/A
- Conditions
- Treatment of Osteoporosis in Postmenopausal Women
- Registration Number
- EUCTR2009-014729-18-GB
- Lead Sponsor
- Merc & Co. Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 670
1. The patient is a woman 45 to 85 years of age, inclusive and 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.
9. The patient has a serum PTH value at screening that does not exceed the upper limit of normal (as measured by the central laboratory). Note: Patients with a serum PTH value above the upper limit of normal as measured by the central laboratory may have their serum PTH retested once during the screening period if the investigator believes the elevation is due to a low 25-hydroxyvitamin D. In that case, the patient should be supplemented with vitamin D before the PTH retest.
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) . Patients who fail this entrance criterion may not have the run-in period repeated unless specifically approved by the S
1. Has received the following agents with action on bone : IV bisphosphonates (e.g., zoledronic acid) ; strontium; growth hormone; any cathepsin K inhibitor, such as MK-0822/odanacatib; use of denosumab or any other RANK-L inhibitor; fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks at any time in the past; oral bisphosphonates other than alendronate within the past 12 months; PTH (1-34, or 1-84) at any time within the prior 24 months; cyclosporin, anabolic steroids or glucocorticoids ( 5 mg/day prednisone or equivalent) for more than 2 weeks within the prior 6 months; heparin within the prior 2 weeks; prescription soy isoflavones (e.g., Genistein, Diadzein, IsofemTM) used to treat osteoporosis within the prior 6 months
2. 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.)
3.Has used either pioglitazone hydrochloride, or rosiglitazone maleate,
within the 6 months prior to Visit 1.
4. 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. 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:
grapefruit juice; systemically administered azole antifungals such as ketoconazole, fluconazole; itraconazole, miconazole, posaconozole, ravuconazole, and voriconazole; nefazodone; the macrolide antibiotics clarithromycin, dirithromycin, erythromycin, and troleandomycin; (Azithromycin use is permitted (the use of any other macrolide antibiotic requires approval by the SPONSOR); protease inhibitors; rifampin; rifabutin; orally administered dexamethasone; phenytoin; any barbiturate, e.g., phenobarbital or primidone; St. John’s Wort. Patients who discontinue these medications/grapefruit juice at least two weeks prior to randomization and do not plan their use during the study are eligible.
6. 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. Has had prior total thyroidectomy (patient with a hemithyroidectomy may be included).
8. Has any history of Paget’s disease of bone or evidence of a metabolic bone disorder other than osteopenia or osteoporosis.
9. Is known to be HIV positive or is known to have an AIDS-related illness.
10. Has a history of malignancy 5 years prior except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
11. Has a history of recent major upper GI mucosal erosive disease as defined by (a) significant upper GI bleeding within the previous year resulting in hospitalization and/or transfusion; (b) recurrent ulcer disease documented by radiographic or endoscopic means (2 episodes in the last 2 years, or any documented ulcer in the preceding 3 months); (c) uncontrolled dyspepsia being treated on a daily basis; (d) esophageal or gastric variceal disease; or (e) oesophageal stricture
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method