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TerminatedNCT05317013Updated Sep 23, 2022

CBD in Postmenopausal Women With Osteopenia

A Phase 1 interventional study of CBD and Placebo in Osteopenia, sponsored by Canopy Growth Corporation. Terminated at 1 site in United States. Open to female participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-23.

Sponsored by Canopy Growth Corporation · Phase 1, Interventional, and Supportive care

Why this study was terminated
Low enrollment

From the registry’s dates

  • Primary completion was Sep 2022, 4 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Osteopenia
03

In context

Bone Diseases, Metabolic

470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.

This study's enrollment of 2 is below the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.

Browse Bone Diseases, Metabolic studies →

Lead sponsor

Canopy Growth Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Group A - 100 mg CBD

    100 mg CBD per day

    Drug: CBD

  • Experimental
    Group B - 300 mg CBD

    300 mg CBD per day

    Drug: CBD

  • Placebo comparator
    Group C - Placebo

    Placebo

    Other: Placebo

Interventions

  • DrugCBD

    CBD

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability: Adverse Events/Serious Adverse Events

    Adverse Events/Serious Adverse Events

    Time frame: Week 4

  2. Safety and Tolerability: Adverse Events/Serious Adverse Events

    Adverse Events/Serious Adverse Events

    Time frame: Week 8

  3. Safety and Tolerability: Adverse Events/Serious Adverse Events

    Adverse Events/Serious Adverse Events

    Time frame: Week 12

  4. Safety and Tolerability: Alanine aminotransferase (ALT)

    Alanine aminotransferase

    Time frame: Week 4

  5. Safety and Tolerability: Alanine aminotransferase (ALT)

    Alanine aminotransferase

    Time frame: Week 12

  6. Safety and Tolerability: Aspartate aminotransferase (AST)

    Aspartate aminotransferase

    Time frame: Week 4

  7. Safety and Tolerability: Aspartate aminotransferase (AST)

    Aspartate aminotransferase

    Time frame: Week 12

  8. Safety and Tolerability: Total bilirubin

    Total bilirubin

    Time frame: Week 4

  9. Safety and Tolerability: Total bilirubin

    Total bilirubin

    Time frame: Week 12

  10. Safety and Tolerability: Blood pressure

    Blood pressure - Systolic and diastolic blood pressure

    Time frame: Week 4

  11. Safety and Tolerability: Blood pressure

    Blood pressure - Systolic and diastolic blood pressure

    Time frame: Week 12

  12. Safety and Tolerability: Heart rate

    Heart rate

    Time frame: Week 4

  13. Safety and Tolerability: Heart rate

    Heart rate

    Time frame: Week 12

Secondary outcomes

  1. Serum CTx

    Serum CTx

    Time frame: Week 4

  2. Serum CTx

    Serum CTx

    Time frame: Week 12

  3. Serum P1NP

    Serum P1NP

    Time frame: Week 4

  4. Serum P1NP

    Serum P1NP

    Time frame: Week 12

  5. Serum Osteocalcin

    Serum Osteocalcin

    Time frame: Week 4

  6. Serum Osteocalcin

    Serum Osteocalcin

    Time frame: Week 12

  7. Serum Bone-specific alkaline phosphatase

    Serum Bone-specific alkaline phosphatase

    Time frame: Week 4

  8. Serum Bone-specific alkaline phosphatase

    Serum Bone-specific alkaline phosphatase

    Time frame: Week 12

07

Study locations

1 site
  • NM Clinical Research & Osteoporosis Center, Inc.
    Albuquerque, New Mexico 87106, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05317013
Lead sponsor
Canopy Growth Corporation
Collaborators
NM Clinical Research & Osteoporosis Center, Inc.
Responsible party
Sponsor
First posted
Apr 7, 2022
Start date
May 1, 2022
Primary completion
Sep 22, 2022
Completion
Sep 22, 2022
Last update
Sep 23, 2022

Study contacts

Lance Rudolph, MD
principal investigator · NM Clinical Research & Osteoporosis Center, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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