Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density
Condition: Osteoporosis
MeSH terms: Osteoporosis; Bone Diseases, Metabolic
Intervention: Raloxifene; Zoledronic acid; Placebo oral pills; Placebo intravenous (i.v.) infusion
Intervention MeSH terms: Zoledronic Acid; Raloxifene Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: Female
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoporosis; Post-menopausal; Bone mineral density

Summary:

      This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone
      turnover markers in postmenopausal women with low bone mineral density over 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females, between 45 and 80 years (inclusive) of age, considered post-menopausal
             according to one of the following guidelines:

          -  Cessation of menses for 18 months in women < 50 years of age

          -  Cessation of menses for 12 months in women age 50 years or over

          -  Documented bilateral oophorectomy at least 1 year previously

          -  Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry
             (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to
             screening, and clinically indicated for treatment with bisphosphonates (BPs) for
             osteopenia or osteoporosis

          -  Signed informed consent prior to initiation of any study procedure

        Exclusion Criteria:

          -  Prior treatment with i.v. bisphosphonates within the last 2 years

          -  Previous use of oral bisphosphonates within the past 2 years (unless used for less
             than 8 weeks*).

          -  *NOTE: If used less than 8 weeks, the washout period is 6 months.

          -  Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The
             washout period for these medications is 6 months prior to randomization.

          -  Any treatment with strontium renalate, sodium fluoride or parathyroid hormone

          -  Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of
             oral prednisone or equivalent for a period of three months or more within the previous
             year

          -  Treatment with any investigational drug within 30 days prior to randomization

          -  Any woman of child bearing potential

          -  Patients with fractures occurring within three months prior to randomization

          -  History of hypersensitivity to bisphosphonates

          -  History of non-traumatic uveitis or iritis, within 2 years prior to study entry.

          -  A history of invasive malignancy of any organ system, treated or untreated, within the
             past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of
             the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal
             Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS)
             of the uterine cervix that has been surgically removed.

          -  Previous major solid organ transplant recipient or on a transplant waiting list

          -  History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's
             disease or any metabolic bone disease other than osteoporosis

          -  Any medical condition which would interfere with the action of the study drug or limit
             life expectancy to less than 6 months

          -  Any medical or psychiatric condition which, in the opinion of the investigator, would
             preclude the participant from adhering to the protocol or completing the trial

          -  Active dental infection, unhealed dental extraction or planned oral surgery within 3
             month prior to randomization.

          -  Calculated creatinine clearance < 30 mL/min

          -  Greater than 2+ protein on urine dipstick without evidence of contamination or
             bacteriuria (may be repeated one time, at least a day apart).

          -  Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.08 mmol/L (8.3 mg/dL) at screening

          -  AST, ALT or serum alkaline phosphatase greater than twice the upper limit of normal