None listed
Conditions
Interventions
Group 1 Type of group
Alendronate 70 mg once a week + placebo for
raloxifene daily for 12 months
Group name:Group 2 Type of group
Placebo for Alendronate once a week + Raloxifene
60 mg daily for 12 months
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is an ambulatory woman, who lives in the community, aged 40 or older, (25 years old or older, if it is a menopausal woman by surgery), postmenopausal for at least 6 months, with osteoporosis [density Bone mineral> 2.0 standard deviation below normal average bone mass in young people, either for the PA lumbar spine (L1 to L4) or for the total hip, according to the normative database provided by Hologic, Inc.] . • The patient has a good state of health, based on the clinical history, the physical examination, and the evaluation of laboratory selection, all of which allows her to complete the trial without predicting serious comorbid events. • The patient understands the study procedures, has been informed of alternative treatments for osteoporosis, and voluntarily agrees to participate in the study. • The patient has a proper anatomy of the spine for dual-energy x-ray absorptiometry of the lumbar spine. In the lumbar spine there should not be a significant scoliosis, or bone deformity or sequelae of orthopedic procedures resulting in an inappropriate anatomy. At least three of the vertebrae L1 to L4 must be evaluable.
Exclusion criteria
Exclusion criteria: • The patient is mentally or legally incapacitated, or is otherwise unable to give informed consent. • The patient is a pregnant or lactating woman, or a potentially fertile woman. • The patient participated in another therapeutic trial with a compound under investigation within 30 days prior to randomization. • The patient plans to move during the following year, which would impractical follow-up. • The patient has a history of hypersensitivity to any of the components of the alendronate or raloxifene tablets. • The patient has a history of any disease or has significant abnormalities in the clinical or laboratory evaluation of a pre-study, which, in the opinion of the researcher, could constitute an unacceptable risk for the patient when participating in this study, or complicate the interpretation of the data. • The patient has bilateral hip prostheses. • The patient has an abnormality in the esophagus that delays esophageal emptying, such as a constriction or achalasia. • The patient is unable to stand or sit upright for at least 30 minutes once a week. • The patient currently uses any illicit drug, or has a history of drug or alcohol abuse within the last five years. • The patient has active or past history of venous thromboembolic events, which include deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis. • The patient has a history of hepatic dysfunction defined as an elevation of aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase more than 2 times the normal upper limit, or with a serum bilirubin level above the upper normal limit . • The patient has any of the following conditions: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension, but not controlled; new onset of angina pectoris or myocardial infarction within six months prior to entering the study; evidence of impaired renal function, defined as creatinine clearance <35 ml / min or serum creatinine greater than 1.6 mg / dl; organ transplant; or any other major terminal organ disease (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematological, or pulmonary) which, according to the investigator´s criteria, may constitute an additional risk to the patient or impair her ability to complete the test. • The patient has a history or evidence of metabolic bone diseases (other than postmenopausal bone loss), which include, but are not limited to, hypoparathyroidism, a recent hyperthyroidism (suppression of the stimulating thyroid hormone within of the six months prior to entering the study), Paget´s bone disease, osteomalacia and renal osteodystrophy. • The patient has a history of cancer except the following: 1) superficial squamous or basal cell carcinoma that has been completely resected; 2) other malignancies completely treated without recurrence or treatment in the last 5 years, except for the following: patients with a history of breast cancer (even with a histological diagnosis of lobular carcinoma in situ), carcinoma of the endometrium, or any other estrogen neoplasm -sensible known or assumed, are excluded regardless of the time elapsed since the treatment or the state of the disease. • The patient receives or received treatment prior to randomization, which could influence their metabolic turnover of bone mass, including: 1) within the last year: estrogen, estrogen analogues (eg, raloxifene, tamoxifen) or anaboli
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The percentage change from baseline to month 6 and month 12 will be analyzed. The percentage change evaluated at month 12 will be considered the main end point. Measure:Percentage change from the baseline to month 12 in Spinal bone mineral density Timepoints:Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Dual energy x-ray absorptiometry (DXA) of the hip and lumbar spine PA, performed using Lunar and Hologic instrumentation. Measure:The percentage changes from the baseline to month 12 in the bone mineral density of the total hip and the hip trochanter. Timepoints:Month 12 ; Outcome name:All increment response from the baseline and an increase of at least 3% in the bone mineral density of the lumbar spine will be evaluated. The percentage of patients who respond will be analyzed. Measure:The response to treatment at month 12. Timepoints:Month 12 ; Outcome name:Measurement of biochemical markers (urinary NTx and serum BSAP) Measure:The percent change from baseline to month 6 and month 12 in biochemical markers (urinary NTx and serum BSAP) Timepoints:Month 6 and 12 ; Outcome name:Record of adverse experiences Measure:Percentage of patients with any adverse experience Timepoints:When the adverse experience appears | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed