressure - Systolic and diastolic blood pressure	Week 12
Safety and Tolerability: Heart rate	Heart rate	Week 4
Safety and Tolerability: Heart rate	Heart rate	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum CTx	Serum CTx	Week 4
Serum CTx	Serum CTx	Week 12
Serum P1NP	Serum P1NP	Week 4
Serum P1NP	Serum P1NP	Week 12
Serum Osteocalcin	Serum Osteocalcin	Week 4
Serum Osteocalcin	Serum Osteocalcin	Week 12
Serum Bone-specific alkaline phosphatase	Serum Bone-specific alkaline phosphatase	Week 4
Serum Bone-specific alkaline phosphatase	Serum Bone-specific alkaline phosphatase	Week 12

Collaborators and Investigators

• Sponsor: Canopy Growth Corporation
• Collaborators: NM Clinical Research & Osteoporosis Center, Inc.
• Investigators: Principal Investigator: Lance Rudolph, MD, NM Clinical Research & Osteoporosis Center, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2022
• Primary Completion (ACTUAL): September 22, 2022
• Study Completion (ACTUAL): September 22, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (ACTUAL): April 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: 710022US1314

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No