evt_NCT00691678_v6_v7_30600572a472

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  "citation_text": "TrialDiff Evidence Record evt_NCT00691678_v6_v7_30600572a472. ClinicalTrials.gov NCT00691678, versions 6-7. Evidence version 1.",
  "claims_not_supported": [
    "That the amendment was scientifically unjustified.",
    "That the change constitutes misconduct or wrongdoing.",
    "That sponsor intent can be inferred from this registry change.",
    "That the change caused or altered the trial's results.",
    "That the change was or was not disclosed in a manuscript.",
    "That TrialDiff determines regulatory compliance or non-compliance.",
    "That co-occurrence with results posting proves the outcome edit was harmless, administrative, or substantively benign.",
    "That event-class membership is a validated global review-priority ranking."
  ],
  "claims_supported": [
    "TrialDiff compared ClinicalTrials.gov record version 6 to version 7 for NCT00691678.",
    "The JSON Patch for this comparison has hash dc39f1fc2b03cafe022ce79ecd469bf2bace3dd5dc51eabea3b53436608b50c6.",
    "The active deterministic rule set hash was fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621.",
    "The deterministic triage label was high; before timing adjustment it was high.",
    "The triage label is uncalibrated metadata, not a validated review-priority finding.",
    "The patch satisfied these deterministic event-class predicates: outcome_edit_cooccurs_with_results_posting.",
    "A registry field under an arm or intervention module changed between ClinicalTrials.gov versions 6 and 7.",
    "The timing context for the from-version record was post_recruitment.",
    "The deterministic rules that fired were: arms_or_interventions_change, eligibility_criteria_change.",
    "The changed JSON Pointer paths were: /protocolSection/statusModule/statusVerifiedDate, /protocolSection/statusModule/lastUpdateSubmitDate, /protocolSection/statusModule/lastUpdatePostDateStruct/date, /protocolSection/statusModule/resultsFirstSubmitDate, /protocolSection/statusModule/resultsFirstSubmitQcDate, /protocolSection/statusModule/resultsFirstPostDateStruct, /protocolSection/armsInterventionsModule/interventions/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/measure, /protocolSection/outcomesModule/primaryOutcomes/0/description, /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame, /protocolSection/eligibilityModule/eligibilityCriteria, /annotationSection, /hasResults, /resultsSection.",
    "An outcome path changed between versions 6 and 7 in a patch that also carried a hasResults or resultsSection co-occurrence signal."
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    "rule_set_hash": "fc87f4f0a74bc789dbe4ba85893c2c96f55db62c22970be4e991288104291621",
    "severity": "high",
    "severity_pre_timing": "high",
    "timing_context": "post_recruitment",
    "triage_label": "high",
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        "severity": "low",
        "signal": "results_reconciliation_outcome_suppression"
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  "event_id": "evt_NCT00691678_v6_v7_30600572a472",
  "evidence_version": 1,
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      "value": "400mg chondroitin three times a day (TID) for twenty-four weeks"
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      "value": "Change in WOMAC Score"
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      "value": "This is to demonstrate improvement in knee and/or joint pain and/or stiffness.\nThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.\nIt is a self-administered questionnaire consisting of 24 items divided into 3 subscales.\nThe scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.\nThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).\nThe sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96.\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations."
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      "value": "<p>Inclusion Criteria:</p><ul><li>Age &gt;21 years.</li><li>Postmenopausal status defined as cessation of menses for &gt;1 year or follicle-stimulating hormone (FSH) &gt;20 milli-international units per milliliter or bilateral oophorectomy.</li><li>History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease.</li><li>Currently taking a third-generation aromatase inhibitor for at least 3 months.</li><li>Clinical symptoms of knee and&#x2F;or hand joint pain and&#x2F;or stiffness for at least 3 months prior to study entry.</li><li>Ongoing musculoskeletal pain&#x2F;stiffness in hand and&#x2F;or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months.</li><li>Patients must agree to refrain from use of glucosamine and chondroitin from sources outside of this study.</li><li>If taking bisphosphonates, on a stable dose for at least 3 months and tolerating the dose.\nPatients must agree to refrain from initiating bisphosphonate use during the course of the study, therefore it is recommended that routine bone density testing be performed prior to enrollment or after completing trial.</li><li>Eastern Cooperative Oncology Group (ECOG) performance status 0-2.</li><li>Hemoglobin A1c &lt;8 within the last year.</li><li>Signed informed consent.</li></ul><p>Exclusion Criteria:</p><ul><li>Use of glucosamine or chondroitin within the past three (3) months.</li><li>Concurrent medical&#x2F;arthritic disease that could confound or interfere with evaluation of pain or efficacy.</li><li>History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).</li><li>History of bone fracture or surgery of the afflicted knees and&#x2F;or hands within 6 months prior to study entry.</li><li>Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of &gt; 8%.</li><li>History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.</li><li>Allergy to, or history of significant clinical or laboratory adverse experience associated with acetaminophen, glucosamine or chondroitin sulfate.</li><li>Allergy to shellfish.</li><li>Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.</li><li>Inability to understand the study procedures and&#x2F;or give written informed consent.</li><li>Alcohol use in excess of 3 mixed drinks&#x2F;day.</li><li>Corticosteroid treatment was used or administered.</li><li>Aspirin (up to 325 mg&#x2F;day) for cardiovascular reasons may be continued.</li><li>Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.</li><li>Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and acetaminophen) within 2 weeks of baseline visit or during the study.</li><li>Implementation of any other medical therapy for arthritis within one month prior to entry.</li><li>Other medications, unrelated to the patient&#x27;s joint pain&#x2F;stiffness must have been used at a stable dosage for at least 1 month.\nIn addition, it should be anticipated that the dose of the concomitant medication will be stable during the entire treatment period.</li><li>Participation in another clinical study with an investigational agent within the last 4 weeks.</li><li>Exposure to glucosamine within 3 months or chondroitin sulfate within 3 months of Baseline Visit.</li><li>Initiation of physical therapy or muscle conditioning program within 2 months prior to study entry.</li><li><p>Concurrent use of the following medications and dietary supplements.</p><ul><li>Chronic therapy with tetracycline or tetracycline derivatives.</li><li>Other new complementary or alternative regimens for the treatment of osteoarthritis, including, but not limited to, acupuncture, topical creams, oral agents, and magnets.</li></ul></li></ul>"
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              "term": "Abdominal distension"
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              "term": "Stomach Pain"
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            {
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              "organSystem": "Metabolism and nutrition disorders",
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              "term": "Weight gain"
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                  "numEvents": 2
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              "term": "Fatigue"
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              "assessmentType": "NON_SYSTEMATIC_ASSESSMENT",
              "organSystem": "Immune system disorders",
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              "term": "Allergic reaction"
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                  "numEvents": 1
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              ],
              "term": "Bleeding at the biopsy site"
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          "timeFrame": "Up to 24 weeks"
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              "description": "<p>Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.</p><p>Chondroitin: 400mg chondroitin TID for twenty-four weeks</p><p>Glucosamine: 500mg glucosamine TID for twenty-four weeks</p>",
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                  "title": "18 - 58 years"
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                      "title": "Hispanic or Latino"
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                      "title": "Not Hispanic or Latino"
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                      "title": "Unknown or Not Reported"
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                      "title": "White"
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                      "title": "More than one race"
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          "pointOfContact": {
            "email": "dlh23@cumc.columbia.edu",
            "organization": "Columbia University",
            "phone": "212-305-1945",
            "title": "Dawn L. Hershman, MD"
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                  "groupDescription": "This statistical analysis measures whether there is a statistically significant change, at the 5% significance level, between the mean WOMAC score among study participants at baseline and at week 24.",
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              ],
              "description": "This is to demonstrate improvement in knee and&#x2F;or joint pain and&#x2F;or stiffness.\nThe Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis.\nIt is a self-administered questionnaire consisting of 24 items divided into 3 subscales.\nThe scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.\nThe test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).\nThe sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96.\nHigher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.",
              "dispersionType": "Standard Deviation",
              "groups": [
                {
                  "description": "<p>Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.</p><p>Chondroitin: 400mg chondroitin TID for twenty-four weeks</p><p>Glucosamine: 500mg glucosamine TID for twenty-four weeks</p>",
                  "id": "OG000",
                  "title": "Chondroitin and Glucosamine"
                }
              ],
              "paramType": "MEAN",
              "populationDescription": "At completion of the study, there were 39 evaluable subjects (this excludes participants who were not available for follow-up) out of the 53 enrolled.",
              "reportingStatus": "POSTED",
              "timeFrame": "Baseline and 24 weeks",
              "title": "Change in WOMAC Score",
              "type": "PRIMARY",
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            }
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              "description": "<p>Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.</p><p>Chondroitin: 400mg chondroitin three times a day (TID) for twenty-four weeks</p><p>Glucosamine: 500mg glucosamine TID for twenty-four weeks</p>",
              "id": "FG000",
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                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "37"
                    }
                  ],
                  "type": "COMPLETED"
                },
                {
                  "achievements": [
                    {
                      "groupId": "FG000",
                      "numSubjects": "16"
                    }
                  ],
                  "type": "NOT COMPLETED"
                }
              ],
              "title": "Overall Study"
            }
          ],
          "preAssignmentDetails": "Of the 16 participants that dropped out of the study, 5 did so because of the number of pills, 8 due to adverse events and uncontrolled pain, and 3 dropped out due to other life events.\n40 participants completed the 12 week assessment; 27 participants completed the 24 week assessment.",
          "recruitmentDetails": "53 women were enrolled in this study at baseline, 16 dropped out before the week 24 assessment. in total, there were 39 evaluable participants."
        }
      }
    }
  ],
  "provenance": {
    "from_snapshot_hash": "b3adb85ffe53c9b8e558c5140b36cb772c4a83a8d3fb58592e475e52a6641a32",
    "materiality_event_hash": "fe88f916a4b2856e089b0458673ec503d759666a8b28a45b9d616c7538c0d34b",
    "patch_hash": "dc39f1fc2b03cafe022ce79ecd469bf2bace3dd5dc51eabea3b53436608b50c6",
    "patch_raw_hash": "89b951407f1aa8e0a2f07c5aac1691e5ea53bce2b44b4e20788380e2144cb8e7",
    "patch_source": "ctgov_internal_history",
    "patch_source_url": "https://clinicaltrials.gov/api/int/studies/NCT00691678/history/6?patchToVersion=7",
    "to_snapshot_hash": null
  },
  "review_question": "What source document explains this registry amendment, and does it change interpretation of the trial record?",
  "schema": "trialdiff.evidence_record",
  "trial": {
    "clinicaltrials_gov_url": "https://clinicaltrials.gov/study/NCT00691678",
    "nct_id": "NCT00691678"
  },
  "versions": {
    "from_version": 6,
    "submitted_date": "2022-10-14",
    "to_version": 7
  }
}