Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)

Exclusion Criteria

• •Spine or hip BMD ≤ -3,5 SD T-Score measured by DXA
• •Vertebral fractures
• •Multiple (\>2) low trauma peripheral fractures
• •Disease/disorder known to influence bone metabolism
• •History of major upper gastro-intestinal (GI) disease
• •Diagnosed malignant disease within the previous 10 years
• •Previous treatment with a bisphoshonate at any time
• •Treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the last 12 months, or for more than 2 years (total duration)
• •Treatment with PTH and similar agents or strontium ranelate at any time
• •Treatment with other drugs affecting bone metabolism within the last 6 months
• •Chronic systemic corticosteroid treatment
• •Estrogens, progestins, SERMs, anabolic steroids, active vitamin D analogues/metabolites, calcitonin
• •Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate
• •Total serum calcium \< 2.2 mmol/l or \> 2.6 mmol/l
• •Vitamin D deficiency (serum 25-hydroxy vitamin D \< 12 ng/ ml)
• •ALT above triple upper limit of normal range
• •Renal impairment (serum creatinine \> 210 µmol/l)
• •Contra-indications for ibandronate, calcium or vitamin D
• •Employees of the Centre for Muscle and Bone Research, or their relatives