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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - ELISA / enzyme-linked immunosorbent assay method by central lab
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 - Electrochemiluminescence assay method by central lab
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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
Other publications