Post Menopausal Osteoporosis
Conditions
Brief summary
This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.
Interventions
DRUGIbandronate
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women newly diagnosed with postmenopausal osteoporosis * Naive to prior bisphosphonate therapy
Exclusion criteria
* Inability to stand or sit upright for at least 60 minutes * Inability to swallow a tablet whole * Hypersensitivity to any component of ibandronate * Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months * Other osteoporosis drug within last 3 months * Malignant disease diagnosed within previous 10 years, except resected basal cell cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) | Baseline, Month 6 | Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX) | Baseline, Month 6 | Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). |
| Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | Baseline, Month 6 | Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). |
| Percent Change From Baseline to Month 6 in Serum Osteocalcin | Baseline, Month 6 | Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). |
| Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP) | Baseline, Month 6 | Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group). |
| Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6 | Month 6 | The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibandronate (Consult Group) Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response. | 154 |
| Ibandronate (Non-consult Group) Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response. | 154 |
| Total | 308 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative | 2 | 1 |
| Overall Study | Adverse Event | 11 | 13 |
| Overall Study | Failure to Return | 3 | 3 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Ibandronate (Consult Group) | Ibandronate (Non-consult Group) | Total |
|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 9.94 | 64.9 years STANDARD_DEVIATION 9.69 | 65.1 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 154 Participants | 154 Participants | 308 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 76 / 308 |
| serious Total, serious adverse events | 17 / 308 |
Outcome results
Primary
Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Time frame: Baseline, Month 6
Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate (All Participants) | Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) | -55.26 percent change | Standard Deviation 57.255 |
Secondary
Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6
The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.
Time frame: Month 6
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate (All Participants) | Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6 | (2) Reduces risk of breaking bone | 64.9 percentage of participants |
| Ibandronate (All Participants) | Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6 | (1) or (2) | 72.1 percentage of participants |
| Ibandronate (All Participants) | Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6 | (1) and (2) | 61.7 percentage of participants |
| Ibandronate (All Participants) | Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6 | (1) Effective in treating osteoporosis | 68.8 percentage of participants |
| Ibandronate (Non-consult Group) | Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6 | (1) Effective in treating osteoporosis | 51.9 percentage of participants |
| Ibandronate (Non-consult Group) | Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6 | (2) Reduces risk of breaking bone | 50.0 percentage of participants |
| Ibandronate (Non-consult Group) | Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6 | (1) and (2) | 46.8 percentage of participants |
| Ibandronate (Non-consult Group) | Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6 | (1) or (2) | 55.2 percentage of participants |
p-value: 0.00295% CI: [6.1, 27.7]Chi-squared, Corrected
p-value: 0.00995% CI: [4, 25.8]Chi-squared, Corrected
p-value: 0.00195% CI: [6.3, 27.5]Chi-squared, Corrected
p-value: 0.0195% CI: [3.9, 25.9]Chi-squared, Corrected
Secondary
Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)
Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Time frame: Baseline, Month 6
Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate (All Participants) | Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP) | -35.34 percent change | Standard Deviation 17.386 |
Secondary
Percent Change From Baseline to Month 6 in Serum Osteocalcin
Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Time frame: Baseline, Month 6
Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate (All Participants) | Percent Change From Baseline to Month 6 in Serum Osteocalcin | -41.51 percent change | Standard Deviation 19.448 |
Secondary
Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Time frame: Baseline, Month 6
Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate (All Participants) | Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) | -58.14 percent change | Standard Deviation 25.334 |
Secondary
Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)
Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).
Time frame: Baseline, Month 6
Population: ITT population observed cases: all participants of ITT population with available data for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ibandronate (All Participants) | Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX) | -45.98 percent change | Standard Deviation 28.421 |