osteoporosis cardiovascular disease
Conditions
Interventions
Trade Name: risedronate
Product Name: risedronate
Pharmaceutical Form: Capsule*
INN or Proposed INN: risedronate
CAS Number: 115436-72-1
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Greenpark Healthcare Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed