EUCTR2006-000849-19-EE进行中（未招募）不适用
A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women with Low Bone Mineral Density
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
- Amgen Inc
- 入组人数
- 500
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
- •Inclusion Criteria from Section 4.1 of the Protocol
- •4.1.1 = 55 years of age at the start of screening.
- •4.1.2 Ambulatory postmenopausal women based on medical history.
- •Postmenopause will be defined as no vaginal bleeding or spotting for at least 12 months.
- •If there is uncertainty regarding menopausal status, confirmation of serum FSH (= 50 mIU/mL) and serum estradiol (= 20 pg/mL) must be obtained.
- •4.1.3 Have received alendronate treatment at a dose of 70 mg/week or equivalent (ie, 10 mg/day) for at least the past 6 months prior to screening.
- •4.1.4 Screening BMD (g/cm2) values, at the lumbar spine OR total hip, that occur within the following ranges, based on the particular scanner that is used:
- •GE Lunar Hologic
- •Lumbar spine 0.700 = BMD = 0.940 0.607= BMD = 0.827
- •Total hip 0.504 = BMD = 0.756 0.454 = BMD = 0.698
- •Both the initial and the repeat DXA scan of the lumbar spine OR the total hip must meet the above eligibility criteria. At least 2 lumbar vertebrae must be evaluable by DXA.
- •4.1.5 At least one hip must be evaluable by DXA (eg, no history of either bilateral hip replacement or pins in both hips).
- •4.1.6 Provide the appropriate written informed consent before any study-specific procedure.
- •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
- •Exclusion Criteria from Section 4.2 of the Protocol
- •4.2.1 Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- •4.2.2 Evidence of any of the following per subject report, chart review or central laboratory result:
- •1. Hyper- or hypothyroidism; however, subjects on stable thyroid hormone replacement therapy may be allowed per the following criteria:
- •If TSH level is normal, subject is eligible for the study.
- •If TSH level is below normal range, subject is not eligible for the study.
- •If TSH level is elevated (> 5.5 µIU/mL to 10.0 µIU/mL), serum T4 should be measured. If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal range, subject is not eligible for the study.
- •If TSH level is above 10.0 µIU/mL , subject is not eligible.
- •2. Current hyper- or hypoparathyroidism.
- •3. Elevated transaminases
- •Serum aspartate aminotransferase (AST; serum glutamate-oxaloacetic transaminase [SGOT]) = 2.0 x upper limit of normal (ULN).
- •Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) = 2.0 x ULN.
- •4. Significantly impaired renal function as determined by a derived creatinine clearance (using the Cockroft-Gault formula) of = 35 mL/min calculated by the central laboratory.
- •5. Current hypo- or hypercalcemia based on the central laboratory reference ranges. 6. Active gastric or duodenal ulcer; or any history of significant gastrointestinal bleed requiring hospitalization or transfusion.
- •7. Rheumatoid arthritis, Paget’s disease, Cushing’s disease, hyperprolactinemia, or cirrhosis of the liver.
- •8. Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen.
- •9. Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years.
- •10. Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings.
- •11. Malabsorption syndrome or any gastrointestinal disorder that is associated with malabsorption.
- •4.2.3 Previous participation in clinical trials with denosumab.
- •4.2.4 Received any solid organ or bone marrow transplant.
- •4.2.5 Any laboratory abnormality, which in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
- •4.2.6 Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (< 49.9 nmol/L)]. Vitamin D repletion will be permitted and subjects may be re-screened; see Section 7.
- •4.2.7 Contraindicated or poorly tolerant of ALN therapy; contraindications for ALN therapy include:
- •a) Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia.
- •b) Inability to stand or sit upright for at least 30 minutes.
- •c) Hypersensitivity to ALN or other constituents of ALN tablets.
- •4.2.8 Known sensitivity to mammalian cell derived drug products.
- •4.2.9 Known intolerance to calcium supplements.
- •4.2.10 Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate.
- •4.2.11 Administration of PTH or PTH derivatives (eg, teriparatide) within the last year.
- •4.2.12 Administration of any of the following treatments within 3 months of screening:
- •a) Any SERM (eg, raloxifene)
- •b) Tibolone
- •c) Anabolic steroids or testosterone
- •d) Glucocorticosteroids (
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