AN EXTENSION OF 12 MONTHS FOR: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF MK-0822 (KATEATE-K INHIBITOR) IN THE TREATMENT OF POST-MENOPAUSAL WOMEN WITH OSTEOPOROSIS
- Conditions
- -M80M80
- Registration Number
- PER-074-07
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient has met all the initial inclusion criteria and has not met any of the exclusion criteria of Protocol 004-01.
• The patient participated and completed the 24 months of treatment in Protocol 004-01 (to be determined in V13 / Month 24).
• The patient has, in general, good health, based on the medical history, physical examination and laboratory evaluation.
• • The patient has withdrawn from! Protocol 004-01 for any reason before completing the first extension (visit of month 24).
• The patient presented fracture in the hip, spine, or other fragility fracture during the baseline study and would prefer to receive another therapy for osteoporosis (bisphosphonates or PTH) for which she is eligible.
• The patient has used oral bisphosphonates in the last 6 months, bisphosphonates IV at any time, or has been treated with glucocorticoids (> 5 mg / day of prednisone or equivalent) for more than 2 weeks in the last 6 months.
• The patient has used estrogen ± progestin, raloxifene or another SERM, tamoxifen, tibolone, or an aromatase inhibitor or calcitonin.
• The patient is currently taking Vitamin A (excluding beta carotene)> 10,000 TU daily or Vitamin D> 5,000 lU daily.
• The patient was diagnosed with primary parathyroid disease during the baseline study and has elevated PTH or a serum calcium level higher than the upper limit of normal.
• The patient has hypocalcemia as defined as serum calcium level <8.5 mg / dL, when corrected for albumin, or shows evidence of secondary hyperparathyroidism.
• The patient experienced during the baseline study (a) a marked prolongation of the QT / QTc interval (eg, repeated demonstration of a QTc interval> 450), or (b) additional risk factors for Torsades de Pointes (eg, heart failure, hypokalemia) or (c) concomitant use of medications that prolong the QT / QTc interval (eg, quinidine, procainamide, disopyramide, tricyclic antidepressants, phenothiazines, amiodarone, or sotalol).
• The patient has significant clinical or laboratory abnormalities at the baseline of the extent that, in the opinion of the investigator, could complicate the interpretation of the study results or represent an additional risk to the patient (for example, patients who do not roam should be excluded for this reason).
• The patient has cancer or has had a diagnosis of any malignancy during the baseline study, with the exception of basal or squamous cell skin cancer or cervical cancer in situ adequately treated.
• The patient is, in the opinion of the investigator, mentally or legally incapacitated so that informed consent can not be obtained, or the patient does not know how to read or can not understand the written material.
• The patient has participated in the study of a research drug different from Protocol 004-01 within the last 30 days.
• The patient is currently a consumer of recreational or illicit drugs or has a recent history of drug or alcohol abuse or dependence.
• The patient shows that she does not comply with the procedures required in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The resolution of the effect will be evaluated by the percentage change with respect to the baseline in Month 36 for patients who received 50 mg of MK-0822 for 3 years versus those who received 50 mg of MK-0822 in the central period of 2 years and they switched to the placebo for the 3rd year of the extension.<br>Measure:Percentage change with respect to the baseline BMD of the lumbar spine.<br>Timepoints:36 months<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The long-term effects will be evaluated according to the percentage change with respect to the baseline over time. The percentage change with respect to Month 24 in Months 30 and 36 will be summarized.<br>Measure:The percentage change with respect to the baseline in the BMD measurements in the total hip, femoral neck, trochanter, whole body and distal forearm.<br>Timepoints:Month 24 in Months 30 and 36<br>;<br>Outcome name:Analyzed as the fraction transformed logarithmically with respect to basal.<br>Measure:Change from baseline in the biochemical markers of bone resorption (s-CTX, u-NTx, u-DPyr, s-TRAP 5b and s-ICTP) and bone formation (s-BSAP, s-PlNP),<br>Timepoints:24 months<br>