None listed
Conditions
Interventions
Group 1 Type of group
MK-0822 50 mg once a week and vitamin D3 5600 lU once a week
Group name:Group 2 Type of group
Placebo once a week and Vitamin D3 5600 lU once a week
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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 -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 -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 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
Exclusion criteria
Exclusion criteria: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:the first vertebral fracture morphometrically evaluated by patient determined from the X-rays of Month 6 and yearly Timepoints:Month 6 and yearly | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Lateral thoracic and lumbar radiographs will be obtained for each patient at baseline. Month 6, Month 12, and annually thereafter. Measure:The time for the first clinical vertebral fracture Timepoints:Month 6, Month 12, and annually ; Outcome name:Lateral thoracic and lumbar radiographs will be obtained for each patient at baseline. Month 6, Month 12, and annually thereafter. Measure:change with respect to basal height Timepoints:Month 6, Month 12, and annually | — |
Contacts
Public ContactSTELA Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed