EUCTR2010-020342-98-LT进行中（未招募）不适用
A Double-Blind, Randomized, Repeat Dose, Parallel Group Study of Recombinant Human Parathyroid Hormone (rhPTH(1-31)NH2) tablets, or Placebo tablets, Compared to Open Label Forsteo in Postmenopausal Women with Osteoporosis
nigene Laboratories, Inc.0 个研究点目标入组 93 人开始时间: 2011年1月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Informed Consent: Provide written informed consent before initiation of any study related procedures.
- •Ambulatory postmenopausal women in good health. Menopausal status: Patient should be at least 5 years postmenopausal which can be =5 years of spontaneous amenorrhea or =5 years postsurgical bilateral oophorectomy. Use follicle stimulation hormone (FSH) levels >40 mIU/mL to confirm surgical postmenopausal status where bilateral oophorectomy status is uncertain.
- •Age = 45 years, =80 years.
- •BMD Values: Diagnosis of osteoporosis on the basis of an axial lumbar spine, femoral neck or total hip BMD which is below the mean for premenopausal women by a magnitude of at least 2.5 SD or 2.0 SD, if there is a documented (x-ray) history of a vertebral fragility fracture.
- •Suitable Vertebrae: Two or more vertebrae in the range of L1 to L4 that are suitable for BMD measurement by DXA.
- •No clinically significant abnormal findings in the medical history or physical examination.
- •- Negative screen for Hepatitis B and C, HIV and drugs of abuse at screening.
- •Laboratory Values:
- •- Total serum Ca, albumin-adjusted Ca, P, and Mg++ within normal range.
- •- No clinically significant abnormal laboratory values at the screening assessment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •BMI =33 kg/m2
- •Illnesses:
- •- Liver function: Known hepatic or biliary abnormalities including Gilbert's syndrome.
- •- Clinically significant abnormal liver function tests (ALT, AST, GGT, alkaline phosphatase, total bilirubin).
- •- Abnormal kidney function tests: Creatinine clearance =30 ml/min; urinary calcium/creatinine ratio greater than 1.1 mmol/mmol on second morning voided specimen; or serum creatinine concentration exceeding 2 mg per deciliter (177 µmol per liter
- •- Medical illness: Presence of acute or chronic illness or history of chronic illness which, in the judgment of the Investigator, makes participation in the study medically inappropriate.
- •- History of pancreatitis, osteosarcoma, gout, or kidney stones (calcium oxalate or calcium phosphate).
- •- Uncontrolled hypertension, significant gastrointestinal abnormalities, uncontrolled diabetes mellitus, any psychotic mental illness, uncorrected endocrine dysfunction, or significantly impaired respiratory or renal function.
- •- Medical conditions which might alter bone metabolism, including: hyperparathyroidism, hypoparathyroidism, untreated hyperthyroidism, untreated hypothyroidism, Paget's disease, myeloma, malabsorption, Cushing's syndrome, hypocalcemia, hypercalcemia, hypophosphatemia, hyperphosphatemia, hypomagnesemia, hypermagnesemia, osteopetrosis, osteomalacia, rheumatoid arthritis and recent (within one year) history of non-traumatic fracture or prolonged bed rest.
- •- History of musculoskeletal disease. However, patients with conditions such as fibromyalgia, osteoarthritis, and degenerative disc disease may be enrolled at the discretion of the Investigator and Medical Monitor.
- •- History of cancer within 5 years of enrollment other than basal cell carcinoma and carcinoma in situ.
- •History of clinically significant Cardiovascular Disease and/or Postural Hypotension:
- •- QT/QTc prolongation: A marked baseline prolongation of QT/QTc interval (e.g., QTc interval > 450 msec on the screening ECG).
- •- Torsades des Pointes: A history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- •Electrocardiogram: Any clinically relevant abnormality identified on the 12-lead surface electrocardiogram (ECG).
- •History of Surgery within 60 days of enrollment.
- •Evidence of Alcohol or Substance Abuse that the Investigator believes would interfere with understanding or completing the study.
- •Laboratory Findings:
- •- Albumin-adjusted serum calcium greater or less than 10% of the normal reference range of the analytical laboratory.
- •- Urine calcium greater than the normal reference range of the laboratory.
- •- PTH(1-84) greater than the normal reference range of the analytical laboratory.
- •- Abnormal Alkaline Phosphatase.
- •- Vitamin D: Vitamin D insufficiency defined as a 25 hydroxyvitamin D level <15 ng/mL.
- •- Any condition or disease that may interfere with the ability to have a DXA scan or to evaluate a DXA scan, for example, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or more than 1 lumbar vertebral fracture in L1 through L4.
- •- Bilateral hip replacements.
- •Contraindicated Medications: Contraindicated medications are defined in Table 4 2.
- •Osteosarcoma Risk: Patients at increased risk of osteosarcoma such as those with Paget’s disease of bone or any prior external beam or implant radiation therapy involving the skeleton.
- •Contraindications: Con
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