OsteopeniaPhase 1NCT05317013
CBD in Postmenopausal Women With Osteopenia
A Phase 1 study testing CBD in people with Osteopenia, run by Canopy Growth Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- CBD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 22 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
NM Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106
About this study
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
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
- Being tested
- CBD, Placebo
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBDDrug
CBD
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A - 100 mg CBD | Experimental | 100 mg CBD per day Receives: Drug: CBD |
| Group B - 300 mg CBD | Experimental | 300 mg CBD per day Receives: Drug: CBD |
| Group C - Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Adverse Events/Serious Adverse Events
Adverse Events/Serious Adverse Events
Measured: Week 4
Safety and Tolerability: Adverse Events/Serious Adverse Events
Adverse Events/Serious Adverse Events
Measured: Week 8
Safety and Tolerability: Adverse Events/Serious Adverse Events
Adverse Events/Serious Adverse Events
Measured: Week 12
Safety and Tolerability: Alanine aminotransferase (ALT)
Alanine aminotransferase
Measured: Week 4
Safety and Tolerability: Alanine aminotransferase (ALT)
Alanine aminotransferase
Measured: Week 12
Safety and Tolerability: Aspartate aminotransferase (AST)
Aspartate aminotransferase
Measured: Week 4
Safety and Tolerability: Aspartate aminotransferase (AST)
Aspartate aminotransferase
Measured: Week 12
Safety and Tolerability: Total bilirubin
Total bilirubin
Measured: Week 4
Safety and Tolerability: Total bilirubin
Total bilirubin
Measured: Week 12
Safety and Tolerability: Blood pressure
Blood pressure - Systolic and diastolic blood pressure
Measured: Week 4
Safety and Tolerability: Blood pressure
Blood pressure - Systolic and diastolic blood pressure
Measured: Week 12
Safety and Tolerability: Heart rate
Heart rate
Measured: Week 4
Safety and Tolerability: Heart rate
Heart rate
Measured: Week 12
Secondary outcomes (8)
Serum CTx
Serum CTx
Measured: Week 4
Serum CTx
Serum CTx
Measured: Week 12
Serum P1NP
Serum P1NP
Measured: Week 4
Serum P1NP
Serum P1NP
Measured: Week 12
Serum Osteocalcin
Serum Osteocalcin
Measured: Week 4
Serum Osteocalcin
Serum Osteocalcin
Measured: Week 12
Serum Bone-specific alkaline phosphatase
Serum Bone-specific alkaline phosphatase
Measured: Week 4
Serum Bone-specific alkaline phosphatase
Serum Bone-specific alkaline phosphatase
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 May 2022
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canopy Growth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NM Clinical Research & Osteoporosis Center, Inc.
- Responsible party
- Sponsor
- Investigators
- Lance Rudolph, MD, Principal investigator, NM Clinical Research & Osteoporosis Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317013
- Sponsor's protocol ID
- 710022US1314
- Status last verified
- Sep 2022
- First submitted
- 21 Mar 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05317013
- Acronym / sponsor ID
- 710022US1314
- Conditions
- Osteopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Canopy Growth CorporationIndustry (pharma, biotech, devices)
- Collaborators
- NM Clinical Research & Osteoporosis Center, Inc.
- Study start
- 1 May 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - 100 mg CBD | Experimental | Drug: CBD100 mg CBD per day |
| Group B - 300 mg CBD | Experimental | Drug: CBD300 mg CBD per day |
| Group C - Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBDCBD | Drug | Group A - 100 mg CBD, Group B - 300 mg CBD |
| PlaceboPlacebo | Other | Group C - Placebo |
Primary outcome
Safety and Tolerability: Adverse Events/Serious Adverse Events
Time frame: Week 4
Adverse Events/Serious Adverse Events
Safety and Tolerability: Adverse Events/Serious Adverse Events
Time frame: Week 8
Adverse Events/Serious Adverse Events
Safety and Tolerability: Adverse Events/Serious Adverse Events
Time frame: Week 12
Adverse Events/Serious Adverse Events
Safety and Tolerability: Alanine aminotransferase (ALT)
Time frame: Week 4
Alanine aminotransferase
Safety and Tolerability: Alanine aminotransferase (ALT)
Time frame: Week 12
Alanine aminotransferase
Safety and Tolerability: Aspartate aminotransferase (AST)
Time frame: Week 4
Aspartate aminotransferase
Safety and Tolerability: Aspartate aminotransferase (AST)
Time frame: Week 12
Aspartate aminotransferase
Safety and Tolerability: Total bilirubin
Time frame: Week 4
Total bilirubin
Safety and Tolerability: Total bilirubin
Time frame: Week 12
Total bilirubin
Safety and Tolerability: Blood pressure
Time frame: Week 4
Blood pressure - Systolic and diastolic blood pressure
Safety and Tolerability: Blood pressure
Time frame: Week 12
Blood pressure - Systolic and diastolic blood pressure
Safety and Tolerability: Heart rate
Time frame: Week 4
Heart rate
Safety and Tolerability: Heart rate
Time frame: Week 12
Heart rate
8 secondary outcomes
Serum CTx
Time frame: Week 4
Serum CTx
Time frame: Week 12
Serum P1NP
Time frame: Week 4
Serum P1NP
Time frame: Week 12
Serum Osteocalcin
Time frame: Week 4
Serum Osteocalcin
Time frame: Week 12
Serum Bone-specific alkaline phosphatase
Time frame: Week 4
Serum Bone-specific alkaline phosphatase
Time frame: Week 12
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lance Rudolph, MD principal investigator
NM Clinical Research & Osteoporosis Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBD in people with Osteopenia, run by Canopy Growth Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: Adverse Events/Serious Adverse Events (time frame: Week 4). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.