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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00386360




Registration number
NCT00386360
Ethics application status
Date submitted
9/10/2006
Date registered
11/10/2006
Date last updated
11/01/2012

Titles & IDs
Public title
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
Scientific title
A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)
Secondary ID [1] 0 0
2005040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo comparator
Treatment: Drugs - risedronate

Placebo comparator: Placebo - Placebo dose

Experimental: Risedronate - 35 mg risedronate, orally, once weekly


Treatment: Drugs: Placebo comparator
oral weekly for one year

Treatment: Drugs: risedronate
35 mg risedronate, once a week for one year
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
Timepoint [1] 0 0
Baseline and Month 12
Secondary outcome [1] 0 0
Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Timepoint [1] 0 0
Baseline and Month 12
Secondary outcome [2] 0 0
Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Timepoint [2] 0 0
Baseline and Month 12
Secondary outcome [3] 0 0
Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Timepoint [3] 0 0
Baseline and Month 12
Secondary outcome [4] 0 0
Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Timepoint [4] 0 0
Baseline and Month 12
Secondary outcome [5] 0 0
Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Timepoint [5] 0 0
Baseline and Month 12
Secondary outcome [6] 0 0
Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Timepoint [6] 0 0
Baseline and Month 12
Secondary outcome [7] 0 0
Lumbar Spine BMD, Percent Change From Baseline to Month 12
Timepoint [7] 0 0
Baseline and Month 12
Secondary outcome [8] 0 0
Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12
Timepoint [8] 0 0
Baseline and Month 12
Secondary outcome [9] 0 0
Femoral Neck BMD, Percent Change From Baseline to Month 12
Timepoint [9] 0 0
Baseline and Month 12
Secondary outcome [10] 0 0
Greater Trochanter BMD, Percent Change From Baseline to Month 12
Timepoint [10] 0 0
Baseline and Month 12
Secondary outcome [11] 0 0
Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12
Timepoint [11] 0 0
Baseline and Month 12
Secondary outcome [12] 0 0
Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12
Timepoint [12] 0 0
Baseline and Month 12
Secondary outcome [13] 0 0
Height, Percent Change From Baseline to Month 12
Timepoint [13] 0 0
Baseline and Month 12

Eligibility
Key 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;
Minimum age
40 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
161
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Facility - Heidelberg
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
France
State/province [3] 0 0
Lyon
Country [4] 0 0
France
State/province [4] 0 0
Saint-Etienne
Country [5] 0 0
France
State/province [5] 0 0
Toulouse
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Switzerland
State/province [7] 0 0
Geneva
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Cambridge

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Warner Chilcott
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT00386360
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gioacchino D'Alo, MD
Address 0 0
P&G Pharmaceuticals, Clinical Development Europe
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00386360