Osteoporosis
Conditions
Keywords
Osteoporosis, Post-menopausal, Bone mineral density
Brief summary
This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.
Interventions
DRUGRaloxifene
DRUGZoledronic acid
DRUGPlacebo oral pills
DRUGPlacebo intravenous (i.v.) infusion
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Females, between 45 and 80 years (inclusive) of age, considered post-menopausal according to one of the following guidelines: * Cessation of menses for 18 months in women \< 50 years of age * Cessation of menses for 12 months in women age 50 years or over * Documented bilateral oophorectomy at least 1 year previously * Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to screening, and clinically indicated for treatment with bisphosphonates (BPs) for osteopenia or osteoporosis * Signed informed consent prior to initiation of any study procedure
Exclusion criteria
* Prior treatment with i.v. bisphosphonates within the last 2 years * Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks\*). * \*NOTE: If used less than 8 weeks, the washout period is 6 months. * Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization. * Any treatment with strontium renalate, sodium fluoride or parathyroid hormone * Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of oral prednisone or equivalent for a period of three months or more within the previous year * Treatment with any investigational drug within 30 days prior to randomization * Any woman of child bearing potential * Patients with fractures occurring within three months prior to randomization * History of hypersensitivity to bisphosphonates * History of non-traumatic uveitis or iritis, within 2 years prior to study entry. * A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed. * Previous major solid organ transplant recipient or on a transplant waiting list * History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis * Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months * Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial * Active dental infection, unhealed dental extraction or planned oral surgery within 3 month prior to randomization. * Calculated creatinine clearance \< 30 mL/min * Greater than 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart). * Serum calcium \> 2.75 mmol/L (11.0 mg/dL) or \< 2.08 mmol/L (8.3 mg/dL) at screening * AST, ALT or serum alkaline phosphatase greater than twice the upper limit of normal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Baseline and 6 months | The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Urine NTx at 4 Months | Baseline and 4 months | The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine. |
| Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months | Baseline and 2 months | — |
| Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months | Baseline and 4 months | — |
| Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline and 6 months | — |
| Change From Baseline in Urine NTx at 2 Months | Baseline and 2 months | The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine. |
| Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Immediately after infusion procedure | The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: not at all, a little, somewhat, quite, or completely. |
| Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Immediately after infusion procedure | Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: not at all, a little, somewhat, quite, or completely. |
| Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | At 6 month visit | At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: once a year i.v. infusion, once daily pill, or both are equal. |
| Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Immediately after infusion procedure | The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: not at all, a little, somewhat, quite, or completely. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zoledronic Acid Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group) | 56 |
| Raloxifene Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group) | 53 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative Problems | 0 | 1 |
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Zoledronic Acid | Raloxifene | Total |
|---|---|---|---|
| Age Continuous | 58.8 years STANDARD_DEVIATION 6.97 | 61.5 years STANDARD_DEVIATION 8.2 | 60.1 years STANDARD_DEVIATION 7.68 |
| Age, Customized >=65 years | 13 participants | 18 participants | 31 participants |
| Age, Customized Between 45 and 65 years | 43 participants | 35 participants | 78 participants |
| Post-menopausal | 12.5 year STANDARD_DEVIATION 8.94 | 13.4 year STANDARD_DEVIATION 9.17 | 13.0 year STANDARD_DEVIATION 9.03 |
| Sex: Female, Male Female | 56 Participants | 53 Participants | 109 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 31 / 56 | 13 / 53 |
| serious Total, serious adverse events | 1 / 56 | 1 / 53 |
Outcome results
Primary
Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)
The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
Time frame: Baseline and 6 months
Population: The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid | Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Baseline (n = 52, 53) | 49.054 nM BCE/mM Cr | Standard Deviation 20.4515 |
| Zoledronic Acid | Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | 6 months (n = 49, 47) | 23.676 nM BCE/mM Cr | Standard Deviation 11.9152 |
| Zoledronic Acid | Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Change from baseline to Month 6 (n= 48, 47) | -24.646 nM BCE/mM Cr | Standard Deviation 13.9893 |
| Raloxifene | Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Baseline (n = 52, 53) | 44.460 nM BCE/mM Cr | Standard Deviation 23.2789 |
| Raloxifene | Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | 6 months (n = 49, 47) | 34.183 nM BCE/mM Cr | Standard Deviation 16.4667 |
| Raloxifene | Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.) | Change from baseline to Month 6 (n= 48, 47) | -8.362 nM BCE/mM Cr | Standard Deviation 15.3852 |
Secondary
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months
Time frame: Baseline and 2 months
Population: The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months | Baseline (n= 50, 48) | 30.104 U/L | Standard Deviation 10.8868 |
| Zoledronic Acid | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months | At Month 2 (n= 51, 51) | 20.855 U/L | Standard Deviation 5.8499 |
| Zoledronic Acid | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months | Change from baseline to Month 2 (n= 47, 46) | -8.947 U/L | Standard Deviation 6.4181 |
| Raloxifene | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months | Baseline (n= 50, 48) | 27.094 U/L | Standard Deviation 9.4039 |
| Raloxifene | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months | At Month 2 (n= 51, 51) | 26.424 U/L | Standard Deviation 7.8699 |
| Raloxifene | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months | Change from baseline to Month 2 (n= 47, 46) | -1.085 U/L | Standard Deviation 4.0969 |
Secondary
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months
Time frame: Baseline and 4 months
Population: The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months | Baseline (n= 50, 48) | 30.104 U/L | Standard Deviation 10.8868 |
| Zoledronic Acid | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months | At Month 4 (n= 49, 47) | 18.218 U/L | Standard Deviation 5.1846 |
| Zoledronic Acid | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months | Change from baseline to Month 4 (n= 45, 42) | -11.442 U/L | Standard Deviation 7.8097 |
| Raloxifene | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months | Baseline (n= 50, 48) | 27.094 U/L | Standard Deviation 9.4039 |
| Raloxifene | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months | At Month 4 (n= 49, 47) | 25.111 U/L | Standard Deviation 8.453 |
| Raloxifene | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months | Change from baseline to Month 4 (n= 45, 42) | -2.000 U/L | Standard Deviation 5.0356 |
Secondary
Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months
Time frame: Baseline and 6 months
Population: The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline (n= 50, 48) | 30.104 U/L | Standard Deviation 10.8868 |
| Zoledronic Acid | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months | At Month 6 (n= 51, 47) | 19.237 U/L | Standard Deviation 5.5181 |
| Zoledronic Acid | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months | Change from baseline to Month 6 (n= 47, 42) | -10.572 U/L | Standard Deviation 7.3263 |
| Raloxifene | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months | Baseline (n= 50, 48) | 27.094 U/L | Standard Deviation 9.4039 |
| Raloxifene | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months | At Month 6 (n= 51, 47) | 24.981 U/L | Standard Deviation 7.9932 |
| Raloxifene | Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months | Change from baseline to Month 6 (n= 47, 42) | -2.250 U/L | Standard Deviation 7.1307 |
Secondary
Change From Baseline in Urine NTx at 2 Months
The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
Time frame: Baseline and 2 months
Population: The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid | Change From Baseline in Urine NTx at 2 Months | Baseline (n= 52, 53) | 49.054 nM BCE/mM Cr | Standard Deviation 20.4515 |
| Zoledronic Acid | Change From Baseline in Urine NTx at 2 Months | At Month 2 (n= 54, 50) | 17.774 nM BCE/mM Cr | Standard Deviation 9.1107 |
| Zoledronic Acid | Change From Baseline in Urine NTx at 2 Months | Change from baseline to Month 2 (n= 52, 50) | -31.065 nM BCE/mM Cr | Standard Deviation 16.496 |
| Raloxifene | Change From Baseline in Urine NTx at 2 Months | Baseline (n= 52, 53) | 44.460 nM BCE/mM Cr | Standard Deviation 23.2789 |
| Raloxifene | Change From Baseline in Urine NTx at 2 Months | At Month 2 (n= 54, 50) | 40.756 nM BCE/mM Cr | Standard Deviation 23.37 |
| Raloxifene | Change From Baseline in Urine NTx at 2 Months | Change from baseline to Month 2 (n= 52, 50) | -4.000 nM BCE/mM Cr | Standard Deviation 11.2757 |
Secondary
Change From Baseline in Urine NTx at 4 Months
The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
Time frame: Baseline and 4 months
Population: The intent-to-treat (ITT) population consisted of all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of the primary efficacy variable of urine N-telopeptide of Type 1 collagen (NTx).Observed cases were used, no imputation was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoledronic Acid | Change From Baseline in Urine NTx at 4 Months | Baseline (n= 52 , 53) | 49.054 nM BCE/mM Cr | Standard Deviation 20.4515 |
| Zoledronic Acid | Change From Baseline in Urine NTx at 4 Months | At Month 4 (n= 48, 46) | 20.802 nM BCE/mM Cr | Standard Deviation 13.1632 |
| Zoledronic Acid | Change From Baseline in Urine NTx at 4 Months | Change from baseline to Month 4 (n= 47, 46) | -27.832 nM BCE/mM Cr | Standard Deviation 15.4142 |
| Raloxifene | Change From Baseline in Urine NTx at 4 Months | Baseline (n= 52 , 53) | 44.460 nM BCE/mM Cr | Standard Deviation 23.2789 |
| Raloxifene | Change From Baseline in Urine NTx at 4 Months | At Month 4 (n= 48, 46) | 38.143 nM BCE/mM Cr | Standard Deviation 24.9307 |
| Raloxifene | Change From Baseline in Urine NTx at 4 Months | Change from baseline to Month 4 (n= 47, 46) | -3.920 nM BCE/mM Cr | Standard Deviation 17.1348 |
Secondary
Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire
The study coordinator (nurse) was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: not at all, a little, somewhat, quite, or completely.
Time frame: Immediately after infusion procedure
Population: Intention-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoledronic Acid | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Quite | 4 Participants |
| Zoledronic Acid | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Not at all / A little / Somewhat | 0 Participants |
| Zoledronic Acid | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Completely | 29 Participants |
| Zoledronic Acid | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Missing | 21 Participants |
| Raloxifene | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Missing | 15 Participants |
| Raloxifene | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Not at all / A little / Somewhat | 0 Participants |
| Raloxifene | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Quite | 3 Participants |
| Raloxifene | Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire | Completely | 35 Participants |
Secondary
Overall Patient Satisfaction Assessed by Satisfaction Questionnaire
Patients were asked to complete the satisfaction questionnaire at baseline. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: not at all, a little, somewhat, quite, or completely.
Time frame: Immediately after infusion procedure
Population: Intention-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoledronic Acid | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Not at all | 1 Participants |
| Zoledronic Acid | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Somewhat | 1 Participants |
| Zoledronic Acid | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | A little | 0 Participants |
| Zoledronic Acid | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Quite | 9 Participants |
| Zoledronic Acid | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Completely | 43 Participants |
| Zoledronic Acid | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Missing | 0 Participants |
| Raloxifene | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Completely | 42 Participants |
| Raloxifene | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Quite | 7 Participants |
| Raloxifene | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Somewhat | 1 Participants |
| Raloxifene | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Not at all | 1 Participants |
| Raloxifene | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | Missing | 1 Participants |
| Raloxifene | Overall Patient Satisfaction Assessed by Satisfaction Questionnaire | A little | 1 Participants |
Secondary
Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire
The investigator was asked to complete satisfaction questionnaires at baseline (Visit 2/Day 1) when each patient's i.v. drug administration occurred. The questionnaire assessed overall satisfaction with the i.v. infusion procedure. The possible answers to the question were: not at all, a little, somewhat, quite, or completely.
Time frame: Immediately after infusion procedure
Population: Intention-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoledronic Acid | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Somewhat | 3 Participants |
| Zoledronic Acid | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Completely | 16 Participants |
| Zoledronic Acid | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Quite | 2 Participants |
| Zoledronic Acid | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Missing | 33 Participants |
| Zoledronic Acid | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Not at all / A little | 0 Participants |
| Raloxifene | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Missing | 38 Participants |
| Raloxifene | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Not at all / A little | 0 Participants |
| Raloxifene | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Somewhat | 1 Participants |
| Raloxifene | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Quite | 3 Participants |
| Raloxifene | Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire | Completely | 11 Participants |
Secondary
Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens
At the end-of-study visit, Month 6, patients were asked to complete a questionnaire to assess preference for the different treatment modalities (annual i.v. infusion vs. daily oral capsule). The possible answers to question were: once a year i.v. infusion, once daily pill, or both are equal.
Time frame: At 6 month visit
Population: Intention-to-treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoledronic Acid | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | Both are equal | 3 Participants |
| Zoledronic Acid | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | Once a year intravenous infusion | 47 Participants |
| Zoledronic Acid | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | Missing | 1 Participants |
| Zoledronic Acid | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | Once daily pill | 3 Participants |
| Raloxifene | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | Missing | 0 Participants |
| Raloxifene | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | Once a year intravenous infusion | 46 Participants |
| Raloxifene | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | Both are equal | 3 Participants |
| Raloxifene | Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens | Once daily pill | 4 Participants |