This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,609
2.5mg po daily
100mg po monthly on a single day
100mg po monthly over 2 consecutive days
Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
Time frame: From Baseline (Month 0) to Month 12
Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.
Time frame: From Baseline (Month 0) to Month 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
The absolute change (g/cm\^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.
Time frame: From Baseline (Month 0) to Months 12 and 24
Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.
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150mg po monthly
500 mg/day
400 IU/day
Unnamed facility
Irvine, California, United States
Unnamed facility
Loma Linda, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Rancho Mirage, California, United States
Unnamed facility
Lakewood, Colorado, United States
Unnamed facility
Gainesville, Florida, United States
Unnamed facility
Bethesda, Maryland, United States
Unnamed facility
Wheaton, Maryland, United States
Unnamed facility
St Louis, Missouri, United States
...and 58 more locations
Time frame: From Baseline (Month 0) to Months 12 and 24
Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center
Time frame: From Baseline (Month 0) to Months 12 and 24
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.
Time frame: Months 12 and 24
Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Time frame: From Baseline (Month 0) to Months 3, 6, 12, 24
Absolute Change In Baseline in Serum CTX to Months 12 and 24
Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Time frame: From Baseline (Month 0) to Months 12 and 24
Number of Participants With Any Adverse Events and Serious Adverse Event
An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time frame: Up to Month 24
Number Of Participants With Marked Laboratory Abnormalities
Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter \[g/L\]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10\*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter \[mmol/L\]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter \[umol/L\].
Time frame: Up to Month 24