SLCTR/2018/038Completed未知
Effect of alendronate and vitamin D on selected bone turnover markers in women with postmenopausal osteoporosis and a high fracture risk; a randomized controlled trial
Not provided0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Newly diagnosed post-menopausal females with high fracture risk.
- •Fracture risk assessment: The fracture risk will be assessed based on FRAX algorithm using clinical risk factors and bone mineral density values. Women with major fracture risk >10% and/or hip fracture risk >3% will be considered to have a high fracture risk.
- •Lekamwasam S, (2013), Sri Lankan FRAX model and country-specific intervention thresholds. Arch Osteoporos;8:148.
Exclusion Criteria
- •1.Females with a history of significant neuroendocrine disorder that affect the BTMs (disorders of
- •thyroid gland like hyperthyroidism and disorders of parathyroid glands such as hyperparathyroidism
- •and hypoparathyroidism)
- •2.Treatment with anticonvulsant, thyroxin and hydrochlorothiazide that affect the vitamin D and calcium
- •3.Chronic kidney disease stage 4 or 5 (when eGFR is less than <30 mL min-1 per 1.73 m2)
- •4.Chronic liver disease (clinically evident)
- •5.Other metabolic or inherited bone diseases other than postmenopausal bone loss including Paget’s
- •disease and osteomalacia
- •6.Rheumatoid arthritis or collagen disease
- •7.Subjects with malignancies
- •8.Immobilized or disabled subjects due to cerebrovascular disease
- •9.Gastric surgery, major gastrointestinal disease that causes significant malabsorption,
- •10.Use of any systemic steroid (prednisolone, dexamethasone or equivalent),
- •11.Use of bisphosphonates within the year directly preceding the study
- •12.Other anti-osteoporotic drugs (selective oestrogen receptor modulators and calcitonin) and calcium,
- •vitamin supplement during the last three months
- •13.Women who have experienced early menopause (before 45 years of age)
- •14.Women who have undergone any therapy which can affect the bone metabolism (hormone
- •replacement therapy andandrogen-stimulating therapy)
- •15.Women who are known to take antipsychotics and antiepileptic sodium valproate
- •16.Fracture during the last one year
- •17.Acute illness at the time of recruitment or during last 3 months
- •18.Allergy for bisphosphonates
Investigators
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