Osteoporosis
Conditions
Keywords
Bone mineral density, bone morphogenetic protein, osteoporosis
Brief summary
The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures of the hip. All subjects will receive standard treatment for low bone mass, consisting of bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly selected to receive treatment with rhBMP-2 will receive an injection directly into the hip. The injection is given in a surgery room using a light anesthesia.
Interventions
DRUGrhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.
DRUGbisphosphonates, calcium, and vitamin D
Oral bisphosphonate therapy
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Community-dwelling, ambulatory (with or without assistive device), postmenopausal females, age greater than 65 years. * BMD T-score (total hip or femoral neck) of -2.5 or less in at least 1 hip. Subjects with BMD T-scores of -2.0 or less may be enrolled if at least one of the following risk factors is also present: * Age greater than 75 years * Family (maternal) history of fragility fracture * Previous fragility fracture (self) after age 45 * Subjects may either be treatment naïve or on a previously-established regimen ( greater than 1year, but less than 5 years duration) of bisphosphonate therapy. Subjects must be willing to comply with 1of the 3 protocol-designated oral bisphosphonates (risedronate, alendronate, or ibandronate sodium) with risedronate considered as first-line therapy.
Exclusion criteria
* Metabolic bone disorder or disease affecting bone and mineral metabolism (eg, Paget's disease, vitamin D deficiency \[ less than 20 ng/mL\], hyperparathyroidism, renal osteodystrophy, osteomalacia, hypocalcemia, hypercalcemia). * Coagulopathy and/or history of venous thromboembolic events (deep vein thrombosis, pulmonary embolus, retinal vein thrombosis) within the past 12 months. * Inflammatory arthritis including rheumatoid, psoriatic, or crystal-induced (gouty) arthritis, or those associated with systemic lupus erythematosus (SLE), spondyloarthropathy, Reiters syndrome, or Crohns disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Baseline, 12 months post dose | Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned. |
| Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | At Month 12 | Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix \[CPM\]). |
| Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | At Month 12 | Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) | 24 months | Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs. |
| Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip | 36 months | Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. The percentage change from baseline in BMD for total hip (assessed by DXA) is presented for the contralateral (untreated) hip below. |
| Number Participant Responses to Injectability Questionnaire Injected Population | Participants were monitored after treatment administration (dosing period) | Investigator documents preparation of the study medication evaluates injectability and product placement relative to desired location (for participants in active treatment groups). Surgeon performing the injection had to complete the questionnaire that evaluates ease of preparing the study medication, ability to administer study medication, and ability for the study medication to remain in the location it was administered. |
| Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline | Baseline up to 12 months | Participants with significant change in serum biomarkers of bone formation and resorption from baseline are reported. Significant changes were judged by investigator. |
Countries
Belgium, Poland, Spain, United States
Participant flow
Recruitment details
The study was conducted at 10 centers in the United States of America, Belgium, and Poland.
Pre-assignment details
Treatment assignments were stratified by previous osteoporosis (OP) therapy regardless of rhBMP-2/CPM treatment assignment; bisphosphonate, calcium, vitamin D were provided to all participants as background concomitant OP therapy.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Control Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 17 |
| rhBMP-2/CPM 1.0 mg/mL Participants had received 1 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP. | 15 |
| rhBMP-2/CPm 2.0 mg/mL Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in treatment groups additionally received SOC treatment for OP. | 14 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Unspecified resaons | 0 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 3 | 3 |
Baseline characteristics
| Characteristic | Total | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL |
|---|---|---|---|---|
| Age, Continuous | 74.15 Years STANDARD_DEVIATION 5.304 | 73.35 Years STANDARD_DEVIATION 5.454 | 75.93 Years STANDARD_DEVIATION 5.271 | 73.21 Years STANDARD_DEVIATION 5.041 |
| Sex: Female, Male Female | 46 Participants | 17 Participants | 15 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 17 | 15 / 15 | 12 / 14 |
| serious Total, serious adverse events | 3 / 17 | 7 / 15 | 7 / 14 |
Outcome results
Primary
Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA)
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure. BMD is defined as a derived measure of bone density, generated by dividing the bone mineral content value obtained from a bone densitometry technique (for example, DXA) by the total area of the region scanned.
Time frame: Baseline, 12 months post dose
Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Control | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Total hip | -0.0026 gram per centimeter squared (g/cm^2) | Standard Deviation 0.018 |
| Standard of Care Control | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Intertrochanter | -0.0029 gram per centimeter squared (g/cm^2) | Standard Deviation 0.02 |
| Standard of Care Control | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Trochanter | -0.0091 gram per centimeter squared (g/cm^2) | Standard Deviation 0.023 |
| Standard of Care Control | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Femoral neck | 0.0058 gram per centimeter squared (g/cm^2) | Standard Deviation 0.021 |
| rhBMP-2/CPM 1.0 mg/mL | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Femoral neck | 0.2408 gram per centimeter squared (g/cm^2) | Standard Deviation 0.111 |
| rhBMP-2/CPM 1.0 mg/mL | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Total hip | 0.1299 gram per centimeter squared (g/cm^2) | Standard Deviation 0.045 |
| rhBMP-2/CPM 1.0 mg/mL | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Trochanter | 0.1197 gram per centimeter squared (g/cm^2) | Standard Deviation 0.066 |
| rhBMP-2/CPM 1.0 mg/mL | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Intertrochanter | 0.1063 gram per centimeter squared (g/cm^2) | Standard Deviation 0.066 |
| rhBMP-2/CPm 2.0 mg/mL | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Femoral neck | 0.2120 gram per centimeter squared (g/cm^2) | Standard Deviation 0.117 |
| rhBMP-2/CPm 2.0 mg/mL | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Intertrochanter | 0.1192 gram per centimeter squared (g/cm^2) | Standard Deviation 0.063 |
| rhBMP-2/CPm 2.0 mg/mL | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Trochanter | 0.0869 gram per centimeter squared (g/cm^2) | Standard Deviation 0.073 |
| rhBMP-2/CPm 2.0 mg/mL | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) | Total hip | 0.1196 gram per centimeter squared (g/cm^2) | Standard Deviation 0.063 |
Primary
Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip
Time course distribution of volumetric Bone mineral density (BMD) for hip is assessed by volumetric Quantitative Computed Tomography (vQCT) technique which is a 4-detector spiral (helical) computed tomography (CT) scanner with designated calibration phantom, obtain a CT scan of the proximal femora (bilateral simultaneous acquisition with volumetric rendering) to identify the specified region of interests (ROIs) for volumetric parameter to be quantified, reconstruct images of both hips and send reconstructed data (in electronic format). The vQCT regions of interest are cortical, the subcortical and trabecular. Cortical and the subcortical BMD are distinguished from trabecular effects. Peeled trabecular BMD reflects the subtraction of the extended CPM. Integral BMD reflects the cortical, subcortical, and peeled trabecular regions (minus the extended Calcium phosphate matrix \[CPM\]).
Time frame: At Month 12
Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Control | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | Peeled Trabecular | 45.1 milligram per centimeter cubed (mg/cm^3) | Standard Deviation 16.02 |
| Standard of Care Control | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | Cortical + Sub-Cortical | 136.8 milligram per centimeter cubed (mg/cm^3) | Standard Deviation 16.91 |
| Standard of Care Control | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | Integral | 181.9 milligram per centimeter cubed (mg/cm^3) | Standard Deviation 20.6 |
| rhBMP-2/CPM 1.0 mg/mL | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | Peeled Trabecular | 77.8 milligram per centimeter cubed (mg/cm^3) | Standard Deviation 23.07 |
| rhBMP-2/CPM 1.0 mg/mL | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | Cortical + Sub-Cortical | 165.6 milligram per centimeter cubed (mg/cm^3) | Standard Deviation 18.37 |
| rhBMP-2/CPM 1.0 mg/mL | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | Integral | 243.4 milligram per centimeter cubed (mg/cm^3) | Standard Deviation 31.04 |
| rhBMP-2/CPm 2.0 mg/mL | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | Cortical + Sub-Cortical | 151.6 milligram per centimeter cubed (mg/cm^3) | Standard Deviation 26.07 |
| rhBMP-2/CPm 2.0 mg/mL | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | Integral | 240.0 milligram per centimeter cubed (mg/cm^3) | Standard Deviation 45.31 |
| rhBMP-2/CPm 2.0 mg/mL | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip | Peeled Trabecular | 88.4 milligram per centimeter cubed (mg/cm^3) | Standard Deviation 37.63 |
Primary
Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. Alternatively, if changes in the total area surrounding the proximal femur are observed, bone mineral content (BMC) may instead be applied for the primary measure.
Time frame: At Month 12
Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Control | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | Peeled Trabecular | 61.1 mg/cm^3 | Standard Deviation 14.39 |
| Standard of Care Control | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | Cortical +Sub Cortical | 144.3 mg/cm^3 | Standard Deviation 16.81 |
| Standard of Care Control | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | Integral | 205.4 mg/cm^3 | Standard Deviation 23.02 |
| rhBMP-2/CPM 1.0 mg/mL | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | Peeled Trabecular | 165.0 mg/cm^3 | Standard Deviation 59.13 |
| rhBMP-2/CPM 1.0 mg/mL | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | Cortical +Sub Cortical | 166.3 mg/cm^3 | Standard Deviation 31.06 |
| rhBMP-2/CPM 1.0 mg/mL | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | Integral | 331.3 mg/cm^3 | Standard Deviation 73.99 |
| rhBMP-2/CPm 2.0 mg/mL | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | Cortical +Sub Cortical | 164.4 mg/cm^3 | Standard Deviation 29.37 |
| rhBMP-2/CPm 2.0 mg/mL | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | Integral | 323.7 mg/cm^3 | Standard Deviation 58.96 |
| rhBMP-2/CPm 2.0 mg/mL | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck | Peeled Trabecular | 159.3 mg/cm^3 | Standard Deviation 38.97 |
Secondary
Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline
Participants with significant change in serum biomarkers of bone formation and resorption from baseline are reported. Significant changes were judged by investigator.
Time frame: Baseline up to 12 months
Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants in the as-treated population are grouped according to the treatment they received (not the treatment to which they were randomly assigned).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard of Care Control | Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline | 0 participants |
| rhBMP-2/CPM 1.0 mg/mL | Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline | 0 participants |
| rhBMP-2/CPm 2.0 mg/mL | Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline | 0 participants |
Secondary
Number Participant Responses to Injectability Questionnaire Injected Population
Investigator documents preparation of the study medication evaluates injectability and product placement relative to desired location (for participants in active treatment groups). Surgeon performing the injection had to complete the questionnaire that evaluates ease of preparing the study medication, ability to administer study medication, and ability for the study medication to remain in the location it was administered.
Time frame: Participants were monitored after treatment administration (dosing period)
Population: Only those participants who were injected with rhBMP-2/CPM were included in the injected population. Any participant who received SOC alone was excluded from this population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care Control | Number Participant Responses to Injectability Questionnaire Injected Population | Ease of Preparing-unsatisfactory | 0 Participants |
| Standard of Care Control | Number Participant Responses to Injectability Questionnaire Injected Population | Ability to inject entire volume- unsatisfactory | 2 Participants |
| Standard of Care Control | Number Participant Responses to Injectability Questionnaire Injected Population | Ease of Injecting-unsatisfactory | 0 Participants |
| Standard of Care Control | Number Participant Responses to Injectability Questionnaire Injected Population | Localization within Proximal Femur-satisfactory | 15 Participants |
| Standard of Care Control | Number Participant Responses to Injectability Questionnaire Injected Population | Ease of Injecting-satisfactory | 15 Participants |
| Standard of Care Control | Number Participant Responses to Injectability Questionnaire Injected Population | Localization within Proximal Femur-unsatisfactory | 0 Participants |
| Standard of Care Control | Number Participant Responses to Injectability Questionnaire Injected Population | Ability to inject entire volume- satisfactory | 13 Participants |
| Standard of Care Control | Number Participant Responses to Injectability Questionnaire Injected Population | Missing | 0 Participants |
| Standard of Care Control | Number Participant Responses to Injectability Questionnaire Injected Population | Ease of Preparing-satisfactory | 15 Participants |
| rhBMP-2/CPM 1.0 mg/mL | Number Participant Responses to Injectability Questionnaire Injected Population | Missing | 1 Participants |
| rhBMP-2/CPM 1.0 mg/mL | Number Participant Responses to Injectability Questionnaire Injected Population | Ease of Preparing-satisfactory | 14 Participants |
| rhBMP-2/CPM 1.0 mg/mL | Number Participant Responses to Injectability Questionnaire Injected Population | Ease of Preparing-unsatisfactory | 0 Participants |
| rhBMP-2/CPM 1.0 mg/mL | Number Participant Responses to Injectability Questionnaire Injected Population | Ease of Injecting-satisfactory | 11 Participants |
| rhBMP-2/CPM 1.0 mg/mL | Number Participant Responses to Injectability Questionnaire Injected Population | Ease of Injecting-unsatisfactory | 3 Participants |
| rhBMP-2/CPM 1.0 mg/mL | Number Participant Responses to Injectability Questionnaire Injected Population | Ability to inject entire volume- satisfactory | 12 Participants |
| rhBMP-2/CPM 1.0 mg/mL | Number Participant Responses to Injectability Questionnaire Injected Population | Ability to inject entire volume- unsatisfactory | 2 Participants |
| rhBMP-2/CPM 1.0 mg/mL | Number Participant Responses to Injectability Questionnaire Injected Population | Localization within Proximal Femur-satisfactory | 11 Participants |
| rhBMP-2/CPM 1.0 mg/mL | Number Participant Responses to Injectability Questionnaire Injected Population | Localization within Proximal Femur-unsatisfactory | 2 Participants |
Secondary
Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip
Evaluating local changes (expected increases) in BMD after administration of rhBMP-2/CPM, compared to those observed with systemic osteoporosis therapy alone. The percentage change from baseline in BMD for total hip (assessed by DXA) is presented for the contralateral (untreated) hip below.
Time frame: 36 months
Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Control | Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip | 0.73 Percent change | Standard Deviation 0.057 |
| rhBMP-2/CPM 1.0 mg/mL | Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip | 0.71 Percent change | Standard Deviation 0.045 |
| rhBMP-2/CPm 2.0 mg/mL | Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip | 0.71 Percent change | Standard Deviation 0.11 |
Secondary
Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC)
Here, measurement of density of cortical and trabecular bone in various regions of interest (ROIs) in the femoral neck, proximal shaft, and individual trochanters and was calculated by Quantitative Computed Tomography (vQTC) in ROIs.
Time frame: 24 months
Population: As-treated population included randomly assigned participants who received at least 1 dose of rhBMP-2/CPM or comparator agent. Participants were grouped as per the treatment they received (not to the treatment they were randomly assigned). Here, overall number of participants analyzed = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Control | Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) | Cortical Bone | 2.5782 mg/cm^3 | Standard Deviation 0.16805 |
| Standard of Care Control | Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) | Trabecular Bone | 0 mg/cm^3 | Standard Deviation 0 |
| rhBMP-2/CPM 1.0 mg/mL | Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) | Cortical Bone | 2.4259 mg/cm^3 | Standard Deviation 0.24267 |
| rhBMP-2/CPM 1.0 mg/mL | Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) | Trabecular Bone | 4.7073 mg/cm^3 | Standard Deviation 2.405 |
| rhBMP-2/CPm 2.0 mg/mL | Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) | Cortical Bone | 2.5128 mg/cm^3 | Standard Deviation 0.17484 |
| rhBMP-2/CPm 2.0 mg/mL | Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) | Trabecular Bone | 4.2205 mg/cm^3 | Standard Deviation 1.63904 |