{
    "info": {
        "nct_id": "NCT00838201",
        "official_title": "An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer",
        "inclusion_criteria": "* Subjects must be currently participating in the 20040138 Amgen study\n* Subjects must sign the informed consent before any study specific procedures are performed.\n\nExclusion Criteria\n\n* Subjects with any prior diagnosis of bone metastasis\n* Known hypocalcemia\n* Developed sensitivity to mammalian cell derived drug products during the 20040138 study\n* Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study\n* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Subjects must be currently participating in the 20040138 Amgen study",
            "criterions": [
                {
                    "exact_snippets": "Subjects must be currently participating in the 20040138 Amgen study",
                    "criterion": "participation in the 20040138 Amgen study",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "currently participating"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must sign the informed consent before any study specific procedures are performed.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must sign the informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with any prior diagnosis of bone metastasis",
            "criterions": [
                {
                    "exact_snippets": "any prior diagnosis of bone metastasis",
                    "criterion": "bone metastasis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypocalcemia",
            "criterions": [
                {
                    "exact_snippets": "Known hypocalcemia",
                    "criterion": "hypocalcemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Developed sensitivity to mammalian cell derived drug products during the 20040138 study",
            "criterions": [
                {
                    "exact_snippets": "Developed sensitivity to mammalian cell derived drug products",
                    "criterion": "sensitivity to mammalian cell derived drug products",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study",
            "criterions": [
                {
                    "exact_snippets": "Currently receiving any investigational product other than denosumab",
                    "criterion": "investigational product",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "having received any investigational product during the 20040138 study",
                    "criterion": "investigational product",
                    "requirements": [
                        {
                            "requirement_type": "past use during 20040138 study",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures",
            "criterions": [
                {
                    "exact_snippets": "Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent",
                    "criterion": "disorder affecting ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Any disorder that, in the opinion of the investigator, may ... comply with study procedures",
                    "criterion": "disorder affecting ability to comply with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Exclusion Criteria",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}