Trial record 5 of 171 for:
"Osteoporosis, Postmenopausal"
Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)
This study has been completed.
Sponsor:
Charite University, Berlin, Germany
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00271713
First received: January 3, 2006
Last updated: January 27, 2009
Last verified: January 2009
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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: ibandronate, calcium and vitamin D Drug: placebo,calcium and vitamin D |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150 mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures |
Resource links provided by NLM:
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- BV/TV and trab. Sp. measured by 3D pQCT device [ Time Frame: Baseline and after 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 70 |
| Study Start Date: | March 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: ibandronate
150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily
|
Drug: ibandronate, calcium and vitamin D
1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or
|
|
Placebo Comparator: 2
placebo monthly plus 500mg calcium and 800 UI vitamin D daily
|
Drug: placebo,calcium and vitamin D
2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily
|
Eligibility| Ages Eligible for Study: | 60 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271713
Locations
| Germany | |
| Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin | |
| Berlin, Germany, 12200 | |
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
| Principal Investigator: | Dieter Felsenberg, Prof. Dr. | Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany |
More Information
Additional Information:
No publications provided
| Responsible Party: | Charite University, Berlin, Germany, center for muscle and bone research |
| ClinicalTrials.gov Identifier: | NCT00271713 History of Changes |
| Other Study ID Numbers: | ML 19472 |
| Study First Received: | January 3, 2006 |
| Last Updated: | January 27, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
bone structure ibandronate |
Additional relevant MeSH terms:
|
Osteoporosis, Postmenopausal Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Ibandronic acid Calcium, Dietary Vitamin D |
Ergocalciferols Diphosphonates Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013