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

Inclusion criteria

• Age between 60 and 75 years
• Menopause > 5 years
• Spine (L1 - L4) or hip BMD ≤ -2.0 and > -3.5 SD T-score measured by DXA
• Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration
• Written informed consent
• 3DpQCT measurable at both skeletal sites, distal tibia and radius

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