Osteopenia/ osteoporosis Musculoskeletal Diseases Postmenopausal osteoporosis
Conditions
Interventions
The participants will be randomly allocated to the following three arms:
Arm 1: Oral fluvastatin (40 mg immediate release formulation) immediately prior to an intravenous (iv) infusion of zoledronic
Sponsors
University of Aberdeen (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women over the age of 20 and more than 12 months after cessation of menses or with serum estradiol and/or follicle stimulating hormone (FSH) levels consistent with a post-menopausal state, but -2.5) or osteoporosis as defined by the WHO (T-score <-2.5) at the lumbar spine or total hip Bone Mineral Density (BMD) measurement sites 3. Women willing and able to give informed consent
Exclusion criteria
Exclusion criteria: 1. The patient has a history of hypersensitivity to any statin or previously exposed to fluvastatin 2. The patient has a history of any illness or has significant abnormalities on pre-study clinical or laboratory evaluation which, in the opinion of the investigator, might either pose an unacceptable risk to the patient from participation in this study or complicate the interpretation of study data 3. The patient is a current user of any illicit drugs or has a history of drug or alcohol abuse within the past five years 4. The patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss) including but not limited to vitamin D deficiency, hypoparathyroidism, primary hyperparathyroidism, recent hyperthyroidism (suppressed thyroid stimulating hormone [TSH] within the six months prior to entry into the study), Paget's disease of bone, osteomalacia or renal osteodystrophy 5. The patient has any other disease potentially associated with increased bone turnover including, but not exclusive to, rheumatoid arthritis, Crohn's disease, severe renal impairment or severe hepatic disease 6. The patient has a history of cancer except for the following: 6.1. Superficial basal or squamous cell carcinoma of the skin which has been completely resected 6.2. Stage I breast cancer (lesion 177 mmol/l and/or calculated creatinine clearance of 2.75 mmol/L 10. Serum alkaline phosphatase >1.5x Upper Limit of Normal (ULN) and/or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 x ULN 11. The patient is receiving or has received treatment prior to randomisation which might influence bone turnover, including: 11.1. Any treatment with parathyroid hormone during the year prior to randomisation 11.2. Within the last 6 months: oestrogen, oestrogen analogues (e.g., raloxifene, tamoxifen), tibolone or anabolic steroids. Oestrogen taken >3 months ago for 7.5 mg of oral prednisone (or the equivalent) per day within six months prior to randomisation; high-dose, intravenously within 6 months prior to randomisation; patients who have received therapeutic glucocorticoids in the past must be considered highly unlikely to require retreatment (with >7.5 mg of oral prednisone daily or the equivalent for more than one month or <= 500 mg of methylprednisolone pulse at any time) during the course of the study 12. Treatment with an immunosuppressant (e.g., cyclosporine, azathioprine) within the previous year 13. The patient is receiving or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum C reactive protein (CRP) at 72 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in cytokines (tumour necrosis factor-alpha [TNF-alpha], interleukin-6 [IL-6] and interferon gamma) at 24 hours 2. Changes in serum cholesterol at 48 hours 3. Alterations in temperature post infusion (at 24 hours) 4. Alterations in acute phase response as assessed by questionnaire at 72 hours | — |
Countries
United Kingdom
Outcome results
None listed