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

NCT05363020 | Completed Phase 4 DMC

• 1 other identifier: STUDY02001354
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis Hand

Keywords

SAMe; S-Adenosyl-L-Methionine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  Weekly for 17 weeks

• Determine tolerability of SAMe supplementation compared to placebo, as measured by a survey of 14 common symptoms one may experience from a supplement

  Weekly for 17 weeks

Study Arms (2)

S-Adenosyl-L-Methionine (SAMe)

EXPERIMENTAL

Participants receive S-Adenosyl-L-Methionine (SAMe) 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Drug: S-Adenosyl-L-Methionine (Sam-E); Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Drug: S-Adenosyl-L-Methionine (Sam-E); Drug: Placebo

Interventions

S-Adenosyl-L-Methionine (Sam-E) DRUG

400 mg capsule

Placebo; S-Adenosyl-L-Methionine (SAMe)

Placebo DRUG

400 mg identically appearing placebo

Placebo; S-Adenosyl-L-Methionine (SAMe)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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:
• daily opioids (including tramadol or buprenorphine)
• gabapentin or pregabalin
• prednisone
• Prescription NSAIDs that they are unable to stop or topical diclofenac
• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

S-Adenosylmethionine

Intervention Hierarchy (Ancestors)

Methionine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Scott C Jaynes, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Investigator

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: August 17, 2022
• Primary Completion: April 11, 2025
• Study Completion: April 11, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)