EUCTR2009-014729-18-FR进行中（未招募）1 期
A Phase IIb, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated with an Oral Bisphosphonate
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 670
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
入选标准
- •1.-The patient is a woman 45 to 85 years of age, inclusive.
- •2. The patient has been postmenopausal for >=5 years, defined as no menses for at least 5 years, OR at least 5 years status post bilateral oophorectomy.
- •3. The patient is currently taking alendronate for treatment of osteoporosis (either 70 mg once weekly with or without vitamin D3, or 10 mg daily), and has taken alendronate during the 12 consecutive months prior to Visit 1 (and no other bisphosphonate). In addition, the patient has taken bisphosphonates for treatment of osteoporosis for at least 3 years within the 4 years prior to screening (i.e. while in the 1st year prior to screening the bisphosphonate must be alendronate, for the 2nd, 3rd, and 4th years prior to screening the patient could have taken any one or combination of oral bisphosphonates for at least 2 of those 3 years).
- •4. Patients must have been approximately 80% compliant with either once-weekly or
- •daily alendronate during the 12 consecutive months prior to Visit 1, and therefore, to
- •the best of their recollection, may not have missed a total of more than 12 weekly
- •doses during the past year, or a total of more than 73 daily doses during that time.
- •5. The patient has, at screening either: (1) an areal BMD T-score <= -2.5 at one or more of the lumbar spine, femoral neck, trochanter, or total hip, and a BMD T-score at all of these sites that is > = -4.0, with or without a history of a prior vertebral or nonvertebral fragility fracture; OR (2) an areal BMD T-score <= -1.5 at one or more of
- •these 4 sites, and a BMD T-score at all of these sites that is >= -4.0, and at least one
- •prior vertebral or non-vertebral fragility fracture documented by medical record, or
- •detected on the screening spine radiographs by the local radiologist. Only the Tscores provided by the central imaging vendor can be used to determine eligibility.
- •Hip BMD measurements should be performed on the left hip only, unless the left hip
- •is not evaluable.
- •6. Patient has no increased risk of bone cancer due to any reason, such as a history of skeletal malignancy at any time, or a history of therapeutic irradiation.
- •7. Patient's weight or body mass index (BMI) at screening does not preclude the
- •acquisition of DXA and CT images of good quality.
- •8. The patient has a 25-hydroxyvitamin D level as measured by the central laboratory of >=15 ng/mL. Note: If the 25-hydroxyvitamin D level is >=9 and <15 ng/mL, she may enter if her alkaline phosphatase and PTH levels, as measured by the central laboratory, are normal. Note: Patients with a serum 25-hydroxyvitamin D level (as measured by the central laboratory) that does not qualify for this study may have it retested once during the screening period.
- •10. During the run-in period, patient took the placebo for MK-5442, and the calcium
- •supplement (if dispensed during the run-in period), on at least 11 of the 14 days (i.e., approximately 80% of the time) following the dosing instructions described in
- •Section 3.2.5. Patients who fail this entrance criterion may not have the run-in period
- •repeated unless specifically approved by the SPONSOR.
- •11. During the run-in period,
排除标准
- •1. The patient has received the following agents with action on bone (all time periods
- •are relative to Visit 1):
- •(a) IV bisphosphonates (e.g., zoledronic acid) at any time in the past
- •(b) fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks at any
- •time in the past,
- •(c) strontium at any time in the past,
- •(d) growth hormone at any time in the past,
- •(e) any cathepsin K inhibitor, such as MK-0822/odanacatib, at any time in the past,
- •(f) use of denosumab or any other RANK-L inhibitor at any time in the past,
- •(g) oral bisphosphonates other than alendronate within the past 12 months
- •(h) PTH (1-34, or 1-84) at any time within the prior 24 months,
- •(i) cyclosporin for more than 2 weeks within the prior 6 months,
- •(j) heparin within the prior 2 weeks,
- •(k) anabolic steroids or glucocorticoids (>=5 mg/day prednisone or equivalent) for
- •more than 2 weeks in the prior 6 months,
- •(l) prescription soy isoflavones (e.g., Genistein, Diadzein, IsofemTM) used to treat
- •osteoporosis within the prior 6 months
- •2. The patient has used estrogen ± progestin, raloxifene, tamoxifen, tibolone or another selective estrogen receptor modulator (SERM) within the 6 months prior to Visit 1, or calcitonin within the prior 30 days. (Note: vaginal estrogen creams used topically once or twice weekly are permitted.) 2.3. The patient has used either pioglitazone hydrochloride, or rosiglitazone maleate, within the 6 months prior to Visit 1.
- •4. The patient is currently taking vitamin A (excluding beta carotene) >10,000 IU daily, or vitamin D >5,000 IU daily, and is not willing to reduce her vitamin A dose to
- •<=10,000 IU daily, and her vitamin D dose to an equivalent of <=2000 IU daily (including the weekly vitamin D supplementation being provided for this study) during the study.
- •5. Patient anticipates the use of any of the following potent inhibitors or potent inducers of CYP3A4 within 2 weeks prior to randomization or during the study.
- •6. The patient has primary parathyroid disease, or secondary hyperparathyroidism with an elevated PTH. (Note: patients with a history of primary hyperparathyroidism and with curative partial parathyroidectomy ≥2 years prior to the screening visit are not excluded).
- •7. The patient has had prior total thyroidectomy (patient with a hemithyroidectomy may be included).
- •8. Patient has any history of Paget's disease of bone.
- •9. Patient is known to be HIV positive or is known to have an AIDS-related illness. 10. Patient has a history of malignancy <= 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
- •11. The patient has evidence of a metabolic bone disorder other than osteopenia or
- •osteoporosis (e.g., rickets, osteomalacia).
- •12. The patient has a history of recent major upper gastrointestinal (GI) (esophagus,
- •stomach, duodenum) mucosal erosive disease as defined by (a) significant upper GI
- •bleeding within the previous year resulting in hospitalization and/or transfusi
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