Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)
Osteoporosis, Postmenopausal
About this trial
This is an interventional treatment trial for Osteoporosis, Postmenopausal focused on measuring bone structure, ibandronate
Eligibility Criteria
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
Sites / Locations
- Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
ibandronate
2
150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily
placebo monthly plus 500mg calcium and 800 UI vitamin D daily