CBD in Postmenopausal Women With Osteopenia

NCT05317013 | Terminated Phase 1 FDA Drug

• 1 other identifier: 710022US1314
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (8)

• Serum CTx

  Week 4

• Serum CTx

  Week 12

• Serum P1NP

  Week 4

• Serum P1NP

  Week 12

• Serum Osteocalcin

  Week 4

Study Arms (3)

Group A - 100 mg CBD

EXPERIMENTAL

100 mg CBD per day

Drug: CBD

Group B - 300 mg CBD

EXPERIMENTAL

300 mg CBD per day

Drug: CBD

Group C - Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CBD DRUG

CBD

Group A - 100 mg CBD; Group B - 300 mg CBD

Placebo OTHER

Placebo

Group C - Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canopy Growth Corporation: lead
• NM Clinical Research & Osteoporosis Center, Inc.: collaborator

Study Sites (1)

NM Clinical Research & Osteoporosis Center, Inc.

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lance Rudolph, MD

  NM Clinical Research & Osteoporosis Center, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 7, 2022
• Study Start: May 1, 2022
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

US (1)