This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. 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
1,395
2mg iv every 2 months
2.5mg po daily
3mg iv every 3 months
Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
Time frame: Baseline and Month 12
Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)
Time frame: Baseline and Month 24
Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 - L4) at Month 12 and Month 24
BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: Baseline, Month 12 and Month 24
Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
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Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Irvine, California, United States
Unnamed facility
Rancho Mirage, California, United States
Unnamed facility
Leesburg, Florida, United States
Unnamed facility
Gainesville, Georgia, United States
Unnamed facility
Coeur d'Alene, Idaho, United States
Unnamed facility
Bethesda, Maryland, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Billings, Montana, United States
Unnamed facility
Omaha, Nebraska, United States
...and 54 more locations
Time frame: Baseline, Month 12 and Month 24
Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24
BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.
Time frame: Baseline, Month 12 and Month 24
Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed.
Time frame: Baseline, At Month 6, 12, and 24.
Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24
Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: Baseline, At Month 6, 12, and 24.
Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 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. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24
A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 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. Only participants with data available at particular timepoint were analyzed.
Time frame: At Month 12 and 24
Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)
An 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 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: Approximately 2 years
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 - 700 \* 10\^9/L), low and high white blood cell (WBC) (3.0 - 18.0 \* 10\^9/L), high alanine aminotransferase (ALAT) (0 - 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 - 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 - 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 - 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L).
Time frame: Approximately 2 years