Clinical trial NCT00536302: A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA)
Official title: A Single Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Pilot Clinical Trial to Evaluate the Sensitivity of Magnetic Resonance Imaging to Detect Change in Cartilage Structure and Composition in 30 Participants Diagnosed With Osteoarthritis of the Knee and Treated With Collagen Hydrolysate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Knee Osteoarthritis (OA)
Keywords: OA
Knee arthritis
Osteoarthritis
Nutritional supplement
CAM
MRI
Lead sponsor: GELITA
Sponsor class: INDUSTRY
First posted: 2007-09-27
Enrollment: 30
Sex: ALL
Minimum age (years): 49
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and 48.

Detailed description: This is a single-site, double-blind, pilot study to evaluate the sensitivity of MRI to detect cartilage structure and composition in subjects taking daily oral collagen hydrolysate (a nutritional supplement) or placebo for 48 weeks. 30 subjects will be randomized to collagen hydrolysate or placebo (1:1 ratio). The goal is to evaluate, by MRI, knee cartilage and structure in all subjects. The primary functional outcome measure will be the WOMAC questionnaire and the primary pathological outcome measure will be knee cartilage structure and composition as measurements done by MRI imaging. Subjects will have contrast dGEMRIC MRIs done at Study Weeks -1, 24 and 48.

Eligibility criteria: Inclusion Criteria:

* age \> 49 years
* chronic knee discomfort based on the affirmative response to the question "During the past 6 months, have you had any pain in the knee more than half the days of the month ?"
* WOMAC pain subscale score ≥ 1
* tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
* clinical examination confirming knee pain or discomfort referable to the knee joint
* prepared to refrain from use of glucosamine, chondroitin, sAME and doxycycline
* stable medication and/or supplement use

Exclusion Criteria:

* use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
* serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
* individuals who are expected not to comply with the study protocol
* plan to permanently relocate from the region during the trial period
* planned knee arthroplasty in the study knee
* active pathology of confounding origin which may cause pain, extending to the knee
* pregnancy
* any contra-indication to having an MRI scan

Primary outcomes:
measure: To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.
timeFrame: 48 Weeks
Secondary outcomes:
measure: To measure knee cartilage volume over 48 weeks at three time points.
timeFrame: 48 Weeks
measure: To measure and evaluate WOMAC pain subscale scores over 48 weeks.
timeFrame: 48 Weeks
measure: To evaluate change in physical function tests over 48 weeks.
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center; Center for Arthritis and Rheumatic Diseases
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center; Center for Arthritis and Rheumatic Diseases
name: Timothy E McAlindon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: McAlindon T, Bartnik E, S Ried J, Teichert L, Herrmann M, Flechsenhar K. Determination of serum biomarkers in osteoarthritis patients: a previous interventional imaging study revisited. J Biomed Res. 2016 Oct 17;31(1):25-30. doi: 10.7555/JBR.31.20150167.