Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Glucosamine and Chondroitin Supplementation in Women With Knee Osteoarthritis Participating in an Exercise and Weight Loss Program: a Randomized Placebo Controlled Clinical Trial
Brief Summary: Background: Exercise, weight loss, and dietary supplementation of glucosamine and chondroitin (GC) have been reported to improve functional capacity in individuals with knee osteoarthritis (OA). The purpose of this study was 1.) to determine whether women with knee OA who follow a higher protein diet observe more favorable changes in body composition and/or markers of health compared to those following a standard higher carbohydrate-based diet; and, 2.) to determine whether dietary supplementation of glucosamine and chondroitin during a weight loss and fitness program lessens symptoms of pain, improves functional capacity, and/or promotes greater health benefits in women with knee OA. It was hypothesized that both groups would experience beneficial changes in body mass, body composition, and markers of health. However, greater benefits would be observed in those following a higher protein diet while supplementing the diet with glucosamine and chondroitin.


Options:
A: Inclusion Criteria:

* Patients of either sex
* Aged 40 and over
* Outpatients
* Patients fulfilling the American Congress of Rheumatology (ACR) criteria for the reporting of hand OA
* Patients showing X-ray features of hand OA on at least two joints (2 IP and/or 1 IP and 1 TMC) of the dominant hand on standard plain radiographs (\< 6 month).
* Suffering from regular spontaneous pain on the dominant hand (VAS \> or = 40 mm at inclusion time).
* Showing a FIHOA score \> or = 6.
* Having had at least two painful flares in a finger joint during the previous 12 month.
* Patients who have signed the written informed consent for their participation in the study
* Patients able to understand and follow the protocol.
* Patients with a satisfying health and nutritional status.
* Female subjects of childbearing potential using, within three months prior to the inclusion in the study, a reliable form of contraception during the course of the study (oral contraceptive pill, intrauterine device or condoms) or female of non childbearing potential (hysterectomy, bilateral ovariectomy or tubal section/ligation).
* Female subjects of childbearing potential with a negative urinary pregnancy test before the inclusion in the study.

Exclusion Criteria:

* Inflammatory joint disease of other origin
* Septic arthritis
* Chronic inflammatory joint disease
* Previous articular fracture of the concerned articulations
* Use of analgesic therapy for other indications
* Receiving oral corticosteroids
* Mono-articular posttraumatic OA of the finger
* Planning surgery of the hands in the following 6 months
* Patients suffering or having suffered from secondary osteoarthritis after one of the following diseases:

  * Infectious arthritis - Acromegaly
  * Ochronosis - Hemachromatosis
  * Gout - Wilson's disease
  * Chondrocalcinosis - Paget's disease
  * Osteochondrosis - Mutation of collagen
  * Genetic problems (for ex. hypermobility) - Previous joint fracture
  * Arthropathies of different aetiologies - Algodystrophy (M. Sudeck)
* Congenital abnormalities
* Recurrent pseudogout
* Major dysplasias
* Intra-articular injection in a hand joint from less than 3 months
* Basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerhein, hyaluronic acid) in the last 3 months
* Articular lavage in the last 3 months
* Treatment with corticoids, by any administration route during the last month
* Patient suffering from frequent asthma crises
* Physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) on the hands foreseeable in the next year
* Serious organic diseases: heart failure, renal or hepatic insufficiency, blood dyscrasia, serious infection
* Participation in other clinical trials in the two months preceding the study
* Known or ascertained hypersensitivity to the active ingredient of the tested drug.
* Patients refusing to sign the written informed consent form
* Patients who do not co-operate, not respecting the protocol requirements
* Pregnant or lactating women
B: Inclusion Criteria:

- General entrance criteria included being a female with physician diagnosed OA between the ages of 18-70 years with a body mass index (BMI) \> 27 kg/m2 and no recent participation in a diet or exercise program.

Exclusion Criteria:

- Subjects were not allowed to participate in this study if they: 1.) were pregnant, became pregnant, or had a desire for pregnancy; 2.) had any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; 3.) had a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease; were taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications; 4.) had taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (e.g., DHEA), or weight loss supplements (e.g., thermogenics) within three months prior to the start of the study; 5.) were ingesting any anti-inflammatory products two weeks before the start of the study or additional products during the study; 6.) reported any unusual adverse events associated with this study in which the supervising physician recommended removal from the study; 7.) had significant injury or surgery to the lower extremity or spine within the last six months; 8.) did not indicate a minimal amount of perceived pain and physical function limitation on inventories used in the study; 9.) had severe arthritis that required surgery and greatly limited functionality (inability to perform lunge); or, 10.) had arthritis that required the current use of physiotherapy modalities.
C: Inclusion Criteria:

* Primary knee OA according to ACR criteria;
* OA of radiological stages 1 to 3 according to Kellgren-Lawrence;
* VAS of pain ≥30;
* PASI ≥ 5.

Exclusion Criteria:

* Known allergy to chondroitin sulphate;
* Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis, Wilson's disease;
* Patients with skin conditions that could interfere in the clinical trial evaluation
D: 40 years and above, both genders, who have clinical and radiographic osteoarthritis symptomatic for at least six months.

Answer: B