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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:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Risedronic acid
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014