Impact of Oral Ibandronate 150mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)
Information source: Charite University, Berlin, Germany
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis, Postmenopausal
Intervention: oral ibandronate 150 mg monthly (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s):
Dieter Felsenberg, Prof. Dr., Principal Investigator, Affiliation: Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany
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 structural bone parameters which determine bone strength and predict fracture risk
earlier and more precisely are measurable in vivo by 3DpQCT.
Safety:
To assess the tolerability and safety of ibandronate therapy
Clinical Details
Official title: Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 60 Years.
Maximum age: 75 Years.
Gender(s): Female.
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
Locations and Contacts
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin 12200, Germany
Additional Information
Homepage of the Centre for Muscle and Bone Research
Starting date: March 2006
Ending date: September 2007
Last updated: September 6, 2006
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