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

Recruitment & Eligibility

Status: Complete: follow up continuing

Sex: Not specified

Target Recruitment: Not specified

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
metabolism
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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage reduction of the serum concentrations of selected bone turnover markers.<br>1) CTX (carboxy terminal telopeptide of collagen type I), <br>2) PINP (procollagen type I N-terminal pro-peptide)<br> [At the baseline and at 24th week after the commencement of the intervention.]<br>

Secondary Outcome Measures

Name	Time	Method
Tolerability measured by the rate of dropouts due to the adverse effects of alendronate<br><br>Adverse effects of medications - upper GI tract symptoms (i.e. abdominal pain, nausea, vomiting [At the 24th week after commencement of the intervention.]<br>