Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
This study has been completed.
Sponsor:
Warner Chilcott
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00386360
First received: October 9, 2006
Last updated: December 6, 2011
Last verified: October 2011
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Purpose
The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteopenia |
Drug: Placebo comparator Drug: risedronate |
Phase 3 |
| 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: Prevention |
| Official Title: | A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT) |
Resource links provided by NLM:
Further study details as provided by Warner Chilcott:
Primary Outcome Measures:
- Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Lumbar Spine BMD, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Femoral Neck BMD, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Greater Trochanter BMD, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
- Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]ELISA / enzyme-linked immunosorbent assay method by central lab
- Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]Electrochemiluminescence assay method by central lab
- Height, Percent Change From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
| Enrollment: | 161 |
| Study Start Date: | April 2006 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Placebo dose
|
Drug: Placebo comparator
oral weekly for one year
|
|
Experimental: Risedronate
35 mg risedronate, orally, once weekly
|
Drug: risedronate
35 mg risedronate, once a week for one year
|
Detailed Description:
The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. The primary objective is to evaluate the sensitivity of the technology to detect a difference between those treated with risedronate 35mg OAW (once a week) or placebo. Early phase postmenopausal women with osteopenia have been chosen because they have a more rapid and higher level of bone loss during the first few years of the menopause.
Eligibility| Ages Eligible for Study: | 40 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment;
- osteopenic
- must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
- BMI (body mass index) between 18 and 28 kg/m2 inclusive;
Exclusion Criteria:
- history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of DXA (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine L1 - L4) or the femoral neck.
- clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;
- glucocorticoid-induced osteopenia;
- previous bisphosphonate therapy;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386360
Locations
| Argentina | |
| Research Facility | |
| Buenos Aires, Argentina, C1012AAR | |
| Australia, Victoria | |
| Research Facility | |
| Heidelberg, Victoria, Australia, 3081 | |
| Canada, Ontario | |
| Research Facility | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| France | |
| Research Facility | |
| Lyon, France | |
| Research Facility | |
| Saint-Etienne, France | |
| Research Facility | |
| Toulouse, France | |
| Germany | |
| Research Facility | |
| Berlin, Germany | |
| Switzerland | |
| Research Facility | |
| Geneva, Switzerland | |
| United Kingdom | |
| Research Facility | |
| Cambridge, United Kingdom | |
Sponsors and Collaborators
Warner Chilcott
Investigators
| Principal Investigator: | Gioacchino D'Alo, MD | P&G Pharmaceuticals, Clinical Development Europe |
More Information
No publications provided
| Responsible Party: | Warner Chilcott |
| ClinicalTrials.gov Identifier: | NCT00386360 History of Changes |
| Other Study ID Numbers: | 2005040 |
| Study First Received: | October 9, 2006 |
| Results First Received: | August 12, 2011 |
| Last Updated: | December 6, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices United Kingdom: National Health Service Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Risedronic acid Etidronic Acid Bone Density Conservation Agents Physiological Effects of Drugs |
Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013