Status:
COMPLETED
Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
60-75 years
Phase:
PHASE4
Brief Summary
Efficacy: To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis. Major struct...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00271713
Start Date
March 1 2006
End Date
September 1 2007
Last Update
January 28 2009
Active Locations (1)
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1
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, Germany, 12200