S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands

Osteoarthritis Hand Clinical Trial

— SAMe  

Official title:

S-Adenosyl-L-Methionine (SAMe) vs Placebo for Discomfort and Functional Limitations Associated With Osteoarthritis of the Hands: a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05363020
• Other study ID #: STUDY02001354
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 17, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to demonstrate the feasibility of evaluating SAMe tolerability, analgesic benefits, and daily functional improvement in patients with osteoarthritis of the hands compared to placebo. The secondary objective of this study is to generate preliminary data on discomfort, function, quality of life in patients with osteoarthritis of the hands when taking SAMe compared to placebo.

Description:

At week 0, all patients giving written informed consent and meeting eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to SAMe (400mg orally, twice daily) or placebo (400mg, twice daily) for 8 weeks. Followed by a one week wash out period followed by another 8 weeks of SAMe (400mg, twice daily) or placebo (400mg, twice daily) for 8 weeks (whichever was not given during the first 8 week period).

Participants will complete weekly surveys during the entire study regarding hand discomfort, functional limitations and side effects

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Current primary care provider within the Dartmouth Health system

• Office visit at Dartmouth Health in the past 3 years

• Participants must be 40 or older at the time of signing the informed consent

• Participants have discomfort or functional limitations of one or both hands AND either:

1. Objective findings of at least one hand meeting diagnostic criteria based on the American College of Rheumatology (ACR)* or

2. Existing radiographic evidence of osteoarthritis as judged by a radiologist

• Patients taking OTC or prescription analgesics who are willing to stop their current analgesics for two weeks prior to study entry and remain off those medications over the course of the study

• *Objective inclusion criteria (see poster schematic)

Swelling or deformity of 2 of the following ten joints: the 2nd and 3rd distal interphalangeal (DIP) of each hand, the 2nd and 3rd proximal interphalangeal (PIP) of each hand, and the 1st carpometacarpal joints of both hands.

Exclusion Criteria:

• Patients taking prescription medications other than NSAIDs for their OA who are unable to stop their medication

• Patients with diagnoses of arthritis from conditions other than OA

• Patients whose symptomatic joint is an artificial joint

• Patients with Bipolar Disorder

• Patients taking any of the following medications at study entry OR starting any of these medications during the study period:

1. daily opioids (including tramadol or buprenorphine)

2. gabapentin or pregabalin

3. prednisone

4. Prescription NSAIDs that they are unable to stop or topical diclofenac

5. SNRI drugs (Effexor, Cymbalta, Fetzima, Pristiq)

• The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Hand

Intervention

Drug:
• S-Adenosyl-L-Methionine (Sam-E)
400 mg capsule
• Placebo
400 mg identically appearing placebo

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the effect of SAMe supplements on hand discomfort relative to placebo, as measured by the change in discomfort scores over time on a visual analog scale	Scores range from 0-10, 0 being no discomfort and 10 being maximum discomfort	Weekly for 17 weeks
Secondary	Determine the effect of SAMe supplementation on quality of life measures regarding hand arthritis, as measured by DASH (Disability of Arm, Shoulder and Hand) survey responses done weekly for 17 weeks	Survey using descriptors of disability and function ranging from no disability to complete disability with 3 other levels of disability in between done weekly for 17 weeks	Weekly for 17 weeks
Secondary	Determine tolerability of SAMe supplementation compared to placebo, as measured by a survey of 14 common symptoms one may experience from a supplement	14 symptoms queried for occurrence over the week ranging from "Not at All" to "Very Much" with three additional options in between	Weekly for 17 weeks