Metoclopramide Oral |
Clopra; Maxolon; Octamide; Reclomide; Reglan Oral |
Clinical Trial: Impact of Oral Ibandronate 150mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)
This study is not yet open for patient recruitment.
Verified by Charite University, Berlin, Germany December 2005
|
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Osteoporosis, Postmenopausal | Drug: oral ibandronate 150 mg monthly | Phase IV |
MedlinePlus related topics: Osteoporosis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Expected Total Enrollment: 62
Study start: January 2006; Expected completion: February 2008
Last follow-up: August 2007; Data entry closure: December 2007
Eligibility
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
Location and Contact Information
Germany
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany
Dieter Felsenberg, Prof. Dr., Principal Investigator
Oliver Bock, Dr., Sub-Investigator
Dieter Felsenberg, Prof. Dr., Principal Investigator, Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany
More Information
Last Updated: January 3, 2006
Record first received: January 3, 2006
ClinicalTrials.gov Identifier: NCT00271713
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2006-01-10

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