Clinical trial NCT00386360: Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
Official title: A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteopenia
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 161
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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;

Primary outcomes:
measure: Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Lumbar Spine BMD, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Femoral Neck BMD, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Greater Trochanter BMD, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
measure: Height, Percent Change From Baseline to Month 12
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Facility
city: Heidelberg
country: Australia
facility: Research Facility
state: Victoria
city: Toronto
country: Canada
facility: Research Facility
state: Ontario
city: Lyon
country: France
facility: Research Facility
city: Saint-Etienne
country: France
facility: Research Facility
city: Toulouse
country: France
facility: Research Facility
city: Berlin
country: Germany
facility: Research Facility
city: Geneva
country: Switzerland
facility: Research Facility
city: Cambridge
country: United Kingdom
facility: Research Facility
Study officials:
affiliation: P&G Pharmaceuticals, Clinical Development Europe
name: Gioacchino D'Alo, MD
role: PRINCIPAL_INVESTIGATOR
References: