Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00752557
Collaborator
(none)
50
35
3
76.6
1.4
0
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A PHASE 2, MULTICENTER, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, DOSE-FINDING AND SAFETY STUDY OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2)/CALCIUM PHOSPHATE MATRIX(CPM) IN SUBJECTS WITH DECREASED BONE MINERAL DENSITY
Actual Study Start Date
:
Dec 3, 2008
Actual Primary Completion Date
:
Apr 24, 2015
Actual Study Completion Date
:
Apr 24, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 rhBMP-2/CPM , 1.0 mg/mL |
Drug: rhBMP-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.
|
| Experimental: 2 rhBMP-2/CPM , 2.0 mg/mL |
Drug: rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy)
Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.
|
| Active Comparator: 3 Oral bisphosphonate therapy (standard of care) |
Drug: bisphosphonates, calcium, and vitamin D
Oral bisphosphonate therapy
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
to 85 Years
Sexes Eligible for Study:
Female
Accepts 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona Research Center, Inc. | Phoenix | Arizona | United States | 85023 |
| 2 | John C. Lincoln Hospital - Deer Valley | Phoenix | Arizona | United States | 85027 |
| 3 | Tucson Orthopaedic Institute | Tucson | Arizona | United States | 85712 |
| 4 | UC Davis Medical Center | Sacramento | California | United States | 95817 |
| 5 | Florida Hospital Deland | DeLand | Florida | United States | 32720 |
| 6 | Florida Orthopaedic Associates, P.A. | DeLand | Florida | United States | 32720 |
| 7 | Florida Research Associates, LLC | DeLand | Florida | United States | 32720 |
| 8 | Victoria Park Imaging | DeLand | Florida | United States | 32724 |
| 9 | Diagnostic Professionals, Inc. | Fort Lauderdale | Florida | United States | 33311 |
| 10 | Shrock Orthopedic Research | Fort Lauderdale | Florida | United States | 33316 |
| 11 | Suncoast Clinical Research Inc | New Port Richey | Florida | United States | 34652 |
| 12 | Coastal orthopedic and Sports Medicine | New Port Richey | Florida | United States | 34653 |
| 13 | Westside Regional Medical Center | Plantation | Florida | United States | 33324 |
| 14 | Florida Arthritis & Osteoporosis Center | Port Richey | Florida | United States | 34668 |
| 15 | Medical Center of Trinity | Trinity | Florida | United States | 34655 |
| 16 | Intensive Research Unit | Saint Louis | Missouri | United States | 63110 |
| 17 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 18 | Center for Advanced Medicine | Saint Louis | Missouri | United States | 63310 |
| 19 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131 |
| 20 | Creighton University Osteoporosis Research Center | Omaha | Nebraska | United States | 68131 |
| 21 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 22 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 23 | University Orthopedics Center | Altoona | Pennsylvania | United States | 16602 |
| 24 | University Orthopedics Center | State College | Pennsylvania | United States | 16801 |
| 25 | Prairie Lakes Healthcare Systems | Watertown | South Dakota | United States | 57201G |
| 26 | Brown Clinic | Watertown | South Dakota | United States | 57201 |
| 27 | Cool Spring Interventional, PLLC | Franklin | Tennessee | United States | 37067 |
| 28 | Center for Women's Health Research at Meharry Medical College | Nashville | Tennessee | United States | 37208-3599 |
| 29 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 30 | Andre Dumont Ziekenhuis - ZOL, Campus Andre Dumont | Waterschei (Genk) | Belgium | 3600 | |
| 31 | Radiologica, Pracownia Rezonansu Magnetycznego i Tomografii Komputerowej | Warsaw | Mazowieckie | Poland | 01-258 |
| 32 | Synexus Polska Sp. z o.o. | Warszawa | Mazowieckie | Poland | 01-192 |
| 33 | Centralny Szpital Kliniczny MSWiA, Zaklad Diagnostyki Radiologicznej | Warszawa | Mazowieckie | Poland | 02-507 |
| 34 | Clinica Ruber | Madrid | Spain | 28006 | |
| 35 | Instituto Palacios de Salud y Medicina de la Mujer | Madrid | Spain | 28009 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00752557
Other Study ID Numbers:
- 3100N0-2213
- B1921002
- 2007-007456-34
First Posted:
Sep 15, 2008
Last Update Posted:
Mar 20, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted at 10 centers in the United States of America, Belgium, and Poland. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPM 2.0mg/mL |
|---|---|---|---|
| Arm/Group Description | Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 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. | Participants had received 2 mg/mL rhBMP 2/CPM administered via intraosseous injection administered percutaneously to the proximal femur. Participants in both injected treatment groups additionally received SOC treatment for OP. |
| Period Title: Overall Study | |||
| STARTED | 17 | 16 | 17 |
| COMPLETED | 12 | 11 | 11 |
| NOT COMPLETED | 5 | 5 | 6 |
Baseline Characteristics
| Arm/Group Title | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 17 | 15 | 14 | 46 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
73.35
(5.454)
|
75.93
(5.271)
|
73.21
(5.041)
|
74.15
(5.304)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
17
100%
|
15
100%
|
14
100%
|
46
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL |
|---|---|---|---|
| Arm/Group Description | Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 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. | 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. |
| Measure Participants | 14 | 12 | 14 |
| Total hip |
-0.0026
(0.018)
|
0.1299
(0.045)
|
0.1196
(0.063)
|
| Intertrochanter |
-0.0029
(0.020)
|
0.1063
(0.066)
|
0.1192
(0.063)
|
| Trochanter |
-0.0091
(0.023)
|
0.1197
(0.066)
|
0.0869
(0.073)
|
| Femoral neck |
0.0058
(0.021)
|
0.2408
(0.111)
|
0.2120
(0.117)
|
| Title | Time Course Distribution of Volumetric BMD for the Hip Under Study (HUS) for Total Hip |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL |
|---|---|---|---|
| Arm/Group Description | Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 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. | 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. |
| Measure Participants | 13 | 11 | 14 |
| Cortical + Sub-Cortical |
136.8
(16.91)
|
165.6
(18.37)
|
151.6
(26.07)
|
| Peeled Trabecular |
45.1
(16.02)
|
77.8
(23.07)
|
88.4
(37.63)
|
| Integral |
181.9
(20.60)
|
243.4
(31.04)
|
240.0
(45.31)
|
| Title | Summary of Volumetric Density of Cortical and Trabecular Bone Calculated by Quantitative Computed Tomography (vQTC) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL |
|---|---|---|---|
| Arm/Group Description | Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 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. | 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. |
| Measure Participants | 5 | 7 | 6 |
| Cortical Bone |
2.5782
(0.16805)
|
2.4259
(0.24267)
|
2.5128
(0.17484)
|
| Trabecular Bone |
0
(0)
|
4.7073
(2.40500)
|
4.2205
(1.63904)
|
| Title | Number Participant Responses to Injectability Questionnaire Injected Population |
|---|---|
| Description | 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 15 | 14 |
| Ease of Preparing-satisfactory |
15
88.2%
|
14
93.3%
|
| Ease of Preparing-unsatisfactory |
0
0%
|
0
0%
|
| Ease of Injecting-satisfactory |
15
88.2%
|
11
73.3%
|
| Ease of Injecting-unsatisfactory |
0
0%
|
3
20%
|
| Ability to inject entire volume- satisfactory |
13
76.5%
|
12
80%
|
| Ability to inject entire volume- unsatisfactory |
2
11.8%
|
2
13.3%
|
| Localization within Proximal Femur-satisfactory |
15
88.2%
|
11
73.3%
|
| Localization within Proximal Femur-unsatisfactory |
0
0%
|
2
13.3%
|
| Missing |
0
0%
|
1
6.7%
|
| Title | Number of Participants With Any Significant Changes in Serum Biomarkers of Bone Turnover From Baseline |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL |
|---|---|---|---|
| Arm/Group Description | Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 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. | 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. |
| Measure Participants | 17 | 15 | 14 |
| Number [participants] |
0
0%
|
0
0%
|
0
0%
|
| Title | Timecourse Distribution of Volumetric Bone Mineral Density (BMD) for the Hip Under Study (HUS). Volume of Interest: Femoral Neck |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL |
|---|---|---|---|
| Arm/Group Description | Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 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. | 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. |
| Measure Participants | 13 | 11 | 14 |
| Cortical +Sub Cortical |
144.3
(16.81)
|
166.3
(31.06)
|
164.4
(29.37)
|
| Peeled Trabecular |
61.1
(14.39)
|
165.0
(59.13)
|
159.3
(38.97)
|
| Integral |
205.4
(23.02)
|
331.3
(73.99)
|
323.7
(58.96)
|
| Title | Percentage Change From Baseline in Areal Bone Mineral Density (BMD) for Contralateral Total Hip |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL |
|---|---|---|---|
| Arm/Group Description | Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 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. | 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. |
| Measure Participants | 10 | 12 | 12 |
| Mean (Standard Deviation) [Percent change] |
0.73
(0.057)
|
0.71
(0.045)
|
0.71
(0.110)
|
Adverse Events
| Time Frame | Adverse events were collected from the time of written informed consent through 3 years, month 36 (Visit 10) for SOC participants and through Visit 12 (month 60) for participants who either received 1.0 mg/mL or 2.0 mg/mL of rhBMP-2/CPM. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The 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/Group Title | Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL | |||
| Arm/Group Description | Participants had received systemic osteoporosis therapy with an oral bisphosphonate plus supplemental calcium, and vitamin D as prescribed by the study physician. | 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. | 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. | |||
All Cause Mortality |
||||||
| Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/17 (17.6%) | 7/15 (46.7%) | 7/14 (50%) | |||
| Cardiac disorders | ||||||
| Angina Pectoris | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Myocardial Infarction | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Gastrointestinal disorders | ||||||
| Oesophagitis | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Infections and infestations | ||||||
| Bronchopneumonia | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Cystitis | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Injury, poisoning and procedural complications | ||||||
| Femur fracture | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Humerus fracture | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Procedural pain | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Rib fracture | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Road traffic accident | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Fall | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Femoral neck fracture | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Investigations | ||||||
| Nuclear magnetic resonance imaging abnormal | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Bone infarction | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Intervertebral disc protrusion | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Joint range of motion decreased | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Osteoarthritis | 0/17 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Osteonecrosis | 0/17 (0%) | 0/15 (0%) | 2/14 (14.3%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Basal cell carcinoma | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Thyroid neoplasm | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Nervous system disorders | ||||||
| Intracranial aneurysm | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Syncope | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Transient ischaemic attack | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Renal and urinary disorders | ||||||
| Haematuria | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Pneumothorax | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Pulmonary mass | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Standard of Care Control | rhBMP-2/CPM 1.0 mg/mL | rhBMP-2/CPm 2.0 mg/mL | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/17 (76.5%) | 15/15 (100%) | 12/14 (85.7%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/17 (5.9%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Bone marrow oedema | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Lymph node calcification | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Lymphadenopathy | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Cardiac disorders | ||||||
| Atrioventricular block first degree | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Chronotropic incompetence | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Supraventricular extrasystoles | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Ear pain | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Vertigo | 0/17 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Endocrine disorders | ||||||
| Hypothyroidism | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Eye disorders | ||||||
| Blepharitis | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Choroidal haemorrhage | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Dark circles under eyes | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Eye pain | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Eyelid ptosis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Cataract | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Macular generation | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Ocular hyperaemia | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| retinal haemorrhage | 1/17 (5.9%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Visual acuity reduced | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Gastrointestinal disorders | ||||||
| Abdominal distension | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Abdominal pain upper | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Cheilitis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Constipation | 1/17 (5.9%) | 3/15 (20%) | 0/14 (0%) | |||
| Diarrhoea | 0/17 (0%) | 2/15 (13.3%) | 0/14 (0%) | |||
| Dry mouth | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Dyspepsia | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Dysphagia | 0/17 (0%) | 2/15 (13.3%) | 0/14 (0%) | |||
| Gastric ulcer | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Gastritis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Gastrooesophageal reflux disease | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Haemorrhoids | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Hiatus hernia | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Nausea | 1/17 (5.9%) | 6/15 (40%) | 5/14 (35.7%) | |||
| Oesophagitis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Oral discomfort | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Pancreatic cyst | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Vomiting | 0/17 (0%) | 3/15 (20%) | 3/14 (21.4%) | |||
| General disorders | ||||||
| Breakthrough pain | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Chills | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Facial pain | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Fatigue | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Gait deviation | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Gait disturbance | 1/17 (5.9%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Injection site bruising | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Injection site discharge | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Injection site erythema | 0/17 (0%) | 2/15 (13.3%) | 0/14 (0%) | |||
| Injection site mass | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Injection site pain | 0/17 (0%) | 0/15 (0%) | 5/14 (35.7%) | |||
| Injection site swelling | 0/17 (0%) | 2/15 (13.3%) | 0/14 (0%) | |||
| Malaise | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Non-cardiac chest pain | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Oedema | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Oedema peripheral | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Pain | 2/17 (11.8%) | 2/15 (13.3%) | 1/14 (7.1%) | |||
| Peripheral swelling | 1/17 (5.9%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Pyrexia | 0/17 (0%) | 0/15 (0%) | 2/14 (14.3%) | |||
| Soft tissue inflammation | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Immune system disorders | ||||||
| Seasonal allergy | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Infections and infestations | ||||||
| Arthritis infective | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Bronchitis | 1/17 (5.9%) | 2/15 (13.3%) | 2/14 (14.3%) | |||
| Coccidioidomycosis | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Cystitis | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Diarrhoea infectious | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Gastroenteritis viral | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Influenza | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Labyrinthitis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Lung infection | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Nasopharyngitis | 0/17 (0%) | 0/15 (0%) | 2/14 (14.3%) | |||
| Onychomycosis | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Oral herpes | 0/17 (0%) | 0/15 (0%) | 2/14 (14.3%) | |||
| Osteomyelitis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Pharyngitis streptococcal | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Pneumonia | 0/17 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Rhinitis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Sinusitis | 1/17 (5.9%) | 2/15 (13.3%) | 1/14 (7.1%) | |||
| Tooth infection | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Upper respiratory tract infection | 0/17 (0%) | 0/15 (0%) | 2/14 (14.3%) | |||
| Urinary tract infection | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Vulvovaginal mycotic infection | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Ankle fracture | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Clavicle fracture | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Contusion | 0/17 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Epicondylitis | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Fall | 4/17 (23.5%) | 5/15 (33.3%) | 3/14 (21.4%) | |||
| Fibula fracture | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Hand fracture | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Head injury | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Humerus fracture | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Injection related reaction | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Joint injury | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Laceration | 1/17 (5.9%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Ligament sprain | 2/17 (11.8%) | 0/15 (0%) | 0/14 (0%) | |||
| Limb injury | 0/17 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Lower limb fracture | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Muscle strain | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Patella fracture | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Procedural hypotension | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Procedural pain | 0/17 (0%) | 2/15 (13.3%) | 5/14 (35.7%) | |||
| Road traffic accident | 1/17 (5.9%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Skeletal injury | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Skin abrasion | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Superficial injury of eye | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Thermal burn | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Wound | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Wrist fracture | 0/17 (0%) | 0/15 (0%) | 2/14 (14.3%) | |||
| Investigations | ||||||
| Alanine aminotransferase increased | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Aspartate aminotransferase increased | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Chest X-ray abnormal | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Scan bone marrow abnormal | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Urine output increased | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Weight decreased | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Hypercholesterolaemia | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Hypokalaemia | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Iodine deficiency | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Type 2 diabetes mellitus | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 5/17 (29.4%) | 12/15 (80%) | 9/14 (64.3%) | |||
| Arthritis | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Back pain | 2/17 (11.8%) | 4/15 (26.7%) | 3/14 (21.4%) | |||
| Bone pain | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Bursitis | 1/17 (5.9%) | 2/15 (13.3%) | 1/14 (7.1%) | |||
| Exostosis | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Foot deformity | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Groin pain | 0/17 (0%) | 2/15 (13.3%) | 0/14 (0%) | |||
| Intervertebral disc degeneration | 1/17 (5.9%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Joint effusion | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Joint range of motion decreased | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Joint swelling | 2/17 (11.8%) | 3/15 (20%) | 4/14 (28.6%) | |||
| Limb discomfort | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Mobility decreased | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Muscle spasms | 1/17 (5.9%) | 2/15 (13.3%) | 1/14 (7.1%) | |||
| Muscle swelling | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Muscular weakness | 0/17 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Musculoskeletal discomfort | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Musculoskeletal pain | 2/17 (11.8%) | 3/15 (20%) | 2/14 (14.3%) | |||
| Musculoskeletal stiffness | 2/17 (11.8%) | 1/15 (6.7%) | 2/14 (14.3%) | |||
| Myalgia | 1/17 (5.9%) | 2/15 (13.3%) | 0/14 (0%) | |||
| Osteitis | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Osteoarthritis | 1/17 (5.9%) | 2/15 (13.3%) | 2/14 (14.3%) | |||
| Pain in extremity | 3/17 (17.6%) | 2/15 (13.3%) | 4/14 (28.6%) | |||
| Pain in jaw | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Periarthritis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Plantar fasciitis | 1/17 (5.9%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Scoliosis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Spinal osteoarthritis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Synovitis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Temporomandibular joint syndrome | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Tendonitis | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Vertebral osteophyte | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Weight bearing difficulty | 0/17 (0%) | 2/15 (13.3%) | 1/14 (7.1%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Basal cell carcinoma | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Benign neoplasm of skin | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Choroid melanoma | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Colon adenoma | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Dysplastic naevus | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Neoplasm | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Seborrhoeic keratosis | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Skin papilloma | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Tumour ulceration | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Nervous system disorders | ||||||
| Balance disorder | 1/17 (5.9%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Dizziness | 1/17 (5.9%) | 0/15 (0%) | 2/14 (14.3%) | |||
| Dizziness postural | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Headache | 1/17 (5.9%) | 1/15 (6.7%) | 2/14 (14.3%) | |||
| Hypoaesthesia | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Lethargy | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Loss of consciousness | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Meralgia paraesthetica | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Neuralgia | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Peroneal nerve palsy | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Sciatica | 0/17 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Sinus headache | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| VIIth nerve paralysis | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Psychiatric disorders | ||||||
| Depression | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Anxiety | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Insomnia | 0/17 (0%) | 0/15 (0%) | 2/14 (14.3%) | |||
| Renal and urinary disorders | ||||||
| Dysuria | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Haematuria | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Incontinence | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Renal failure | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Reproductive system and breast disorders | ||||||
| Vulvovaginal discomfort | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Vulvovaginal pruritus | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Atelectasis | 0/17 (0%) | 2/15 (13.3%) | 1/14 (7.1%) | |||
| Choking sensation | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Cough | 3/17 (17.6%) | 1/15 (6.7%) | 3/14 (21.4%) | |||
| Dyspnoea exertional | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Nasal congestion | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Oropharyngeal pain | 2/17 (11.8%) | 2/15 (13.3%) | 1/14 (7.1%) | |||
| Productive cough | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Rhinorrhoea | 1/17 (5.9%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Sinus congestion | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Acne | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Dandruff | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Dermatitis allergic | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Dry skin | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Erythema | 0/17 (0%) | 2/15 (13.3%) | 1/14 (7.1%) | |||
| Ingrowing nail | 1/17 (5.9%) | 0/15 (0%) | 0/14 (0%) | |||
| Rash | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Skin lesion | 1/17 (5.9%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Urticaria | 0/17 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | |||
| Vascular disorders | ||||||
| Aortic calcification | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
| Hypertension | 0/17 (0%) | 0/15 (0%) | 1/14 (7.1%) | |||
| Hypotension | 0/17 (0%) | 2/15 (13.3%) | 0/14 (0%) | |||
| Vascular calcification | 0/17 (0%) | 1/15 (6.7%) | 0/14 (0%) | |||
Limitations/Caveats
46 participants enrolled; further enrollment suspended due to safety signal. Participants completed long-term follow up per protocol; extra 2 years per protocol amendment. Sample size small to draw conclusions, to conduct efficacy interim analysis.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study participating sites. Investigator may not disclose previously undisclosed confidential other than study results.
Results Point of Contact
| Name/Title | Pfizer ClinicalTrials.gov Call Center |
|---|---|
| Organization | Pfizer Inc. |
| Phone | 1-800-718-1021 |
| ClinicalTrials.gov_Inquiries@pfizer.com |
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00752557
Other Study ID Numbers:
- 3100N0-2213
- B1921002
- 2007-007456-34
First Posted:
Sep 15, 2008
Last Update Posted:
Mar 20, 2020
Last Verified:
Mar 1, 2020