This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is \<100 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
Unnamed facility
Beverly Hills, California, United States
Unnamed facility
La Jolla, California, United States
Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Woodbury, Minnesota, United States
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen Concentration (sCTX) From Baseline to Day 3
Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. It is measured in units of nanograms (ng) per milliliter (mL). The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX time point- sCTX Baseline) / (sCTX Baseline) \* 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.
Time frame: Baseline (Visit 1) and Day 3
Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration From Baseline Over Time
sCTX is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. The relative change in sCTX was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (sCTX Time point- sCTX Baseline) / (sCTX Baseline) \* 100. The sCTX value used for Baseline was the average of the results from the 2 blood samples taken at screening. If 1 of these 2 samples was nonquantifiable or missing, then the Baseline sCTX was the result from the non-missing sample. Baseline visit was defined as Visit 1.
Time frame: Baseline (Visit 1), Day (D) 3, D7, D14, D21, D28 of Month (M)1, M2, M3, M4, M5, M6
Relative Percent Change in Bone Specific Alkaline Phosphatase (BSAP) Concentration From Baseline Over Time
BSAP is a biochemical marker of bone formation and measured in units per litre (U/L). The relative percent change in BSAP was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (BSAP time point- BSAP Baseline) / (BSAP Baseline) \* 100. The greater the percent decrease from Baseline, the greater the response to therapy. Baseline visit was defined as Visit 1.
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Unnamed facility
The Bronx, New York, United States
Unnamed facility
Hopwood, Pennsylvania, United States
Unnamed facility
Madison, Wisconsin, United States
Unnamed facility
Ponce, Puerto Rico
Unnamed facility
San Juan, Puerto Rico
Unnamed facility
San Juan, Puerto Rico
Time frame: Baseline (Visit 1), Day (D) 7 and D 28 of Month (M)1, M2, M3, M4, M5, M6
Relative Percent Change in Parathyroid Hormone (PTH) From Baseline to Post Treatment Assessments
Parathyroid hormone (PTH) regulates calcium and phosphate metabolism in bone and kidney, and is measured in picogram/milliliter (pg/mL). The relative percent change in PTH was defined as the relative difference between the value at each time point and the value at Baseline, using the following formula: Relative change = (PTH time point- PTH Baseline) / (PTH Baseline) \* 100. Post treatment assessments were done at Baseline, Month (M)1 Day (D)7, and M6D7
Time frame: Baseline (Visit 1), Month (M)1 Day (D)7, and M6D7
Percentage of Participants With a Serum C-terminal Telopeptide of Type1 Collagen (sCTX) Concentration Between 0.011 and 0.631 ng/mL and Who Have Achieved a Decrease in sCTX Concentration of at Least 8 Percent
The Cochran-Mantel Haenszel test stratified by Baseline sCTX category was used to compare the 2 treatment groups for proportion of participants whose sCTX concentration was between 0.011 and 0.631 ng/mL (premenopausal normal range mean +/- 2 SD) who achieved a decrease in sCTX of at least 8% from Baseline. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD=0.155 ng/mL. Baseline visit was defined as Visit 1.
Time frame: Baseline (Visit 1) and Day (D)3 of Month (M)1 and; D7, D14, D21, D28 of each M1, M2, M3, M4, M5, and M6
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.476 ng/mL
Percentage of participants whose sCTX concentration was between 0.011 and 0.476 ng/mL (Mean -2 to + 1 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL. Baseline visit was defined as Visit 1.
Time frame: Baseline (Visit 1) and Day (D)3 of M1 and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
Percentage of Participants With a Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentration Between 0.011 and 0.321 ng/mL
Percentage of participants whose sCTX concentration was between 0.011 and 0.321 ng/mL (Mean -2 to + 0 SD) were analyzed at particular time points. Mean and SD are based on the normal range for premenopausal women: Mean = 0.321 ng/mL, SD = 0.155 ng/mL.
Time frame: Baseline (Visit 1), Day (D)3 of M1, and D7, D14, D21, D28 of each M1, M2, M3, M4, M5, M6
Difference Between the Minimum and Maximum Relative Percent Change in Serum C-terminal Telopeptide of Type 1 Collagen (sCTX) Concentrations
Overall minimum and maximum relative percent change in sCTX concentrations from Baseline were calculated for all participants over D7, D14, D21 and D28 of Month 6 and the difference between it was analyzed.
Time frame: Day (D)7, D14, D21 and D28 of Month 6
Number of Participants With Any Marked Abnormality in Laboratory Parameters
Marked laboratory abnormalities are those which exceed the marked abnormality range (i.e., greater or less than the Roche defined marked abnormality range; i.e Low or High) 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 : Hematocrit (0.31- 0.56 fraction), hemoglobin (110 - 200 g/L), platelets (100 - 550 \*10\^9/L), white blood cell (WBC) (3.0 - 18.0 \*10\^9/L), alanine aminotransferase (ALT) (0 - 110 U/L), creatinine (0 - 154 µmol/L), chloride (95 - 115 mmol/L), phosphate (0.75 - 1.60 mmol/L ). Creatinine clearance was calculated using the Cockroft-Gault formula.
Time frame: Up to 7 months
Number of Participants With Any Adverse Event or Serious Adverse Event
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Time frame: Up to 7 months