Osteoporosis MedDRA version: 8.1 Level: PT Classification code 10031285 Term: Osteoporosis postmenopausal
Conditions
Interventions
Trade Name: Fosamax
Pharmaceutical Form: Tablet
INN or Proposed INN: ALENDRONIC ACID
CAS Number: 66376361
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 70-
Trade
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: be female at least 5 years post menopausal but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be admitted to the study if they exhibit any of the following: • have evidence of a clinically significant organic disease which could prevent the patient from completing the study • have a BMI less than 18 or greater than 35 • abuse alcohol or use illicit drugs • have any history of cancer within the past 5 years excluding skin cancer non melanomas • have a history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health (secondary osteoporosis) • Chronic renal disease (as defined by a creatinine clearance of = 30ml/min) • Acute or chronic hepatic disease • Malabsorption syndromes • Hyperthyroidism as manifested by TSH outside the lower limit of the normal range • Hyperparathyroidism • Hypocalcemia or hypercalcemia • Osteomalacia • Cushing’s syndrome • Patient who are currently on glucocorticoid therapy • have a serum calcium less than 2.2 mmol/l and a PTH above 75ng/l • have a history of any known condition that would interfere with the assessment of DXA at either lumbar spine or femoral neck • have markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the Investigator • use any of the following medications within 12 months of starting study drug o Bisphosphonates (at any dose) o Use of any fluoride with the exception use for oral hygiene o Strontium o Other bone agents (i.e., SERM, isoflavones etc) • have participated in another clinical trial involving active therapy 3 months prior to randomisation • have a history of allergic reaction to bisphosphonates • patient taking calcium supplements within the last month prior to randomisation • We will exclude patients with secondary osteoporosis, those who have been on anti-resorptive treatments in the past year, and women less than 5 years since menopause, and those with bilateral fractures in the measurement regions (heel, hip and forearm). • Have suffered a recent fracture within the last 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do the three licensed bisphosphonates (alendronate, ibandronate and risedronate) affect the peripheral skeleton differently, as assessed by quantitative ultrasound of bone (QUS), peripheral quantitative computed tomography (pQCT) and dual energy x-ray absorptiometry (DXA)? ;Secondary Objective: Do the three licensed bisphosphonates (alendronate, ibandronate and risedronate) have different effects on bone cells and their activity as assessed by flow cytometry and biochemical markers of bone cell activity?;Primary end point(s): The primary endpoint will be change in heel Broadband ultrasound attenuation (BUA) which reflects bone density and micro-architecture. | — |
Countries
United Kingdom
Outcome results
None listed