A PHASE III CLINICAL TRIAL, RANDOMIZED, CONTROLLED WITH PLACEBO, TO EVALUATE THE SAFETY AND EFFICACY OF ODANACATIB (MK-0822) TO REDUCE THE RISK OF FRACTURES IN POST-MENOPAUS WOMEN WITH OSTEOPOROSIS TREATED WITH VITAMIN D AND CALCIUM
- Conditions
- -M80-M85-M99M80M85M99
- Registration Number
- PER-119-07
- 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
- 607
• The patient is a woman who is> 65 years old on the day of signing the informed consent.
• The patient meets one of the following characteristics: a) The patient is a candidate for osteoporosis therapy (bisphosphonate, strontium or PTH), has a T score of BMD <-1.5 at the total hip or femoral neck site, BMD T-score> -4.0 at both sites and has a previous vertebral fracture (defined as loss of average or later height of> 20%) b) The patient is a candidate for osteoporosis therapy (bisphosphonate, strontium or PTH) , has a T score of BMD <-2.5 at the total hip or femoral neck site, BMD T score> -4.0 at both sites and does not have a previous vertebral fracture (defined as loss of average or later middle height of> 20) %) c) The patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium or PTH), has a T score of BMD <- 1.5 at the total hip site or femoral bone, and has at least one previous vertebral fracture (defined as pe loss of previous, middle or later stature of> 20%) d) The patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium or PTH), and has a T score of BMD <2.5 in the site of the total hip or femoral bone.
• The patient has at least one hip that can be evaluated by DXA (eg, does not contain hardware for orthopedic procedures).
• The patient has been postmenopausal for at least 5 years, defined as having no menses for at least 5 years, or at least 5 years of post-bilateral oophorectomy status.
• The patient understands the study procedures, available alternative treatments and the risks involved with this study, and voluntarily agrees to participate by submitting an informed written consent.
• The patient is not hospitalized.
• The patient can read, understand and complete questionnaires and diaries
• The patient has chosen treatment with oral bisphosphonates or other agents that have been shown to reduce the risk of hip fracture.
• The patient has suffered a previous fracture in the hip.
• The patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: fractures of the finger, toe, and skull will not be considered with respect to this exclusion criteria).
• The patient has suffered more than one previous vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a suitable candidate for osteoporosis therapy (ie bisphosphonates, strontium or PTH).
• The patient presents or has presented evidence of a metabolic bone disorder in addition to osteoporosis.
• The patient has a history of kidney stones and serum calcium, 25-hydroxyvitamin D and serum PTH that is not within normal limits.
• The patient has active parathyroid disease. (Note, the serum PTH level should be evaluated in the selection for patients with a documented history of parathyroid disease Patients with a history of primary hyperparathyroidism and with curative parathyroidectomy> 2 years before selection are not excluded).
• The patient has a history of thyroid disease that is not adequately controlled by the drug. (Note: in patients with a documented history of thyroid disease, TSH and the free thyroxine index should be evaluated in the selection).
• The patient has serum creatinine> 1.6 mg / dL and is considered to have severe renal impairment defined as calculated creatinine clearance <29 ml / min (National Kidney Foundation K / DOQI Guidelines)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:analyzed as survival information counted by interval. All available x-ray information will be included in the analyzes, and the time windows will be determined in the SAP to define the schedule.<br>Measure:the first vertebral fracture morphometrically evaluated by patient determined from the X-rays of Month 6 and yearly<br>Timepoints:Month 6 and yearly<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Lateral thoracic and lumbar radiographs will be obtained for each patient at baseline. Month 6, Month 12, and annually thereafter.<br>Measure:The time for the first clinical vertebral fracture<br>Timepoints:Month 6, Month 12, and annually<br>;<br>Outcome name:Lateral thoracic and lumbar radiographs will be obtained for each patient at baseline. Month 6, Month 12, and annually thereafter.<br>Measure:change with respect to basal height<br>Timepoints:Month 6, Month 12, and annually<br>