Vascular Pleiotrophic Effects of Bisphosphonates in Post Menopausal Women with Osteoporosis: Cellular Mechanisms and Functional Consequences - vascular Effects of Bisphosphonates in osteoporosis
- Conditions
- osteoporosiscardiovascular disease
- Registration Number
- EUCTR2007-004529-57-GB
- Lead Sponsor
- Greenpark Healthcare Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:
•Postmenopausal women aged 45 to 60 years of age.
•T score at or below -2.5 standard deviations of the mean on DEXA scan.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria:
• Women who are pregnant, lactating, not undertaking an acceptable form of contraception, have hypocalcaemia or severe renal impairment (a creatinine clearance less than 30ml/min)
•Menopause before the age of 40 or surgical menopause.
•Bone disorders other than osteoporosis.
•Treatment within six months of study entry with androgen, calcitonin, estrogen, progesterone, fluoride in a tablet form, raloxifene, tamoxifen, lithium or anticonvulsants
•Previous treatment with bisphosphonates or steroids.
•Systolic blood pressure of >140 mm Hg or diastolic blood pressure >90 mm Hg at baseline screening examination determined as a mean of 3 readings.
•History of myocardial infarction, angina, peripheral vascular disease, cerebrovascular disease or diabetes mellitus (fasting blood sugar >7.0mmol/l).
•History of gastritis or gastro-oesophageal reflux disease.
•Significant co-morbidity, malignancy or secondary causes of osteoporosis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: We aim to determine whether one of the most commonly prescribed drugs for osteoporosis; bisphosphonates; also confer beneficial cardiovascular effects through effects on the cholesterol synthesis pathway;Secondary Objective: This study aims to clarify if impaired endothelial function; an important step in coronary heart disease; contributes to increased cardiovascular risk in postmenopausal women with osteoporosis;Primary end point(s): Primary outcomes: significant increase in platelet NO bioavailability and decrease in O2- production. Secondary outcomes: increased vascular reactivity and endothelium dependant vasodilatation, down regulation of Rac and Rho activity, NO synthase and NAD(P)H oxidase: reduced platelet activation, and reduction in serial measurements of bone markers
- Secondary Outcome Measures
Name Time Method