Status:
COMPLETED
Resolution of Effect of Bisphosphonates on Bone in Postmenopausal Osteoporosis
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
University of Sheffield
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
Up to 87 years
Brief Summary
This is a 2year observational study that will recruit patients who have previously completed a randomised, open label, parallel, single centre study (TRIO Study) of three bisphosphonates: alendronate,...
Detailed Description
The current study is an observational study aiming to compare the effects of stopping medication on bone quantity and quality, in patients who have previously taken bisphosphonate drugs for a duration...
Eligibility Criteria
Inclusion
- Inclusion Criteria for postmenopausal women
- female be at least 7 years postmenopausal but less than 87 years of age
- be ambulatory
- be able and willing to participate in the study and provide written informed consent.
- have taken a bisphosphonate for 2 years as a participant in the TRIO study and be compliant \> 80%
- have a Bone Mineral Density (BMD) T score \> -2.5 at the femoral neck
- Inclusion Criteria for premenopausal women
- be able and willing to participate in the study and provide written informed consent
- have previously taken part as premenopausal controls in the TRIO study
- be in good general health as determined by past medical and physical history
- be bisphosphonate naive; premenopausal women.
Exclusion
- Exclusion Criteria for postmenopausal women:
- An incident vertebral fracture or more than 5%/year bone loss at the spine or hip during the 2-year TRIO study
- Evidence of a clinically significant organic disease which could prevent the patient from completing the study, including diabetes
- Abuse of alcohol or use of illicit drugs or who consumed more than 4 units of any alcoholic beverage one day prior to the visit (i.e. subjects who might be binge drinkers)
- A history of cancer within the past 5 years excluding skin cancer non melanomas
- 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 Thyrotrophin-stimulating hormone (TSH) outside the lower limit of the normal range
- Hyperparathyroidism
- Hypocalcemia or hypercalcemia
- Osteomalacia
- Cushing's syndrome
- Current use of glucocorticoid therapy
- A serum calcium less than 2.2 mmol/l and a Parathyroid hormone (PTH) above 75ng/l
- A history of any known condition that would interfere with the assessment of Dual-emission X-ray absorptiometry (DXA) at either lumbar spine or femoral neck
- Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the principal investigator
- Require, in the opinion of the consulting physician, continuation of bisphosphonate therapy.
- Exclusion Criteria for premenopausal women:
- Are pregnant or nursing (lactating)
- Use of any hormonal forms of contraception/ therapy within the past 2 years that would, in the opinion of the consulting physician, affect bone metabolism.
- Use of anabolic agents such as steroids or PTH, or any bisphosphonate within the past 2 years.
- Have any history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the patient has been in remission for at least 6 months prior to enrolment.
- Have any chronic disease (HIV or AIDs, clinically significant renal or cardiovascular disease, hyperthyroidism, diabetes, hyperlipidemia) or menstrual cycle irregularity (by history)).
- Have any metabolic bone disease, such as osteoporosis, Paget 's disease, osteogenesis imperfecta, or serious illness affecting normal bone homeostasis (by history and physical exam if required)
- Significant use of any medications known to affect bone metabolism (such as Phenytoin or other anticonvulsants, Selective Estrogen Receptor Modulators (SERMs), heparin or systemic glucocorticosteroids) within the past 2 years.
- Have suffered a fracture within the last 12 months
- Have anorexia nervosa, suspected bulimia (by history or physical) or obvious malnutrition
- Have a history of alcoholism, or who have consumed more than 4 units of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers)
- Have previously participated in active therapy clinical trials within the last 3 months
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01406613
Start Date
March 1 2010
End Date
November 1 2015
Last Update
February 15 2019
Active Locations (1)
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1
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorks, United Kingdom, S5 7AU