Postmenopausal Osteoporosis MedDRA version: 14.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: L-001037536
Product Code: MK-0822
Pharmaceutical Form: Tablet
Current Sponsor code: L-001037536
Other descriptive name: MK
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Postmenopausal female (> 5 years) between 45-85 years old. T-score at the hip (femoral neck, trochanter or total) or lumbar spine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Base study: The patient has a BMD T-score at the spine or hip (femoral neck, trochanter, or total) 2 months use at any time), or any I.V. bisphosphonates, c) cyclosporin for more than 2 weeks within the prior 6 months, d) fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks at any time, e) strontium (at any time) f) PTH within 12 months, g) current use of phenytoin, chemotherapy, or heparin, or h) use of growth hormone at any time. The patient has used estrogen ± progestin, raloxifene or other SERM, tamoxifen, tibolone, or an aromatase inhibitor within the prior 6 months or calcitonin within the prior 30 days. (Note: Vaginal estrogen creams used topically = twice weekly will be permitted). The patient is currently taking Vitamin A (excluding beta carotene) > 10,000 IU daily or Vitamin D > 5,000 IU daily and not willing to discontinue this dose during the study. The patient has primary parathyroid disease with an elevated PTH or in conjunction with serum calcium greater than the upper limit of normal. (Note: patients with a history of primary hyperparathyroidism and with curative parathyroidectomy = 2 years are not excluded). The patient has a TSH 450), or b) additional risk factors for Torsades de Pointes (eg. heart failure, hypokalemia, family history of Long QT Syndrome), or c) concomitant use of medications that prolong the QT/QTc interval (eg. quinidine, procainamide, disopyramide, tricyclic antidepressants, phenothiazines, amiodarone or sotalol) will be excluded. The patient has significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient. The patient has a significant, unexplained laboratory abnormality. The patient has cancer or had a diagnosis of any malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer The patient is, in the opinion of the investigator, mentally or legally incapacitated such that informed consent cannot be obtained or the patient cannot read or comprehend the written material. The patient has participated in an investigational drug study within the past 30 days. The patient is currently a user of any illicit drug and/or has a history of alcohol abuse. The patient demonstrates noncompliance in following the procedur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For Base Study: To assess the effect of L-001037536 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months. For 24 Months Extension: To assess the time course of the resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with MK 822 once weekly in postmenopausal women with osteoporosis. Extension to 36 months: To assess the resolution of effect at 36 months on lumbar spine BMD following 24 months of treatment with MK-0822 once weekly in post-menopausal women with osteoporosis. Extension to 5 years:To estimate BMD differences at the lumbar spine during years 3-5 in post-menopausal osteoporotic women 5 year open-label extension: 1) To estimate the change from baseline on lumbar spine BMD at years 8 & 10 with MK-0822 in postmenopausal osteoporotic women 2) to assess the safety of treatment with MK-0822 50 mg once weekly for up to 10 years. ; Secondary Objective: For base and 24 Month Extension: To assess the effect of 3, 10, 25, and 50 mg- on (1) total hip, femoral neck, trochanter, total body, and distal forearm BMD (2) biochemical indices of bone resorption (u-NTx, s-CTx, u-DPyr) and bone formation (s-BSAP, s-P1NP) (3) indices of calcium and mineral homeostasis (s-calcium, s-phosphorus, s PTH, s-1,25-dihydroxyvitamin D, 24 h urine calcium) (4) safety and tolerability (5) Iidentify the optimal dose. Up to 5 years: 1) to assess long-term safety 2) in patients previously taking 10, 25, or 50 mg for 2 years, to assess the effect at month 36 of treatment with 50 mg and without treatment on all markers stated above for the base study. 5 year open label extension: to estimate the change with 50 mg from baseline and from month 60 1) in BMD at the lumbar spine, total hip, femoral neck, hip trochanter, and one-third | — |
Countries
Denmark, Sweden, United Kingdom
Outcome results
None listed