Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method

Osteopenia Clinical Trial

Official title:

A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386360
• Other study ID #: 2005040
• Status: Completed
• Phase: Phase 3
• First received: October 9, 2006
• Last updated: December 6, 2011
• Start date: April 2006
• Est. completion date: September 2009

Study information

• Verified date: October 2011
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: National Health ServiceSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia

Intervention

Drug:
• Placebo comparator
oral weekly for one year
• risedronate
35 mg risedronate, once a week for one year

Locations

Country	Name	City	State
Argentina	Research Facility	Buenos Aires
Australia	Research Facility	Heidelberg	Victoria
Canada	Research Facility	Toronto	Ontario
France	Research Facility	Lyon
France	Research Facility	Saint-Etienne
France	Research Facility	Toulouse
Germany	Research Facility	Berlin
Switzerland	Research Facility	Geneva
United Kingdom	Research Facility	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Countries where clinical trial is conducted

Argentina,  Australia,  Canada,  France,  Germany,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Lumbar Spine BMD, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Femoral Neck BMD, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Greater Trochanter BMD, Percent Change From Baseline to Month 12		Baseline and Month 12	No
Secondary	Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12	ELISA / enzyme-linked immunosorbent assay method by central lab	Baseline and Month 12	No
Secondary	Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12	Electrochemiluminescence assay method by central lab	Baseline and Month 12	No
Secondary	Height, Percent Change From Baseline to Month 12		Baseline and Month 12	No