Clinical trial NCT05317013: CBD in Postmenopausal Women With Osteopenia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Osteopenia
Lead sponsor: Canopy Growth Corporation
Sponsor class: INDUSTRY
Collaborators: name: NM Clinical Research & Osteoporosis Center, Inc.
First posted: 2022-04-07
Enrollment: 2
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Tolerability: Adverse Events/Serious Adverse Events
timeFrame: Week 4
measure: Safety and Tolerability: Adverse Events/Serious Adverse Events
timeFrame: Week 8
measure: Safety and Tolerability: Adverse Events/Serious Adverse Events
timeFrame: Week 12
measure: Safety and Tolerability: Alanine aminotransferase (ALT)
timeFrame: Week 4
measure: Safety and Tolerability: Alanine aminotransferase (ALT)
timeFrame: Week 12
measure: Safety and Tolerability: Aspartate aminotransferase (AST)
timeFrame: Week 4
measure: Safety and Tolerability: Aspartate aminotransferase (AST)
timeFrame: Week 12
measure: Safety and Tolerability: Total bilirubin
timeFrame: Week 4
measure: Safety and Tolerability: Total bilirubin
timeFrame: Week 12
measure: Safety and Tolerability: Blood pressure
timeFrame: Week 4
measure: Safety and Tolerability: Blood pressure
timeFrame: Week 12
measure: Safety and Tolerability: Heart rate
timeFrame: Week 4
measure: Safety and Tolerability: Heart rate
timeFrame: Week 12
Secondary outcomes:
measure: Serum CTx
timeFrame: Week 4
measure: Serum CTx
timeFrame: Week 12
measure: Serum P1NP
timeFrame: Week 4
measure: Serum P1NP
timeFrame: Week 12
measure: Serum Osteocalcin
timeFrame: Week 4
measure: Serum Osteocalcin
timeFrame: Week 12
measure: Serum Bone-specific alkaline phosphatase
timeFrame: Week 4
measure: Serum Bone-specific alkaline phosphatase
timeFrame: Week 12
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: NM Clinical Research & Osteoporosis Center, Inc.
state: New Mexico
Study officials:
affiliation: NM Clinical Research & Osteoporosis Center, Inc.
name: Lance Rudolph, MD
role: PRINCIPAL_INVESTIGATOR
References: