Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects. Subtitle: A 2-year randomised parallel group trial of alendronate, ibandronate and risedronate for postmenopausal osteoporosis in secondary care. - TRIO

Phase 1

• Conditions: Osteoporosis; MedDRA version: 8.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausal

• Registration Number: EUCTR2006-004738-33-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-30
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

be female
at least 5 years post menopausal but <85 years
BMD T-score (at the lumbar spine or total hip) of less than -2.5, or T-score less than -1 with a low trauma fracture.
be ambulatory
be able and willing to participate in the study and provide written informed consent

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) yes
F.1.3.1 Number of subjects for this age range

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
oBisphosphonates (at any dose)
oUse of any fluoride with the exception use for oral hygiene
oStrontium
oOther 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified