Phase 3 N=161 Randomized Quadruple-blind Prevention

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

Osteopenia

Bottom Line

View on ClinicalTrials.gov: NCT00386360 ↗

Enrolled (actual)

161

Serious AEs

7.6%

Results posted

Jan 2012

Primary outcome: Primary: Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12 — -1.486; -1.255 Percent Change — p=0.7096

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Placebo comparator (Drug); risedronate (Drug)
Age: Adult · 40+ yrs
Sex: Female
Sponsor: Warner Chilcott
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12	-1.486; -1.255	0.7096
SECONDARY Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12	-2.121; -1.578	0.2973
SECONDARY Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12	-0.786; -0.301	0.1275
SECONDARY Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12	-1.820; -1.156	0.3360
SECONDARY Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12	-0.440; -0.106	0.4565
SECONDARY Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12	-0.784; -0.173	0.0614
SECONDARY Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12	0.785; 0.725	0.9212
SECONDARY Lumbar Spine BMD, Percent Change From Baseline to Month 12	-1.797; 1.473	<0.0001 sig
SECONDARY Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12	-0.976; 0.468	<0.0001 sig
SECONDARY Femoral Neck BMD, Percent Change From Baseline to Month 12	-1.422; -0.014	0.0036 sig
SECONDARY Greater Trochanter BMD, Percent Change From Baseline to Month 12	-0.462; 0.996	0.0087 sig
SECONDARY Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12	1.537; -38.002	0.0002 sig
SECONDARY Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12	-5.762; -46.031	<0.0001 sig
SECONDARY Height, Percent Change From Baseline to Month 12	-0.163; -0.071	0.1385

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.

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;

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00386360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.