Status:
COMPLETED
Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
Procter and Gamble
University of Sheffield
Conditions:
Post-menopausal Osteoporosis
Eligibility:
FEMALE
35-85 years
Phase:
PHASE2
Brief Summary
A study to determine if the three licensed bisphosphonates (alendronate, ibandronate and risedronate):a) affect the peripheral skeleton differently, as assessed by quantitative ultrasound of bone (QUS...
Detailed Description
There have been a number of randomised controlled trials examining the effect of bisphosphonates on fracture risk. The results of these trials have not been uniform, especially in relation to non-vert...
Eligibility Criteria
Inclusion
- be female
- at least 5 years post menopausal but \<85 years
- BMD T-score (at the lumbar spine or total hip) of less than or equal to
- 5, or T-score less than or equal to -1 with a low trauma fracture.
- be ambulatory
- be able and willing to participate in the study and provide written informed consent
Exclusion
- 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 or who consumed more than 4 servings of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers)
- 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
- Bisphosphonates (at any dose)
- Use of any fluoride with the exception use for oral hygiene
- Strontium
- Other bone agents (i.e., SERM, isoflavones, HRT 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00666627
Start Date
April 1 2007
End Date
December 1 2014
Last Update
March 6 2018
Active Locations (1)
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1
Academic Unit of Bone Metabolism (Sheffield)
Sheffield, South Yorkshire, United Kingdom, S5 7AU