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Cannabinoid
CBD for Osteopenia
Phase 1
Waitlist Available
Led By Lance Rudolph, MD
Research Sponsored by Canopy Growth Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is a female aged 50-80 years, inclusive, at the time of screening.
Is postmenopausal, defined as > or = 12 months amenorrhoea.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
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.
Eligible Conditions
- Osteopenia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability: Adverse Events/Serious Adverse Events
Safety and Tolerability: Alanine aminotransferase (ALT)
Safety and Tolerability: Aspartate aminotransferase (AST)
+3 moreSecondary outcome measures
Serum Bone-specific alkaline phosphatase
Serum CTx
Serum Osteocalcin
+1 moreSide effects data
From 2014 Phase 2 trial • 50 Patients • NCT018446872%
headache
2%
Blurred Vision
2%
Cold Symptoms
2%
Gastrointestinal Upset
2%
anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active MJ With 0 mg CBD
Active MJ With 200 mg CBD
Active MJ With 400 mg CBD
Active MJ With 800 mg CBD
Inactive MJ With 0 mg CBD
Inactive MJ With 200 mg CBD
Inactive MJ With 400 mg CBD
Inactive MJ With 800 mg CBD
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Group B - 300 mg CBDExperimental Treatment1 Intervention
300 mg CBD per day
Group II: Group A - 100 mg CBDExperimental Treatment1 Intervention
100 mg CBD per day
Group III: Group C - PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBD
2016
Completed Phase 2
~440
Find a Location
Who is running the clinical trial?
NM Clinical Research & Osteoporosis Center, Inc.UNKNOWN
Canopy Growth CorporationLead Sponsor
13 Previous Clinical Trials
1,152 Total Patients Enrolled
Lance Rudolph, MDPrincipal InvestigatorNM Clinical Research & Osteoporosis Center, Inc.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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