Postmenopausal Osteoporosis MedDRA version: 17.0 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: MK-0822
Product Code: MK-0822
Pharmaceutical Form: Tablet
Current Sponsor code: MK-0822
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3, 10, 25, & 5
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
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: 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 (e.g. heart failure, hypokalemia, family history of Long QT Syndrome), or (c) concomitant use of medications that prolong the QT/QTc interval (e.g. 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 procedures required in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective for the 12 Month 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. Primary Objective for the Extension Study to 24 Months: 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 24 months. ;Secondary Objective: Secondary Objectives for the 12 Month Base Study and 24 Month Extension: To assess the effect of L-001037536 3 mg-, 10 mg-, 25 mg-, and 50 mg- weekly on (1) total hip, femoral neck, trochanter, total body, and distal forearm BMD compared to placebo (2) biochemical indices of bone resorption (u-NTx, s-CTx, u-DPyr) compared to placebo. (3) biochemical indices of bone formation (s-BSAP, s-P1NP) compared to placebo. (4) indices of calcium and mineral homeostasis (s-calcium, s-phosphorus, s PTH, s-1,25-dihydroxyvitamin D, 24 h urine calcium) compared to placebo. (5) safety and tolerability compared to placebo. (6) To identify the optimal dosing regimen of L-001037536 based on each regimen’s overall effect on BMD, biochemical markers, and safety. ;Primary end point(s): Percent change from baseline in lumbar spine BMD | — |
Countries
Denmark, Sweden, United Kingdom
Contacts
Public ContactDeborah Gurner
Merck Sharp &Dohme Corp.
Outcome results
None listed