|
In- and exclusion criteria |
| Inclusion criteria |
|
|
| • Women aged 45 to70 years |
| • Natural or surgical menopause = 1 year |
| • T-Score between 0.0 and -2.49 (spine or proximal femur – total or femoral neck, measured by DXA) |
|
|
| Exclusion criteria |
|
|
| • Osteoporosis (T-score = -2.5 in spine or proximal femur – total or femoral neck, measured by DXA) |
| • Severe vertebral fracture, as identified by screening DXA assessment |
| • Any history of metabolic disease that could affect bone metabolism: hyperparathyroidism, osteogenesis imperfecta, Paget's disease, osteomalacia |
| • Thyroid disease (if receiving thyroid hormone replacement, the patients must be euthyroid and on a stable dose of thyroid hormone) |
| • Impaired renal function (estimated creatinine clearance <30 ml/min) |
| • History of previous or active malignancy of any organ system, treated or untreated, within the past 5 years. |
| • History of corticosteroid treatments during 6 months or more, daily dosage >5 mg |
| • BMI < 18 or >30 kg/m2 |
| • Treatments with estrogens, SERMs, tibolone, calcitonin, strontium ranelate, teriparatide or PTH, or oral bisphosphonates in the previous year, if duration > 2 weeks. Treatment with iv bisphosphonates or iv calcitonin of any duration in the previous year |
Richert et al. Trials 2008 9:19 doi:10.1186/1745-6215-9-19 |