nderstanding the mechanism of the acute phase response following intravenous (IV) bisphosphonates and its prevention: a study of the effects of zoledronic acid and co-prescription with fluvastatin or placebo

Completed

• Conditions: Osteopenia/ osteoporosis; Musculoskeletal Diseases; Postmenopausal osteoporosis

• Registration Number: ISRCTN37909269
• Lead Sponsor: niversity of Aberdeen (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 60

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 <= 10 years post menopause
2. Bisphosphonate naïve women with osteopenia as defined by the World Health Organization (WHO) (T-score <= 1.0 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

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 <= 3 cm with no nodal or local invasion) which has been completely treated more than one year ago with no evidence of recurrence
6.3. Other malignancies completely treated without recurrence or treatment in the last 5 years
7. Baseline renal insufficiency defined as either baseline creatinine of >177 mmol/l and/or calculated creatinine clearance of < 40ml/min
8. Serum 25-OH vitamin D level <15 ng/ml
9. Serum calcium <2 mmol/L and >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 <= 1 week is acceptable. Topical (vaginal) oestrogen cream (<= 2 g) used up to two times weekly is acceptable
11.3. Thyroid hormone, unless on a stable dose for at least six weeks before randomisation with serum TSH within the normal range; patients found at screening to have mild hypothyroidism (as indicated by an elevation in TSH to no more than 15 µIU/ml) are eligible to enter the study provided they receive careful thyroid replacement therapy, if needed, and TSH levels are monitored three months later and as appropriate during the study
11.4. Glucocorticoid treatment for more than one month with >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified